Following the 2016 controversial referendum, as of March 30, 2019, European laws will no longer be applicable in the United Kingdom. A European Commission notification informs stakeholders on the changes about to affect the medical industry.

MD and IVD manufacturers and importers based in the UK will be considered as third country entities for EU countries. Similarly, economic operators based in the European Union will become third countries importers on the British market.

All European Authorized Representatives currently based in the United Kingdom (50% of the market) will no longer be recognized after Brexit. Foreign manufacturers shall therefore appoint a new Authorized Representative based in any of the EU-27 countries.

Another heavy consequence affects the British Notified Bodies, who will no longer be considered as part of the EU and will no longer issue EC conformity certificates.

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