Dear Madam, dear Sir,
The whole EU, including UK is relieved about the postponement of the Brexit until the end of October, but a no deal scenario is still possible and the uncertainty remains. What we know for sure is that a no deal scenario will have an impact on the CE marking of products coming from Great Britain. This will affect, for example, electrical equipment, medical devices and machinery. This letter sets out how medical devices will be regulated in the UK in a no deal scenario. Currently the European regulatory network for medical devices are responsible for handling the CE marking all over Europe.
With the UK’s withdrawal from the EU the Medicines and Healthcare products Regulatory Agency (MHRA) would take over and continue to perform market surveillance of medical devices on the UK market as well as take a decision over the market access to the UK. Manufacturers wishing to place a product on the UK market should register with MHRA as soon as possible. Devices that are CE marked under and fully comply with the current EU legislation for medical devices and later with the EU MDR and EU IVDR will be allowed to be placed on the UK market.
In terms of regulations, the UK MDR 2002 will ensure that the EU AIMDD, EU MDD and EU IVDD will continue to apply to the UK and the new amendment to the UK MDR 20002, the UK MDR 2019 will be brought into force in line with the transitional timetable of the EU MDR and EU IVDR. Currently the plan is to have a similar regulatory foundation in both legislations. The UK MDR 2002 and the UK MDR 2019 set out the requirements that a manufacturer must meet to continue operating in the UK.
Manufacturer and supplier of medical devices must be prepared that the UK-based Authorized Representatives are no longer be recognized in the EU. On the UK side, a new role, known as UK Responsible Person will be created for manufacturers based outside of the UK. It is also very important to note that there must be someone physically located within the UK. Further information about manufacturers’ obligations and the UK Responsible Person can be found in the amended MDR 2002, specifically in the regulation 77 and regulation 146 for medical devices and IVDs respectively.
In case of a no deal Brexit importers and distributers of medical devices to the UK are obliged to additional requirements laid down in the regulation 78 for medical devices and the regulation 147 for importers and regulation 79 and 148 for distributers of the amended UK MDR 2002.
The status of UK Notified Bodies remains unclear, but it is to be expected that the EU will no longer recognize these Bodies and neither their certificates. These would mean that the lack of CE marking would prevent market access for these devices in the EU. Placing a device on the UK market that needs the involvement of a Notified Body will thus allow the interested party to choose a Body recognized either in the UK or in the EU, whereas placing a device in the EU will always need a body recognized in the EU. If you need further assistance do not hesitate to contact us - updated information can also be found on the corresponding gov.uk website.