There are a few anxieties by U.S. medical device manufacturers concerning the projected exit of Great Britain from the European Union.
1. Does GB allow the U.S. to import devices bearing the CE-Mark?
2. Do Member states within the EU allow imported medical devices having a British Notified Body such as BSI & SGS?
3. Does the British Health care system include reimbursement changes?
4. Does GB generally allow the import of any product from any foreign country?
Let’s focus on these concerns.
The CE-Mark is global, with the exception of the U.S. product approval system, and is not related to the EU. GB will still accept and allow import of any device bearing a CE-Mark.
The Notified Body System is not related to the U.S., and many European countries which are not members of the EU use Notified Bodies (e.g. DNV in Norway). It is very unlikely that the EU would discontinue British NBs for economical reason.
The health care systems in the EU are not harmonized and each member state has their own health care system and reimbursement laws. The British health care system and reimbursement law will not change.
With leaving the EU the import/export agreements need to be renegotiated between the U.S. and GB. This affects all products, not just medical devices. There is a great political history between the U.S. and GB and I strongly believe that the new terms and conditions will be similar to the existing ones.
The EUR and a subsidiary company legally located in Great Britain are no longer valid to legally distribute in the EU. This might have a significant impact on medical device manufacturers in the U.S. In addition, changing the EUR and or moving a legal entity to a member state of the EU labeling changes needs to be completed.
I would like to summarize the evaluation above simply to conclude that Brexit does not have any impact on U.S. medical device manufacturers which do not have a legal entity or EUR in GB. For all manufacturers that do have a legal entity or an EUR in GB, the change is significant.
Devin McElroy, Sr. Director of Technical Engagements at Neozene