The United Kingdom is expected to have a revised UK Medical Devices Regulation (MDR) applicable from July 2025. Until then, the primary goal is to ensure system readiness and reduce the risk of supply interruption for UK patients. To that end, the UK government confirmed publicly that, subject to Parliamentary approval, CE-marked medical devices will be allowed on the market in Great Britain after the current deadline of 30 June 2023.
UK to align with the new EU transitional period
The UK will align with the latest EU extensions to offer manufacturers additional time to sell specific medical devices authorised under the EU Medical Devices Regulation 2017/745 by the following deadlines:
- 30 June 2028 or up until the expiry date of the certificate for EU MDD 93/42/EEC compliant general medical devices or EU AIMDD 90/385/EEC compliant devices;
- 30 June 2030 or up until the expiry date of the certificate for EU IVDD 98/79/EC compliant devices;
- 30 June 2030 or up until the expiry date of the certificate for EU IVDR 2017/746 and MDR 2017/745 compliant general medical devices, including custom-made devices.
What to do when the CE certificate has expired
Manufacturers will only be allowed to rely on expired certificates when placing medical devices on the GB market under these transitional arrangements if such certificates have been considered valid by the EU:
- If the certificate expired before 26 May 2021, extension is not possible, and devices must be MDR compliant.
- If certificate expired between 26 May 2021 and 20 March 2023, extension is not possible IF the manufacturer did not sign an agreement with the NB before the expiration date of the certificate and did not obtain Art. 59/Art. 97 derogation before 20 March 2023 and devices must be MDR compliant.
- If certificate expired between 26 May 2021 and 20 March 2023, extension is automatic IF the manufacturer did sign an agreement with the NB before the expiration date of the certificate and did obtain Art. 59/Art. 97 derogation before 20 March 2023.
- For class I devices under MDD (non-sterile, non-measuring) that are up-classified under MDR (reusable surgical instruments, class IIa, IIb, III), extension is automatic until 31 December 2028.
MHRA requires an additional self-declaration in case the certificate is considered valid until or after 20 March 2023 according to Article 120 of the EU MDR.
CE Certificate extension applicable in the UK
The Medicines & Healthcare products Regulatory Agency (MHRA) explains the impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU in a recently issued guidance. Once the future medical device regulation is in place, manufacturers will not be able to rely on EU MDR or EU IVDR CE certificates that are renewed after the future system fully applies (1 July 2025) for placing medical devices on the Great Britain market. As your UK Responsible Person, Obelis will act based on your specific case, smoothening your access to the European markets.
Advantages for manufacturers selling in the EU
The decision of the UK government to align with the latest extensions in the EU positively impact manufacturers of medical devices and IVD medical devices. Manufacturers can now comply with the EU legislation and easily access the UK market for a longer period of time. Although the United Kingdom has different regulations for medical devices, reaching UK compliance is a fast process if the devices are EU compliant.
As UK RP, Obelis guides manufacturers towards the UK market and ensures they are UK compliant when the respective deadlines are approaching. As of now, manufacturers are suggested to act and:
- Appoint a UK Responsible Person
- Ensure compliance with the latest EU requirements to sell both in the EU and UK
- Start transitioning towards the UK MDR
Mihaela Idu
Regulatory Affairs Department
15.05.2023
Do you need assistance entering the UK market using the CE or UKCA marking? Contact us today!
References:
- Gov.uk (2023) Medical devices – extended acceptance of CE marked medical devices on the Great Britain market. Retrieved on 15/05/2023.
- Gov.uk (2023) Implementation of the Future Regulations. Retrieved on 15/05/2023.
- Gov.uk (2022) Consultation on the future regulation of medical devices in the United Kingdom. Retrieved on 15/05/2023.
- Gov.uk (2023) Extension of CE certificates. Retrieved on 15/05/2023.
- Gov.uk (2023) Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU. Retrieved on 15/05/2023.
- Gov.uk (2023). Register medical devices to place on the UK market. Retrieved on 15/05/2023.
- Obelis (2023). New legacy period for medical devices. Retrieved on 15/05/2023.
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.