Theme Post-Market Clinical Follow-up
Target audience Manufacturers, Notified bodies
Product concerned MD (including Legacy Devices)*
Regulatory references MDR (EU) 2017/745

Article 61

Annex XIV – Part B



ENThis guide provides a detailed template for the Post Market clinical Follow-up (PMCF) plan.

* Note : the term « legacy devices » identifies Medical Devices that are covered by a valid certificate issued in accordance with a Directive and that continues to be placed on the market after the date of application of the Regulation.