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MDCG releases post-market clinical follow-up plan and evaluation report forms

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Published on: 28 April 2020

Published by LNB News

LNB News 28/04/2020

Document Information

Issue Date: 28 April 2020

Published Date: 28 April 2020

Jurisdiction(s): United Kingdom

Article summary

The Medical Device Coordination Group (MDCG) has published two templates with guidance to assist manufacturers and notified bodies in the planning and completion of a post-market clinical follow-up (PMCF) evaluation report conducted for medical devices after being placed on the market to ensure their continued safety and quality. This comes in preparation for the application of the new medical devices regime, Regulation (EU) 2017/745, the Medical Device Regulation (MDR), now postponed to 26 May 2021.

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