Training EU Regulation 2017/745
- Bertrand Dohm
- Jun 19, 2023
- 1 min read
The programme in brief :
1. European Regulation EU-2017/745
o Origin and principles of medical device regulation
o Legislative developments and timetables
o The new ‘product’ scope and classification criteria
o The status of economic operators and their new responsibilities
2. CE marking
o Conformity assessment procedures
o The new general performance and safety requirements
o Focus on clinical evaluation
o Traceability and information - patient information - UDI and Eudamed
o QMS requirements
3. Surveillance requirements
o Post-marketing surveillance (PMS)
o Post-Market Clinical Monitoring (PMCF)
o Materials vigilance
o Periodic Safety Report (PSUR)
Comments