Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime of the device concerned, that PSUR shall set out:
the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.
Manufacturers of class IIb and class III devices shall update the PSUR at least annually. That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II and III.
Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years. That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II and III.
For class III devices or implantable devices, manufacturers shall submit PSURs by means of the electronic system referred to in Article 92 to the notified body involved in the conformity assessment in accordance with Article 52. The notified body shall review the report and add its evaluation to that electronic system with details of any action taken. Such PSURs and the evaluation by the notified body shall be made available to competent authorities through that electronic system.
3.
For devices other than those referred to in paragraph 2, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities.
Official catalogue · non-binding
Related guidance (15)
Current English catalogue entries that refer to Article 86. Guidance is non-binding and kept separate from the regulation text.
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MDCG 2024-10Clinical evaluation of orphan medical devicesJune 2024⌄
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MDCG 2019-9 - rev.1Summary of safety and clinical performanceMarch 2022⌄
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MDCG 2021-3Questions and Answers on Custom-Made DevicesMarch 2021⌄
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MDCG 2021-1 rev.1Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functionalMay 2021⌄
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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⌄
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MDCG 2019-16 rev.1Guidance on cybersecurity for medical devicesJuly 2020⌄
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MDCG 2024-6Preliminary re-assessment review (PRAR) form template (MDR)May 2024⌄
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Show all 15 guidance documentsShow only the first 8
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⌄
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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⌄
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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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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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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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MDCG 2022-21Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745December 2022⌄
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