Module 16 2024

21/10/2024

PMS under the MDR – inter-related processes

Registers / Databases / literature

Information about similar devices

Studies

CER

PMCF

Trend reporting

PMS

PMCF Plan

Clinical Evaluation

Feedbacks and complaints from users

PMCF evaluation report

Vigilance

SSCP Class III/implantibles

PSUR/PMS report

Risk Management

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PMS – Notified Body Expectations under Article 120 (3)

Due to the various extensions to the MDR, some devices could still be considered “legacy devices” until December 2028. • “However, the requirements of this Regulation relating to post -market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.”

• PMS requirements must be met from 26 th May 2021:

- Article 83, Post-market surveillance system of the manufacturer

- Article 84, Post-market surveillance plan

- Article 85, Post-market surveillance report

- Article 86, Periodic safety update report

• PMS “legacy package” for May 2022

- PMS plan

- PMCF strategy (recommended but not to be submitted to Notified Body for review)

- PMCF plan (MDCG 2020-7) / justification for not performing PMCF

Annex III

- PMCF evaluation report (MDCG 2020-8)

- PMS Report/Periodic Safety Update Report (PMSR/PSUR)

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