Module 16 2024

10/17/2024

Summary and Learning Outcome

 MDR PMS Requirements are applicable to all medical devices from May 26, 2021 on!

 MDR PMS Requirements are more explicit and prescriptive as compared to the former Directives, but also give more details about what to implement and how to document and report when and with what content.

 Post- Market Surveillance is a continuous Life-Cycle Approach.

 PMS is a data driven approach and requires structure and resources for good data.

 MDR PMS has a significant impact on Risk Management, Clinical Evaluation and Technical Documentation for maintaining the CE-Marking .

 New and different PMS Technical Documentation and Reporting Requirements!

 Greater involvement of Economic Operators , Notified Bodies and Competent Authorities

 However, there are good Guidance documents available to assist implementing a robust EU-MDR PMS System.

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

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References

• 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

• MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 (MDR)

• MDCG 2021-25 Regulation (EU) 2017/745 - application 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/EEC

• MDCG 2020-8 Guidance on PMCF evaluation report template

• MDCG 2020-7 Guidance on PMCF plan template

• MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD

• ISO/TR 20416:2020 Medical devices — Post-market surveillance for manufacturers

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