Essentials of European Medical Device Regulatory Affairs

Registration Economic Operators EO database (Article 30 & 31):

For manufacturers, authorized representatives and importers: • EOs Submit information per Section 1 of Annex VI Part A • Competent Authority verifies data and issues Single Registration Number (SRN) • Registration before placing the device on the market • For Class III and Class IIb implantable devices SRN

must be obtained prior to NB assessment • Changes - EO must update within 1 week • Competent Authority can charge a fee

The Organisationfor Professionals inRegulatory Affairs

Module 5

• Clinical evaluation • Equivalence requirements • Clinical investigations

The Organisationfor Professionals inRegulatory Affairs