Module 16 2022

9/2/2022

The Inter Related Processes for PMS

PMS under the MDR

Registers / Databases

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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Notified Body Expectations

PMS – Notified Body Expectations under Article 120 (3)

• “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) - PMCF plan (MDCG 2020-7) / justification for not performing PMCF - PMCF evaluation report (MDCG 2020-8) - PMS Report/Periodic Safety Update Report (PMSR/PSUR)

Annex III

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