| 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
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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.