Module 5 Presentations

16/07/2024

Introductions

Mariona

Neil

•

•

The Organisation for Professionals in Regulatory Affairs

3

Reminder: Medical Device Regulation

MD CG

European Commission

Agency (eg EMA)

MS-CA Competent Authority

Team NB EUAR

EU-NB Notified Bodies

Manufacturer

∆Supply Chain

CT Rep

User

Patients

Ethics Ctte

The Organisation for Professionals in Regulatory Affairs

4