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

Article 61

Annex XIV – Part B



ENThis guide provides a detailed evaluation report template of Post market clinical follow-up (PMCF). This report shall be part of the clinical evaluation report and the technical documentation.

* 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.