On October 17, 2019, the EU and UK announced that a Brexit deal has been agreed upon, but needs to be ratified. The outcome is still uncertain as the British parliament is in gridlock. The UK could still leave the EU with no deal on 31 October 2019 if the parties involved do not approve and sign the withdrawal agreement until such date.
In case of “no-deal” Brexit, all Medical Devices placed on the UK market will have to be registered with MHRA, the competent Regulatory Authority. Only a UK-based manufacturer or a UK Responsible Person (UK RP), meaning an entity with a registered place of business in the UK, can do this. Therefore, starting November 1st, 2019, foreign manufacturers must designate a UK RP to act on their behalf.
The requirement to appoint a UK RP is in line with the grace period for registering the Medical Devices with MHRA, as follows:
- 4 months (by the end of February 2020) for class III Medical Devices, class IIb implantable Medical Devices, active implantable Medical Devices and IVD List A;
- 8 months (by the end of June 2020) for class IIb non-implantable Medical Devices, class IIa Medical Devices, IVD List B and Self-test IVDs;
- 12 months (by the end of October 2020) for class I Medical Devices, general IVDs and class A IVDs (if complying with the EU IVDR 2017/746).
Foreign Manufacturers are urged to appoint a UK RP before the end of the grace period for post-market surveillance purposes. A manufacturer may sell directly to the end user in the UK provided that they have appointed a UK RP to register them with MHRA before they can be placed on the UK market. Furthermore, a single manufacturer may have several designated UK RPs.
No immediate labelling changes will be required to reflect the role of the ‘UK RP’. However, changes to the labelling requirements for Medical Devices will come into force in May 2020. The UK MDR will mirror the (UE) 2017/745. As such, the name and address of the UK RP will be required to appear on the label, similar to what is expected for the EU REP, in compliance with Schedule 3 (Part 3) of the UK MDR 2002 (as amended by the UK MDR 2019).
Please bear in mind that, considering the degree of uncertainty associated with Brexit, any views provided on the interpretation of the legislation represent our best judgement at the time, based on the available information.