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:
- We can ensure your devices meet the extended transitional period’s requirements.
- We can register your products with the MHRA until the new transition timeline.
- 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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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!
References:
- EUR-Lex. (20 March 2023). Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. Retrieved on 29/03/2023.UK Government. (29 March 2023). Extension of CE certificates – GOV.UK (www.gov.uk) Retrieved on 29/03/2023.
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