Essentials of European Medical Device Regulatory Affairs - October 2019
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 0000
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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
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