Essentials of European Medical Device Regulatory Affairs - June 2020

Registration- Devices

UDI Database (Article 27/29)

 Assign Basic UDI  Register Basic UDI with core data elements (annex VI)

Who

Device*

Assign UDI

Register

Manufacturer

Class I Class IIa Class IIb non implantable Class III Class IIb implantable

Before placing on the market

Before placing on the market

Manufacturer

Before conformity assessment

After certificate Before placing on the market Before placing on the market Before placing on the market

System/Procedure packer System/Procedure pack steriliser

Systems and Procedure packs Systems and Procedure packs

Before placing on the market Before placing on the market

*No registration for Custom made devices

TheOrganisation for Professionals in Regulatory Affairs

Registration EOs

EO database (Article 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 timing depends on device class (see previous slide)

 Changes - EO must update within 1 week  Competent Authority can charge a fee

 Routine check will be required to confirm certain data (EO) remains accurate.

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Summary of safety and clinical performance

• For implantable devices and class III. Will be made public via Eudamed • Key information is prescribed in MDR • NB will review • Label or IFU needs to reference the published documents

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