A Medical Device Coordination Group (‘MDCG’) is hereby established.
2.
Each Member State shall appoint to the MDCG, for a three-year term which may be renewed, one member and one alternate each with expertise in the field of medical devices, and one member and one alternate with expertise in the field of in vitro diagnostic medical devices. A Member State may choose to appoint only one member and one alternate, each with expertise in both fields.
The members of the MDCG shall be chosen for their competence and experience in the field of medical devices and in vitro diagnostic medical devices. They shall represent the competent authorities of the Member States. The names and affiliation of members shall be made public by the Commission.
The alternates shall represent and vote for the members in their absence.
3.
The MDCG shall meet at regular intervals and, where the situation requires, upon request by the Commission or a Member State. The meetings shall be attended either by the members appointed for their role and expertise in the field of medical devices, or by the members appointed for their expertise in the field of in vitro diagnostic medical devices, or by the members appointed for their expertise in both fields, or their alternates, as appropriate.
4.
The MDCG shall use its best endeavours to reach consensus. If such consensus cannot be reached, the MDCG shall decide by a majority of its members. Members with diverging positions may request that their positions and the grounds on which they are based be recorded in the MDCG's position.
5.
The MDCG shall be chaired by a representative of the Commission. The chair shall not take part in votes of the MDCG.
6.
The MDCG may invite, on a case-by-case basis, experts and other third parties to attend meetings or provide written contributions.
7.
The MDCG may establish standing or temporary sub-groups. Where appropriate, organisations representing the interests of the medical device industry, healthcare professionals, laboratories, patients and consumers at Union level shall be invited to such sub-groups in the capacity of observers.
8.
The MDCG shall establish its rules of procedure which shall, in particular, lay down procedures for the following:
—
the adoption of opinions or recommendations or other positions, including in cases of urgency;
—
the delegation of tasks to reporting and co-reporting members;
—
the implementation of Article 107 regarding conflict of interests;
—
the functioning of sub-groups.
9.
The MDCG shall have the tasks laid down in Article 105 of this Regulation and Article 99 of Regulation (EU) 2017/746.
Official catalogue · non-binding
Related guidance (112)
Current English catalogue entries that refer to Article 103. Guidance is non-binding and kept separate from the regulation text.
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2023-5Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodiesDecember 2023⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
Manual on BorderlineManual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5 Background note on the use of the Manual on borderline and classification for medical devices under the Directives.April 2026⌄
Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5PDF · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-13Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devicesOctober 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2022-5 rev.1Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devicesOctober 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-24 rev.1Guidance on classification of medical devicesApril 2026⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2019-15 rev.1Guidance notes for manufacturers of class I medical devicesDecember 2019⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-15Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMEDNovember 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
Show all 112 guidance documentsShow only the first 8
MDCG 2024-10Clinical evaluation of orphan medical devicesJune 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-5 MDCG 2024-5 Appendix AGuidance on the Investigator’s Brochure contentAppendix A of the MDCG 2024-5April2024April2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-3 MDCG 2024-3 Appendix AGuidance on content of the Clinical Investigation Plan for clinical investigations of medical devicesClinical Investigation Plan Synopsis TemplateMarch 2024March 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2023-7Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on sufficient levels of access’ to data needed to justify claims of equivalenceDecember 2023⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-28Substantial modification of clinical investigation under Medical Device RegulationDecember 2021⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-20Instructions for generating CIV-ID for MDR Clinical InvestigationsJuly 2021⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2020-13 - Word versionClinical evaluation assessment report templateJuly 2020⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Word versionDOCX · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2020-10/1 rev.1 MDCG 2020-10/2 rev.1Guidance on safety reporting in clinical investigationsAppendix: Clinical investigation summary safety report formOctober 2022October 2022⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2020-8Guidance on PMCF evaluation report templateApril 2020⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2020-7Guidance on PMCF plan templateApril 2020⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2020-6Guidance on sufficient clinical evidence for legacy devicesBackground note on the relationship between MDCG 2020-6 and MEDDEV 2.7/1 rev.4 on clinical evaluationApril 2020⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2020-5Guidance on clinical evaluation – EquivalenceApril 2020⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2019-9 - rev.1Summary of safety and clinical performanceMarch 2022⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-21 rev.1Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devicesFebruary 2022⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2022-1Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devicesJanuary 2022⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-7Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devicesMay 2021⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-2Guidance on state of the art of COVID-19 rapid antibody testsMarch 2021⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2020-9Regulatory requirements for ventilators and related accessoriesApril 2020⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-3Questions and Answers on Custom-Made DevicesMarch 2021⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2026-4MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory useJune 2026⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-13 rev.1Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDRJuly 2021⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-1 rev.1Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functionalMay 2021⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-2 rev.1Procedures for the updates of the EMDNJanuary 2025⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-12 rev.2FAQ on the European Medical Device Nomenclature (EMDN)April 2026⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2018-2Future EU medical device nomenclature - Description of requirementsMarch 2018⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-11Guidance on Implant Card – Device typesMay 2021⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2019-8 v2Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devicesMarch 2020⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2023-1Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746January 2023⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-27 - rev.1Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746December 2023⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2022-16Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746October 2022⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-26Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746October 2021⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-11Guidance on qualification of in vitro diagnostic medical devicesOctober 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2022-9 rev.1Summary of safety and performance templateApril 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2022-8Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/ECMay 2022⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2022-3 rev.1Verification of manufactured class D IVDs by notified bodiesDecember 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2022-2Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)January 2022⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2025-9Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746Note: Pilot to roll-out the guidance is expected to be launched in Q2 2026December 2025⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2025-6FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)June 2025⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2025-4Guidance on the safe making available of medical device software (MDSW) apps on