Following ratification of the exit agreement by the European Union and the United Kingdom, the United Kingdom left the European Union on February 1, 2020.
Currently the AIMDD, MDD and IVD are applied in the UK. These directives will remain in force after the transitional period and are transposed into UK law by the UK MDR 2002. The MDR and IVDR, however, will become applicable in the EU after the transitional period (May 2021 and May 2022) but will not automatically apply in the UK at that time. A draft amendment published in 2019 related to the MDR 2002 describes the intended regulatory system for medical devices and IVDs in the UK after January 1, 2021.
From January 1, 2021, all medical device placed on the UK market must be registered with the MHRA. This requires that manufacturers located outside the UK need to designate a responsible person (UK REP) located in the UK. This person will then assume responsibility and tasks in the United Kingdom similar to those of the European Authorized Representative (EAR) in Europe.
Depending on further developments and decisions, in particular the role of the UK responsible person, MT Promedt will provide the regulatory services of an UK REP via our UK office in Oxford from January 2021.
MT Promedt Consulting offers a complete consultancy service for medical device manufacturers. Your business is our business. So whether you need first ideas or a second opinion: we’re here to listen – and ready to answer.