The Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on GOV.UK, which sets out how medical devices and IVDs will be regulated after the transition period with the EU has ended (from 1 January 2021).The MHRA has stated that this guidance will apply irrespective of whether a trade deal is agreed with the EU or not.
Current UK-based EU notified bodies, such as BSI UK 0086, will become UK Approved Bodies (UKAB) and their scope of designations under the EU legislation will automatically roll over on the 1 January 2021. BSI UK will retain its identification number, 0086.
We want to clarify a few other aspects for those who have CE certificates or CE applications with our UK Notified Body BSI 0086. If you hold CE certification with BSI NL (BSI 2797), the information below does not apply to you.
Ongoing applications for initial CE certification, changes to issued CE certificates and renewal of CE certificates
1. If the certification process is completed by the end of 2020, a CE certificate will be issued/re-issued.
a. Initial approvals or renewals of certificates will have an expiry date of 26 May 2024. For changes to issued certificates, the current expiry date will be retained.
b. The CE certificate will continue to be valid for placing devices on the market in Great Britain (GB) after the 1 January 2021. It will not be valid for placing devices on the EU market.
c. Any subsequent change or renewal of your CE certificate after 1 January 2021 will be processed as a United Kingdom Conformity Assessed (UKCA) certificate. At this stage, the certificate prefix will change from CE to UKCA (for example, CE XXXXXX will become UKCA XXXXXX). If no such changes are processed and you wish to maintain access to the GB market, the certificate must be re-issued as a UKCA certificate by the 1 July 2023 for the rest of its validity period.
d. At the time of conversion of the certificate from a CE certificate to a UKCA certificate, manufacturers will be expected to provide copies of draft UKCA labelling and a revised draft declaration of conformity with references to the UK legislation and reference to BSI (0086) as the UK Approved Body. You will be required to provide evidence of the appointment of a UK Responsible Person (UKRP) if the manufacturer is based outside the UK. Manufacturers should have a documented labelling transition plan (for a maximum period of six months) – the implementation of which will be verified during subsequent BSI surveillance audits.
2. If the certification process is completed on or after the 1 January 2021, a UKCA certificate will be issued/re-issued.
a. To support the issue of a UKCA certificate, manufacturers will be required to provide all the items specified in point 1.d above, prior to certification.
b. Initial approvals or renewals of certificates will have full five-year validity. For changes to issued certificates, the current expiry date will be retained.
c. The UKCA certificate will be valid for placing devices on the GB market after the 1 January 2021. It will not be valid for placing devices on the EU market.
For manufacturers with existing certification, there will be no changes to your current surveillance cycle and audit activities will be maintained after 01 Jan 2021.
Terms and Conditions of Contract
Although MHRA has issued guidance on the future UK legislation, the updated UK medical device legislation itself is not published as of the date of this communication. Once published, BSI will confirm terms and conditions in January 2021. We remain confident that, as the only notified body with full scope designation to the new UKCA, we will be able to support your future growth.
Who can I contact for further information?
If you have questions or concerns, please refer to our website in the first instance where we maintain up to date information on Brexit and UKCA certification. Further information can be provided via your BSI Scheme Manager if needed.
Dr Jayanth Katta
Head of UK Approved Body, Regulatory Services