Essentials of European Medical Device Regulatory Affairs

Affix the CE mark and place on the EC market

• All devices must bear the CE mark except: • Custom made devices • Investigational devices • Affixed to the device or the sterile packaging or the packaging (if not applicable/possible) • Must appear in any instructions for use and any sales packaging • shall be accompanied by the NB number (where applicable) (check NB rules on their logo) • Form of the CE mark per Annex V xxxx

The Organisationfor Professionals inRegulatory Affairs

Registration- Devices UDI Database (Article 29)  Assign Basic UDI  Register Basic UDI with core data elements (annex VI)

Who

Device* Class I Class IIa

Assign UDI

Register

Manufacturer

Before placing on the market

Before placing on the market

Class IIb non implantable

Manufacturer

Class III Class IIb implantable

Before conformity assessment

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

System/Procedure packer Systems and Procedure packs

Before placing on the market Before placing on the market

System/Procedure pack steriliser

Systems and Procedure packs

*No registration for Custom made devices

The Organisationfor Professionals inRegulatory Affairs