With only 8 weeks remaining, European authorities are finalizing preparations for the withdrawal of the United Kingdom from the European Union. Considering the approaching deadline, the European Commission has published its 6th Brexit preparedness communication. The European Commission sends a strong message to all stakeholders including those in the medical device industry to prepare for a no-deal Brexit.
As remains the case, only those manufacturers complying with EU rules will be able to place their medical devices on the EU market after the UK exit day. The European Commission can conclude today that a vast part of the manufacturers has transferred their medical device certificates from UK notified bodies to a EU27 notified body. Without a deal, UK notified body certificates will become void after the withdrawal date. Remaining manufacturers are therefore recommended to relocate their certification to a notified body in one of the EU27 countries and make the corresponding adjustments to product labels.
Like EU authorities, UK authorities are making the necessary preparations for a no-deal Brexit. The UK’s guidance regulating medical devices in case of a no-deal scenario clarifies, among others, the role of the MHRA, the applicable UK medical device legislation and the registration requirements. To ensure the supply of medical devices, UK authorities will continue to recognize the validity of CE certification by UK notified bodies achieved prior to Brexit. In the same line of thought, the UK will continue to grant access to medical devices in conformity with EU rules during a limited period after their withdrawal.
Contact us to guarantee your EU and UK compliance after Brexit. Obelis consultants are available for support.