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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