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Brexit and the Medical Device Industry

Following the decision for the UK to leave the European Union – referred to as ‘Brexit’ by the media – Advena are prepared, by active leadership from our dual locations, to assist medical device manufacturers wherever they are to practically and efficiently work through any political eventuality that Brexit may inspire.

The UK government are currently negotiating with the EU, however no formal decisions have been made and it will be months before the UK will leave the EU. It is unclear about the acceptance of existing or new EU rules, and how these could fit in with prospective trade agreements, so we must acknowledge that our industry will be going through a period of uncertainly.

Unknowns include:

  • What regulations will UK medical device businesses have to follow after Brexit; the existing EU Medical Device Directives, the new EU medical device regulation and the MEDDEV associated guidance, or something new?
  • The same for cosmetic products; existing EU regulations or something new?
  • How will the UK ensure their own medical device industry is able to compete in the EU if they have no say-so on regulations?
  • Will the medical device industry in the UK need authorised representatives to sell in the remaining EU countries?
  • What will happen to UK based Notified Bodies, will they all need new EU addresses and be accredited from these addresses, or will companies have to change to EU based Notified Bodies?
  • What standards will the EU insist on for products to be CE marked? Will British Standards solely exist to write just UK safety standards?

We are able to assure all clients, existing and new, that Advena Ltd will continue to lead by being a prominent English speaking international medical device consultancy uniquely based in the UK with a subsidiary office in Malta for EU registrations.

In addition, Advena have numerous other global contacts to assure clients continued regulatory conformity around the world, including USA and Australia.

We are ready to lead and work with the national and international medical device industry now and will continue in that role whatever the politicians throw at us.

Here is a report on the latest changes we have reported with respect to Brexit. We will continue to update this page and our blog with the latest developments.

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