After the United Kingdom’s vote to leave the European Union, uncertainty has become the norm. Erik Vollebregt, a founding partner of life sciences law firm Axon (Amsterdam), writes on his medicaldeviceslegal website that medical device companies are asking him “what this means for CE marks for medical devices and for the process of the [new medical device and in vitro diagnostics regulations] as well as medical device law and policy in the EU, in general.”
It’s unlikely that the so-called Brexit will have any impact on the new medical device and in vitro diagnostics regulations (expected to be adopted by the European Council and Parliament this year). “The EU will certainly not suspend the project because of the Brexit because the texts were established following the normal legislative procedure. The texts will enter into force in the EU as planned and may also take effect even in the UK, up until the date on when the UK formally disengages from EU law,” writes Vollebregt.
The United Kingdom still has to trigger Article 50 of the Lisbon Treaty, formally starting the process of withdrawal from the European Union. Until that happens, nothing changes. Even when the UK government pulls the trigger, “the law calls for a two-year process, and the adoption of the new medical device and IVD regulations will be well underway at that point.”
The main question across the globe is what type of relationship the United Kingdom will have with the European Union after it pulls out: one possible outcome is the signing of a mutual recognition agreement along the lines of the treaty that Switzerland has with the EU. “That agreement allows Switzerland to have notified bodies and provides for mutual recognition of the CE mark,” notes Vollebregt.
For the time being, until the final breakup, “British legislation remains fully aligned with European rules and CE marked products can move freely across the Channel.”
No one really knows where this uncertainty is heading – causing a lot of headaches throughout the global manufacturing, business and financial communities.