Two documents recently published by the Government provide some further context on what Brexit and any Transition Period means for business.
Until the end of implementation period, currently set for 31 December 2020, market access for medical devices and its processes will remain unchanged. Consequently, during the transition period, there will be no need to establish an authorised representative in the EU by the UK businesses; CE marking will still be recognised in both the UK and EU markets. The notified bodies in the UK are to continue conducting third-party conformity assessments, which are also to be recognised within the EU.
UK’s plans for releasing guidance in relation to the Medical Devices Regulation
(This point is not applicable to the veterinary sector)
We cannot pre-judge the outcome of negotiations which will inform what the future arrangements will be, however, the UK has been central to agreeing the new legislation and we are supportive of its aims to strengthen the regulatory system and increase the transparency of information about products on the EU market.
The EU Medical Devices Regulation will be fully applied from May 2020, during the implementation period agreed with the EU. This would not automatically follow for the new EU Regulations for in vitro diagnostic (IVD) medical devices, which does not apply until May 2022.
However, elements of both new devices regulations have applied directly in UK law since May 2017, meaning medical devices, including IVDs, can now be legally placed on the UK market if they are in conformity with the new regulations, invoking all relevant requirements.