MHRA Guidance on a No-Deal Brexit
Regulatory Updates |
EMERGO BY UL SUMMARY OF KEY POINTS:
- MHRA will take on responsibility for the UK market;
- The CE Mark remains valid in the UK and no label changes are foreseen for now;
- MDR and IVDR will be implemented in the UK in parallel with the EU
- Non-UK manufacturers placing devices on the UK market need to appoint a UK Responsible Person, a role similar to that of the European Authorized Representative
- The UK-based manufacturer or the UK Responsible Person must register the device in the UK.
On January 3rd, 2019, the MHRA published guidelines for the situation of a no-deal Brexit. If no agreement is reached, the UK may decide to leave the EU without any deal. Then the UK will become, from the perspective of the EU, a “third country.” Imports from third countries are captured in EU rules, but for goods moving from the EU to the UK these rules currently do not exist. The same goes for rules for non-EU manufacturers that want to place devices on the UK market. Therefore these MHRA guidelines are well appreciated, although the time for preparations is short.
This document contains an explanation of the legal situation, but is not itself legally binding. Therefore care should be taken in implementing its consequences. If something is not clear, one should ask MHRA about this. Such questions may trigger publication of additional guidelines.
Placing devices on the UK market
In order to allow medical devices onto the UK market, MHRA will take on responsibilities for device oversight in Britain. Devices being placed on the market would still require CE Marking, and the MDR and IVDR will be implemented in the UK just as in the EU. Market surveillance activities will be carried out by MRHA, but they will no longer be part of the EU market surveillance system, nor will they automatically follow decisions of the Court of Justice of the EU. Therefore we may see some divergence between the UK and the EU markets.
Another difference has to do with UK-based Notified Bodies (NBs). From Brexit day forward, these NBs will no longer be recognized in the EU27 and therefore their certificates will become void. However, MHRA will recognize these certificates for the time being. Manufacturers that switch from a UK-based NB to one that is based in the EU27 can also keep placing their devices on the UK market as their CE Mark remains valid in the EU.
MHRA registration timelines
Manufacturers based outside the UK, whether EU-based or non-EU-based, must appoint a UK Responsible Person (UK REP) that must be based in the UK. The role and tasks of the UK REP are similar to those of the European Authorized Representative, the EU REP. It is for now not required to indicate a UK REP on a device label. UK-based manufacturers, or their UK REPs, must register their devices with MHRA. There are timelines for this registration:
- Within four months after Brexit for Class III devices, Class llb implantable devices, active implantable devices and IVD List A devices;
- Within eight months after Brexit for Class llb non-implantable devices, Class lla devices, IVD List B devices and Self-test IVDs;
- Within 12 months after Brexit for all other devices (Class I and self-certified IVDs).
Registration can initially be done at the level of Global Medical Device Nomenclature (GMDN) code, allowing groups of products to be registered in one record (Class III devices excepted). At the moment MDR and IVDR apply, MHRA will mirror Eudamed and will require manufacturers to register in this database as well. It is not clear if this will be fully synchronized with the implementation of Eudamed.
Although it is not certain the UK will leave the EU without a deal, the likelihood of this event is increasing. All involved should prepare for this scenario and make sure the continuity of care will not be disrupted. Emergo by UL will follow developments closely and inform medical device industry stakeholders.
Learn more about European and UK medical device regulatory requirements:
- European CE Mark strategy and consulting for medical devices
- Brexit transition consulting and in-country representation
- European Authorized Representative in-country representation
- European MDR 2017/745 gap assessment and transition strategy for medical device companies