|Theme||Post-market Clinical Follow-up|
|Target audience||Manufacturers, Notified bodies|
|Products concerned||MD (including Legacy Devices)*|
|Regulatory references||MDR (EU) 2017/745
Annex XIV – Part B
EN – This 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.