The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published on its website full details of how the device registration system for the UK will operate post-Brexit, from 1 January 2021.
As already known, only UK entities will be allowed to make the device registrations, these being either UK device manufacturers, UK Responsible Persons (UKRPs) for non-UK manufacturers, and Northern Ireland (NI) Authorised Representatives for non-European manufacturers.
The MHRA webpage includes a link to a spreadsheet which indicates the fields for which each registration must be completed. Unfortunately, this shows that the Agency has move from it’s historic regulatory ‘light touch’ position to one where the amount of data now required for registration far exceeds what has generally been required in those European countries that mandated local registration.
Registrations will need to be made using the existing MHRA DORS account, and must be made within timescales set by MHRA, depending on risk categorisation, up to 31 December 2021.
Different requirements apply in NI because, post-Brexit, NI will effectively remain within the European Customs Union, and will this be subject to EU regulations, including CE marking.
Non-UK manufacturers are reminded of the need to designate a UKRP as soon as possible, because the requirement takes effect from 1 January 2021.