Brexit Implications for Medical Device Manufacturers
Britain decided to leave the European Union on the 23rd of June 2016 following a national referendum.
The main non-economic impact on medical device manufacturers in the UK is compliance with current European legislation on medical devices. There is no doubt that to sell medical devices to customers in one of the 27 member states of the EU or the 4 EFTA countries (Switzerland, Norway, Iceland & Lichtenstein) that the products will need to comply with the new European Medical Device Regulations (still in draft).
The question is, will the UK be treated like a non EEA member in which case UK manufacturers would require a European Authorised Representative (EAR) to sell into the EU or will we be able to become an EFTA (European Free Trade Agreement) member along with Switzerland, Norway, Iceland & Lichtenstein. Appointing an EAR will undoubtedly have a cost and a logistics impact for manufacturers. However the suggestion from Brussels is that free trade with Europe (EFTA membership) goes hand in hand with free movement of people, a position that might be politically difficult to reconcile.
These seem to be two most likely options available to access the European market.
We won’t know the answer to this question until clause 50 of the Lisbon treaty is activated and the future arrangements for a relationship are negotiated.
See extract from article 50 below:
“A Member State which decides to withdraw shall notify the European Council of its intention. In the light of the guidelines provided by the European Council, the Union shall negotiate and conclude an agreement with that State, setting out the arrangements for its withdrawal, taking account of the framework for its future relationship with the Union. That agreement shall be negotiated in accordance with Article 218(3) of the Treaty on the Functioning of the European Union. It shall be concluded on behalf of the Union by the Council, acting by a qualified majority, after obtaining the consent of the European Parliament.”
The requirements of Medical Devices Manufacturers will be considered along with all other UK based manufacturers and service providers to conclude a deal that will allow us access to our biggest market.
QCS will continue to keep you updated through our Newsletters & Blogs throughout 2017.
