The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published in its website an overview of the post-Brexit regulations that will apply to medical devices in the event of a ‘no deal’ or ‘hard’ Brexit.
It confirms that the UK will leave the European Union (EU) on 31 December 2020, and so the new regulations will take effect from 1 January 2021, although there will be a transition period for certain aspects, such as continued recognition of the CE mark, that will end on 30 June 2023 for both general medical devices (MDs) and in vitro diagnostic devices (IVDs). Different regulations will apply in Northern Ireland from those that apply in Great Britain (GB, comprising England, Scotland and Wales), because Northern Ireland will effectively remain in the EU Customs Union.
The MHRA stresses that the proposals outlined in this overview will take effect through legislative changes that will be introduced later in 2020. They are still therefore subject to parliamentary approval, and at this point in time should be considered only as guidance.
Summary of key requirements for placing a device on the GB market:
From 1 January 2021, there will be a number of changes to how medical devices are placed on the market in GB. These are:
The role and responsibilities of the UKRP have not yet been clarified – the previous draft post-Brexit legislation essentially restricted anyone who was not the device importer form being the UKRP. The MHRA has indicated that the UKRP will basically have the same responsibilities and obligations as the Authorized Representative under the EU regulations (MDR and IVDR), but whether the roles and responsibilities of the UKRP and importer have been disentangled remains to be seen.
The UKCA (UK Conformity Assessed) mark is a new UK product marking that will be used for certain goods, including medical devices, being placed on the GB market after the transition period. The UKCA mark will not be recognized in the EU, EEA or Northern Ireland markets, and products currently requiring a CE marking will still need a CE mark for sale in these markets. Manufacturers will be able to use the UKCA mark from 1 January 2021, and from 1 July 2023, to place a device on the GB market, the requirements for placing a UKCA mark on a device must be met.
UK Conformity Assessment Bodies:
From 1 January 2021, the MHRA will be able to designate UK Conformity Assessment Bodies (CABs) to conduct assessments against UK requirements for the purpose of the UKCA mark.
UK Notified Bodies with designations under the MDD, IVDD or AIMDD will have their designations rolled over automatically, without having to undergo a new designation process. These Notified Bodies will be known as ‘Approved Bodies’ as of 1 January 2021.