Training EU Regulation 2017/745

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)