online platformsJune 2025⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2023-4Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware componentsOctober 2023⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2020-1Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device softwareMarch 2020⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2019-16 rev.1Guidance on cybersecurity for medical devicesJuly 2020⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2019-11 rev.1Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746June 2025⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-6Preliminary re-assessment review (PRAR) form template (MDR)May 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-7 rev.1 MDCG 2021-15/MDCG 2024-7 AnnexPreliminary assessment review (PAR) form template (MDR) Annex to Application Form & PAR Template MDR (List of documents)January 2025⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-8 rev.1 MDCG 2021-16/MDCG 2024-8 AnnexPreliminary assessment review (PAR) form template (IVDR) Annex to Application Form & PAR Template IVDR (List of documents)January 2025⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-9Preliminary re-assessment review (PRAR) form template (IVDR)May 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2020-3 rev.1Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDDNote to the reader: Due to technical issues, please disregard the document displayed from 7 September 2023 until 8 September 2023.September 2023⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2023-2 MDCG 2023-2 MDR form MDCG 2023-2 IVDR formList of Standard FeesJanuary 2023⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2022-4 rev.2Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDDMay 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2022-17MDCG position paper on "hybrid audits"December 2022⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2019-6 rev.5Questions and answers: Requirements relating to notified bodiesFebruary 2025⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2022-13 rev.1Designation, re-assessment and notification of conformity assessment bodies and notified bodiesJune 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-12 MDCG 2024-12 Annex I Form MDCG 2024-12 Annex II FormCorrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities, and joint assessment teamsAnnex I: Template CAPA plan and assessment thereonAnnex II: Template JAT review of the CAPA and the DA's opinionOctober 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
MDCG 2024-12 Annex I FormDOCX · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
MDCG 2024-12 Annex II FormDOCX · Unverified extraction previewOfficial source
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-23Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746August 2021⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-18Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)July 2021⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-17Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)July 2021⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-16 rev.1 MDCG 2021-16/MDCG 2024-8 AnnexApplication form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR)Annex to Application Form & PAR Template IVDR (List of documents)January 2025⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-15 rev.1 MDCG 2021-15/MDCG 2024-7 AnnexApplication form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR)Annex to Application Form & PAR Template MDR (List of documents)January 2025⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2020-17Questions and Answers related to MDCG 2020-4:“Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions”December 2020⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2020-14Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR)August 2020⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2020-12Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissuesJune 2020⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2020-11Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013May 2020⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2020-4Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictionsApril 2020⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2019-14Explanatory note on MDR codesDecember 2019⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2019-13 rev.1Guidance on sampling of devices for the assessment of the technical documentationDecember 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2018-8Guidance on content of the certificates, voluntary certificate transfersNovember 2018⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
NBOG BPG 2017-2Best practice guidance on the information required for personnel involved in conformity assessmentFebruary 2018⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2019-7 - rev.1Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)December 2023⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2025–10Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devicesDecember 2025⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-1Device Specific Vigilance Guidance (DSVG) TemplateJanuary 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-1-1DSVG 01 on Cardiac ablationJanuary 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-1-2DSVG 02 on Coronary stentsJanuary 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-1-3DSVG 03 on Cardiac implantable electronic devices (CIEDs)January 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-1-4DSVG 04 on Breast implantsJanuary 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-1-5DSVG 05 on Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary IncontinenceJune 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2023-3 rev.2Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746January 2025⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2022-21Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745December 2022⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-5 rev.1Guidance on standardisation for medical devicesJuly 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-5 rev.1 - AppendixTransition to the "EU REP" symbol in EN ISO 15223-1June 2026⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2026-5Position Paper: UDI assignment between manufacturers and distributorsJuly 2026⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2025-8 - rev.1Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectaclesMarch 2026⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2025-7 Rev 1MDCG Position Paper: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectaclesDecember 2025⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-14 - rev.1Guidance on the implementation of the Master UDI-DI solution for contact lensesAugust 2025⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2022-7Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU)May 2022⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-19Guidance note integration of the UDI within an organisation’s quality management systemJuly 2021⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-10The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devicesJune 2021⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2018-1 rev.4Guidance on basic UDI-DI and changes to UDI-DIApril 2021⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2019-2Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017February 2019⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2019-1MDCG guiding principles for issuing entities rules on basic UDI-DIJanuary 2019⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2018-7Provisional considerations regarding language issues associated with the UDI databaseOctober 2018⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2018-6Clarifications of UDI related responsibilities in relation to article 16October 2018⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2018-5UDI assignment to medical device softwareOctober 2018⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2018-4Definitions/descriptions and formats of the UDI core elements for systems or procedure packsOctober 2018⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2018-3 rev.1Guidance on UDI for systems and procedure packsJune 2020⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2022-11 - rev.1MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR and IVDR requirementsNovember 2023⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2022-18 ADD.1MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate - Addendum 1June 2023⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2022-18MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificateDecember 2022⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2022-14Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDsAugust 2022⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2021-25 rev.1Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EECOctober 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
Official EU legal act
Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 concerning the making available on the market of and use of biocidal products
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation)
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices
Select the citation to open the authentic EUR-Lex version.