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.
Since the UK left the EU on 31st January 2020, negotiations between the UK and the EU are ongoing regarding the future trading agreement between the two. Therefore, we must acknowledge and understand that our industry continues to go through an extremely difficult period of uncertainty.
However, we do have some insight to the details of what will be expected, subject to the details of the future trading relationship of the UK and the EU, these include:
- CE Marking, UK medical device manufacturers must continue to follow the existing EU IVD/Medical Device Directives, the new EU Medical Device Regulations and the MEDDEV associated guidance.
- From 2021 Onwards, UK manufactures selling in the UK, will be required to register all devices regardless of their classification, with the MHRA and follow the UK Medical Device Regulations.
- Non-UK manufactures selling in the UK, will have to follow the UK Medical Device Regulations, appoint an UK Responsible Person for medical devices and have all devices registered with the MHRA regardless of classification to ensure UK market access.
- UK based medical device manufacturers will be required to appoint an EU Authorised Representative (EC REP) based in the EU, such as Advena Ltd., Malta, to ensure they can continue to sell in the remaining EU countries.
- UK based Notified Bodies, will cease to act as such and will either relocate or set-up a new Notified Body in the EU as BSI have. In many cases companies will need to change to EU based Notified Bodies.
We can 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 for UK registration and 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 the way and work with national and international medical device industry and regulatory authorities and are prepared to adapt to the changing political and regulatory landscape.
Our news pages will keep you up to date with regulatory and Brexit related information please click here for the latest developments.