Helsinki ProcedurePDF · Unverified extraction previewOfficial source
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MDCG 2025-5Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746June 2025⌄
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MDCG 2021-21 rev.1Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devicesFebruary 2022⌄
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MDCG 2022-1Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devicesJanuary 2022⌄
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MDCG 2021-7Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devicesMay 2021⌄
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Guidance documentCOVID-19 TESTS: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19 (available in all EU languages and Arabic , Chinese , Japanese , Russian )February 2021⌄
COVID-19 TESTS: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19PDF · Unverified extraction previewOfficial source
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Guidance documentGuidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 contextApril 2020⌄
Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 contextPDF · Unverified extraction previewOfficial source
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Gradual roll out of EUDAMEDQ&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices1November 2024⌄
Gradual roll out of EUDAMEDPDF · Unverified extraction previewOfficial source
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Show all 43 guidance documentsShow only the first 8
MDCG 2022-12Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)July 2022⌄
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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⌄
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MDCG 2024-16Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devicesDecember 2024⌄
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MDCG 2024-11Guidance on qualification of in vitro diagnostic medical devicesOctober 2024⌄
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MDCG 2024-4 MDCG 2024-4 AppendixSafety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746Appendix – Performance Study Summary Safety Reporting FormApril 2024⌄
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MDCG 2022-9 rev.1Summary of safety and performance templateApril 2024⌄
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MDCG 2020-16 rev.4Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746March 2025⌄
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MDCG 2022-20Substantial modification of performance study under Regulation (EU) 2017/746December 2022⌄
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MDCG 2022-19Performance study application/notification documents under Regulation (EU) 2017/746December 2022⌄
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MDCG 2022-15Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDDSeptember 2022⌄
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MDCG 2021-22 rev.1Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746September 2022⌄
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MDCG 2022-10Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)May 2022⌄
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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⌄
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MDCG 2022-6Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDRMay 2022⌄
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MDCG 2022-3 rev.1Verification of manufactured class D IVDs by notified bodiesDecember 2024⌄
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MDCG 2022-2Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)January 2022⌄
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MDCG 2021-4 rev.1Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746September 2024⌄
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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⌄
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MDCG 2020-1Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device softwareMarch 2020⌄
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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⌄
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MDCG 2024-9Preliminary re-assessment review (PRAR) form template (IVDR)May 2024⌄
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MDCG 2023-2 MDCG 2023-2 MDR form MDCG 2023-2 IVDR formList of Standard FeesJanuary 2023⌄
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MDCG 2021-18Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)July 2021⌄
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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⌄
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MDCG 2021-14Explanatory note on IVDR codesJuly 2021⌄
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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⌄
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NBOG F 2017-8Review of qualification for the authorisation of personnel (IVDR)February 2018⌄
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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⌄
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MDCG 2025–10Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devicesDecember 2025⌄
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Q&AQ&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860July 2024⌄
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MDCG 2022-11 - rev.1MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR and IVDR requirementsNovember 2023⌄
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MDCG 2022-14Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDsAugust 2022⌄
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MDR/IVDR Language requirementsOverview of language requirements for manufacturers of medical devices for the information and instructions that accompany a device in a specific countryJanuary 2024⌄
MDR/IVDR Language requirementsHTML · Unverified extraction previewOfficial source
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European Medicines Agency (EMA) GuidanceQuestions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)June 2021⌄
European Medicines Agency (EMA) GuidanceHTML · Unverified extraction previewOfficial source
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