Brexit Transition Consulting and In-Country Representation for Medical Device and IVD Companies
ANSWERED ON THIS PAGE:
- When will the UK leave the European Union?
- Do European companies need in-country representation in the UK?
- How can medical device companies prepare for Brexit?
The UK intends to withdraw from the European Union on 29 March 2019, also known as “Brexit Day.” While a transition period is intended, medical device companies should prepare for a situation in which there is no transition period (i.e., a “cliff edge” or “no deal” Brexit). Note that Brexit day may be delayed and it is even plausible the UK decides to cancel Brexit entirely.
Brexit will have an immediate effect on medical device companies that wish to sell across the Channel, particularly regarding in-country representation. With offices in the UK and The Netherlands, Emergo can help you establish in-country representation and maintain compliance in both markets.
Medical device in-country representation (UK Responsible Person) in post-Brexit United Kingdom
The Medicines & Healthcare products Regulatory Agency (MHRA) published a revised guidance document indicating that CE marked devices will be recognized in the UK and emphasizing their commitment to the MDR/IVDR, irrespective of the outcome of Brexit. With “no deal” Brexit, the legislation promulgated “will mirror all key elements” in the MDR/IVDR. The guidance specifies that in the “no deal” Brexit environment, the representative in the UK will be termed UK Responsible Person.
Medical device authorized representation (EC Rep) in post-Brexit European Union
EU-based manufacturers distributing their devices in the remaining Member States (EU27) will require a UK Responsible Person to distribute their devices in the UK. Non-EU manufacturers using an EU27-based AR will require a UK Responsible Person to distribute their devices in the UK. Non-EU manufacturers using a UK-based authorized representative (AR) will need to appoint a new EU27-based AR (and retain their existing UK representative as the UK Responsible Person).
Emergo provides in-country representation in the UK and EU
Emergo is uniquely positioned to help you navigate regulatory compliance through Brexit. Whether a transition period follows the UK’s withdrawal or not, you can establish representation in the UK and the EU through our offices in Cambridge, UK and The Hague, Netherlands. Here’s how we can help:
- For UK-based companies, we can act as your EC Rep.
- For EU-based companies, we can act as your UK Representative, if needed.
- Unique delayed-start option: secure representation in the UK or EU and activate service upon UK withdrawal according to terms of the Brexit agreement.
- Perform a completeness review of key components of your Technical File and review your draft labeling.
Emergo is one of the largest European Authorized Representatives for medical device and IVD manufacturers, representing hundreds of companies worldwide. Contact us to learn more about Brexit transition and representation services.