Following the official announcement on Friday 31 January 2020 that the UK has officially ceased to be a member of the European Union, we want to clarify what the impact is for CE Certificates issued by our UK Notified Body (0086).
The UK has now entered a transition period in which it will negotiate future business and trade agreements with the EU. The Medicines and Healthcare products Regulatory Agency (MHRA) recently confirmed that, during this transition period, the UK will stay aligned to EU law. The transition period is due to end on Thursday 31 December 2020.
What does this mean for medical device manufacturers?
Effectively, during the transition period, everything remains as before:
- CE Certificates issued by our UK Notified Body (0086) continue to be valid for both EU and UK markets
- BSI UK Notified Body can continue to conduct conformity assessments for medical devices being placed on the EU and UK markets
- UK-based manufacturers do not require an EU Authorized Representative based in an EU member state to place their medical devices on the EU market
- Existing EU Authorized Representatives based in the UK are unaffected and can continue to operate as before until the end of the transition period.
We will continue to inform you of any changes, which might affect applications for CE marking of your medical devices or the validity of the certificates we may have already issued, and encourage you to visit our website regularly for the latest information.
For any queries, please e-mail meddev.enquiries@bsigroup.com
