UK Responsible Person
It is looking more likely than ever that the UK will leave the European Union on the 31st October 2019 therefore the contingency legislation released by the UK government, The Medical Devices (Amendment etc.) (EU exit) Regulations 2019 which includes the requirement for all non-UK manufacturers to designate a UK based UK Responsible Person, will come into force from exit day.
The UK Responsible Person’s responsibilities are to act on behalf of the manufacturer to ensure all their responsibilities detailed within the amended UK MDR 2002 regulations are met. These include amongst other tasks to register devices prior to being placed on the UK market. Details regarding registering devices, can be found on our blog.
As a team of dedicated medical device regulatory professionals, Advena Ltd can offer a UK Responsible Person Service from our registered offices in the UK. We can assure all clients new and existing that our services will meet the demands of the changes inflicted on you following Brexit. We as always 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. Clients will also receive regulatory news reports by email which we understand have been regarded as an invaluable means to keep up-to-date with the ever-changing regulations and standards.
Be ahead of the game and prepare now.