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.
Negotiations between the UK and the EU are ongoing; however, the most likely outcome now appears to be, the UK will leave the EU on or before the 31st October 2019 without a deal and with no formal agreement regarding the future trading agreement between the two. Therefore, we must acknowledge and understand that our industry is going through an extremely difficult period of uncertainty.
However, we do now know some details of what will be expected, subject to Brexit, these include:
- To CE mark, 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.
- UK manufactures will be required to register all devices regardless of their classification, with the MHRA and follow the UK Medical Device Regulations.
- Non-UK manufactures 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 access to the UK market.
- UK based medical device manufacturers will be required to appoint an EU Authorised Representative based in the EU, 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 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 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 and work with the national and international medical device industry now and will continue in that role whatever the politicians throw at us.