Sep 23, 2019

The Medicines and Healthcare products Regulatory Agency (MHRA), Great Britain’s medical device market regulator, has published new details on the role and responsibilities of the UK Responsible Person if a no-deal Brexit withdrawal from the European Union comes to pass.

Updated guidance from MHRA released September 18, 2019 addresses many questions raised by Emergo by UL consultants regarding the regulator’s original draft issued earlier this year. The original guidance concerned a potential no-deal Brexit situation that was then foreseen for March 29th, 2019.

In that document rules were explained of how non-UK manufacturers could place their devices on the UK market. They would have to engage with a so-called “UK Responsible Person,” or UK REP. The role of the UK REP was described as quite similar to that of the Authorized Representative. However, draft legislation suggested a different setup of this role. Devices could only be placed on the market by a UK-based manufacturer or a UK REP, although “placing on the market” was explained as a role for the importer.

UK REP and Importer

The draft post-no-deal Brexit legislation and the MHRA guidance document have now been brought more in line.

  • It is only allowed for UK based manufacturers or UK-based UK REPs to place medical devices on the UK market, and they need to register themselves.
  • The manufacturer and UK REP will also be held liable for defective devices and they can be proceeded against under the Regulations or under the Consumer Protection Act 1987. Individuals may also be held liable.
  • Whereas in Europe the role of the Authorized Representative can be filled by an independent, experienced organization representing multiple companies, this will not be possible in the UK. It is likely companies will not feel capable or willing to take up this responsibility, so it may be difficult to find a UK based importer/UK REP.
  • The UK REP is also responsible for carrying out post-market surveillance activities.

MDR, Eudamed issues

It is also interesting to see that many of the requirements of the Medical Devices Regulation for the Authorized Representative have been copied here (see article 11 MDR). Missing are the requirements related to Eudamed, because in a no-deal situation Eudamed will not be available to the MHRA. Eudamed is a cornerstone of European supervision of medical devices, so it will be interesting to see how the UK will compensate for that.

Continuity of care in the UK

For registering as a UK REP and/or Importer, the following timelines apply, starting from Brexit day:

  • Within four months in case of Class III devices, Class llb implantable devices, active implantable devices and IVDs list A.
  • Within eight months for Class llb non-implantable devices, Class lla devices, IVDs list B and Self-tests.
  • Within a year for Class I medical devices, general IVDs and Class A IVDS (if complying with the IVDR).

Registration must be done by the UK-based manufacturer or the UK REP and the importer. These will typically be the same person. It is important to understand that while there may be “grace periods” for registration, there will not be such period for the requirement of having a UK REP and importer. As pointed out above, devices can only be placed on the UK market after Brexit if an importer/UK REP has been appointed.

It can be anticipated that with the guidance published on September 18th and Brexit possibly happening on October 31st, many EU manufacturers will not be ready to meet these new UK REP requirements. This would mean European manufacturers cannot place their devices on the UK market and it can be anticipated that this would result in a serious disruption of care in the UK. This disruption is caused by the way the UK crashes out of the EU, which is a the result of British political decisions. There is nothing the EU can do to prevent this.

Ronald Boumans is Senior Consultant, Regulatory Affairs at Emergo by UL.

Learn more about European and UK medical device regulations at Emergo by UL:

  • Brexit transition consulting and in-country representation support for medical device and IVD companies
  • EU MDR transition resource and support center
  • Webinar: Impact of a no-deal Brexit on the medical device sector