Module 15 Presentations

10/04/2024

Notified body expectations

• The PMCF plan can be part of the PMS plan if all PMCF requirements are met • The manufacturer follows all relevant guidance (see next slide) • There is an unwritten assumption that literature searches, a general method of PMCF will always be carried out • If PMCF investigations, a specific method of PMCF, are not carried out a justification will be provided • A PMS and PMCF plan will always be needed for each medical device, combined plans may be accepted if duly justified • The manufacturer is responsible for submitting PSURs and ensuring they are assessed by the Notified Body • The PSUR is a true and accurate account confirming the ongoing performance and safety of the device

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

31

Relevant Guidance

• MDCG 2024-1 Device Specific Vigilance (DSVG) Template (See also DSVG 01, 02, 03, and 04) • MDCG 2023-7 Guidance 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 equivalence, December 2023 • MDCG 2020-3 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices, February 2023 • MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745, December 2022 • MDCG 2021-1 Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional, May 2021 • MDCG 2020-7 Guidance on PMCF plan template, April 2020 • MDCG 2020-8 Guidance on PMCF evaluation report template, April 2020

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

32