UK Recognises extended CE Certificates

The UK Government has taken steps towards recognizing extended CE Certificates in light of the recent EU amendment to the MDR and IVDR transitional periods. On 28 March, 2023, the Government announced that the above-mentioned alterations would also be recognised in the GB market. The UK  MHRA registration guidance will further reflect these changes.

Essential information about the EU’s extension

 

The EU transitional period prolongation will affect devices based on their risk class:

 

– An extension of the transitional period until 31 December 2027, for:

  • Class III
  • Class IIb implantable devices (exceptsutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors).

– An extension for the transitional period until 31 December 2028, for:

  • Class IIb non-implantable devices;
  • Class IIa devices;
  • Class I with measuring function;
  • Class I sterile devices;
  • Class I devices needing the involvement of Notified Bodies under MDR (up-classified devices);

 

In this sense, the EU will extend the validity of CE Certificates issued by notified bodies until the end of the new transitional periods:

  • Certificates that have expired before March 20, 2023, will be subject to meeting the conditions set out in the amendments to EU MDR, which are to:
    • Have a written agreement between the manufacturer and Notified body; OR
    • Be granted a derogation from a Competent Authority as per Articles 59 or 97 MDR (while transitioning to MDR certification).
  • Certificates expiring after March 20, 2023, will be considered valid until the end of their relevant transition period according to their device class (2027 or 2028).

As per the Northern Ireland Protocol these extended periods will apply automatically to Northern Ireland. Furthermore, the recognition of extended CE Certificates applies to CE-marked devices placed on the GB market.

How can you profit from this extended period?

There are plenty of ways in which Obelis can assist manufacturers to benefit from the new timelines, such as:

  1. We can ensure your devices meet the extended transitional period’s requirements.

 

  1. We can register your products with the MHRA until the new transition timeline.

 

  1. The transition period extension will allow manufacturers to place their devices on the GB market swiftly and for a prolonged time. In the meantime, Obelis can help them select and negotiate with approved bodies to ensure that the UKCA mark will be acquired before the end of the transitional period.

 

Are you a manufacturer of medical devices which would like to get further information on the CE certificate extension? Contact Obelis today and we will gladly assist you.

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Check Obelis UK News page to keep up to date with the latest Medical Devices and Cosmetics market in the UK.

Isabella Ana Cazan

Regulatory Affairs Department

04/04/2023

Would you like to place medical devices on the UK market? Contact us and we will guide you through the process!

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References:  

The information contained on Obelis UK is presented for general information purposes only, without obligation and it has been compiled with the utmost care to ensure it remains up to date. Nevertheless, Obelis Group cannot be held liable for the accuracy and completeness of the information published. Any reliance placed on such information is therefore strictly at the User’s risk.

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