Now That Brexit Has Happened, What’s Next for Medical Device Manufacturers?
UPDATED SEPTEMBER 2, 2020
It was supposed to happen on March 29, 2019, then October 31, 2019. It finally did happen on January 31, 2020. Brexit is done.
NOTE: The UK MHRA released new guidance in September 2020. The information below is updated but this blog post has more complete information.
Here’s what you need to know as a medical device manufacturer:
- The UK is no longer a member of the European Union. FYI the UK includes England, Wales, Scotland and Northern Ireland but not Ireland which is part of the EU.
- The UK MHRA has decided that it will implement its own regulatory scheme for medical devices and will not follow the EU Medical Device Regulation (EU MDR). The MDR takes effect in May 2021.
- Medical device manufacturers that want to pace devices on the UK market after January 1, 2021 will need to register with the MHRA.
- Existing CE Marking certificates issued by Notified Bodies will continue to be recognized until June 30, 2023.
- The UK will be issuing its own UKCA (UK Conformity Assessed) mark to replace CE Marking. CE will not be recognized in the EU after June 2023.
- If your company does not have a presence in the UK and you sell products there, you will need to appoint a “UK Responsible Person” based in the UK. Despite the name, it’s more like a hybrid Importer/EC REP role and can be filled by a person or company.
- Your UK Responsible Person must be the one to register your devices with the MHRA but you will only have 4-12 months to register (depends on device classification). You will not need a separate UK Authorized Representative as required under the EU MDR. If you have not already done so, get busy finding your UK Responsible Person as they will also be responsible for registering your devices with the MHRA.
- If you are shipping goods from the UK to the EU by boat, consider making contingency plans as border controls will go into effect on January 1, 2021 if all goes as planned. That could slow down shipping until the kinks get worked out. Note that this issue has nothing to do with the EU MDR.
Of course, as with everything related to Brexit, things may have changed since the publishing of this article. We advise checking the MHRA website for the latest information. Of course, our team of EU MDR compliance experts is always ready to help you make sense of the changes, ready to help with MDR audit training, or specific MDR consulting solutions.