UK recognises extended CE Certificates

The UK is taking new steps to recognise the extended CE Certificates in light of the recent amendment of the MDR and IVDR transitional periods. In its press release, the UK Government indicates that these changes (which automatically apply in Northern Ireland) will also be recognised in the Great Britain market.

To which devices does this extension apply?

The EU extension sets different transitional periods depending on the risk class of the device:

  • Class III and specific Class IIb devices (except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) need to comply with EU MDR requirements by 31 December 2027
  • Class IIb devices not covered in the previous point, Class IIa devices and Class I (sterile, with a measuring function or needing the involvement of a Notified Body) need to comply with EU MDR requirements by 31 December 2028

All EU CE Certificates’ validity is extended until the dates above. Nevertheless, a distinction has to be made depending on the expiration date of the certificate:

  • Manufacturers of certificates that have expired before 20 March 2023 are required to:
    • Have a written agreement between the manufacturer and the notified body (NB) before the Certificate expires
    • Receive a derogation (” authorisation”) from a Competent Authority by following either Art. 59 or Art. 97 MDR (while transitioning to MDR certification)
  • Certificates expired after 19 March 2023 will be valid until the end of the relevant transitional period. 

Lastly, it’s important to note that this UK recognition on the CE Certificate’s extension only applies to products placed on the GB market with the CE mark. Further updates on the registration guidance will be implemented. 

You can find all relevant documents in our Library of Documents

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