| 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
|
EN – This 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.