MDR 2017/745 considers PMCF to be an ongoing process that updates the clinical evaluation and must be addressed in the manufacturer’s post-market surveillance plan (PMS). The MDR reinforces the manufacturer’s PMCF process by dedicating Part B of Annex XIV to it and providing a set of requirements for the development of a plan necessary to implement the PMCF.
Eclevar, a CRO specialized in medical devices, hosts a 45-minute webinar dedicated to the impact of MDR on your PMCF activities.
- Lorraine Houvet, Senior Clinical Operation Manager
- Valérie Longin, Lead Clinical Research Associate
- Dr Max WOITOK, Senior Medical Writer, Eclevar