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Unofficial consolidated textConsolidated 2026-01-01English

Annex III

Reproduced from official EUR-Lex 1/1/2026.

TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE

The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 83 to 86 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex.

1.

The post-market surveillance plan drawn up in accordance with Article 84.

The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 83.

  1. (a)

    The post-market surveillance plan shall address the collection and utilization of available information, in particular:

    1. information concerning serious incidents, including information from PSURs, and field safety corrective actions;

    2. records referring to non-serious incidents and data on any undesirable side-effects;

    3. information from trend reporting;

    4. relevant specialist or technical literature, databases and/or registers;

    5. information, including feedbacks and complaints, provided by users, distributors and importers; and

    6. publicly available information about similar medical devices.

  2. (b)

    The post-market surveillance plan shall cover at least:

    1. a proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market;

    2. effective and appropriate methods and processes to assess the collected data;

    3. suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I;

    4. effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field;

    5. methods and protocols to manage the incidents subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;

    6. methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users;

    7. reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84 and 86;

    8. systematic procedures to identify and initiate appropriate measures including corrective actions;

    9. effective tools to trace and identify devices for which corrective actions might be necessary; and

    10. a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.

2.

The PSUR referred to in Article 86 and the post-market surveillance report referred to in Article 85.

Official catalogue · non-binding

Related guidance (21)

Current English catalogue entries that refer to Annex III. Guidance is non-binding and kept separate from the regulation text.

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MDCG 2019-15 rev.1Guidance notes for manufacturers of class I medical devicesDecember 2019
Non-binding guidanceOpen guidance page
Catalogue section
Class I Devices
Published
December 2019
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MDCG 2021-6 - rev.1Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigationDecember 2023
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
December 2023
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  • MDCG 2021-6 - rev.1PDF · Unverified extraction previewOfficial source

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MDCG 2020-13 - Word versionClinical evaluation assessment report templateJuly 2020
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
July 2020
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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
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
April 2020
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  • MDCG 2020-6PDF · Unverified extraction previewOfficial source

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  • Background notePDF · Unverified extraction previewOfficial source

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MDCG 2019-9 - rev.1Summary of safety and clinical performanceMarch 2022
Non-binding guidanceOpen guidance page
Catalogue section
Clinical investigation and evaluation, performance studies and evaluation
Published
March 2022
Topics

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Guidance documentGuidance on regulatory requirements for medical face masksJune 2020
Non-binding guidanceOpen guidance page
Catalogue section
COVID-19
Published
June 2020
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MDCG 2020-9Regulatory requirements for ventilators and related accessoriesApril 2020
Non-binding guidanceOpen guidance page
Catalogue section
COVID-19
Published
April 2020
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  • MDCG 2020-9PDF · Unverified extraction previewOfficial source

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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
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
June 2025
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Show all 21 guidance documentsShow only the first 8
MDCG 2019-16 rev.1Guidance on cybersecurity for medical devicesJuly 2020
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
July 2020
Topics

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  • MDCG 2019-16 rev.1PDF · Unverified extraction previewOfficial source

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MDCG 2019-11 rev.1Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746June 2025
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
June 2025
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  • MDCG 2019-11 rev.1PDF · Unverified extraction previewOfficial source

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MDCG 2024-6Preliminary re-assessment review (PRAR) form template (MDR)May 2024
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
May 2024
Topics

Source document

  • MDCG 2024-6DOCX · Unverified extraction previewOfficial source

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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
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
January 2025
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  • MDCG 2024-7 rev.1DOCX · Unverified extraction previewOfficial source

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  • MDCG 2021-15/MDCG 2024-7 AnnexDOCX · Unverified extraction previewOfficial source

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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
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Catalogue section
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January 2025
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Source documents

  • MDCG 2021-15 rev.1DOCX · 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 2021-15/MDCG 2024-7 AnnexDOCX · Unverified extraction previewOfficial source

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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
Non-binding guidanceOpen guidance page
Catalogue section
Notified bodies
Published
December 2020
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  • MDCG 2020-17PDF · Unverified extraction previewOfficial source

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MDCG 2019-13 rev.1Guidance on sampling of devices for the assessment of the technical documentationDecember 2024
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Catalogue section
Notified bodies
Published
December 2024
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  • MDCG 2019-13 rev.1PDF · Unverified extraction previewOfficial source

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MDCG 2025–10Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devicesDecember 2025
Non-binding guidanceOpen guidance page
Catalogue section
Post-Market Surveillance and Vigilance (PMSV)
Published
December 2025
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  • MDCG 2025–10PDF · Unverified extraction previewOfficial source

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MDCG 2022-21Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745December 2022
Non-binding guidanceOpen guidance page
Catalogue section
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Published
December 2022
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  • MDCG 2022-21PDF · Unverified extraction previewOfficial source

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MDCG 2021-5 rev.1Guidance on standardisation for medical devicesJuly 2024
Non-binding guidanceOpen guidance page
Catalogue section
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Published
July 2024
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  • MDCG 2021-5 rev.1PDF · Unverified extraction previewOfficial source

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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
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Catalogue section
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Published
October 2024
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  • MDCG 2021-25 rev.1PDF · Unverified extraction previewOfficial source

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SCHEER guidelinesUpdate on the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devicescovering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) propertiesJune 2024
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Other guidance documents
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June 2024
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CAMD FAQCAMD MDR/IVDR Transition Subgroup: FAQ – MDR Transitional provisionsJanuary 2018
Non-binding guidanceOpen guidance page
Catalogue section
Other guidance documents
Published
January 2018
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