On 18 September 2019, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance regarding the role and responsibilities of the “UK Responsible Person”. This is part of MHRA’s continued effort to regulate medical devices in the event of a no-deal Brexit. With the possible withdrawal of the UK from the European Union at the end of October 2019, the UK Responsible Person would be the UK equivalent of the EU Authorised Representative the role of which will then disappear as regards the UK.
The Medical Devices Regulations 2019 (UK MDR 2019) amended the existing Medical Devices Regulations 2002 (UK MDR 2002) to create this new role. The UK MDR 2019 defines the “UK Responsible Person” as “a person established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer’s obligations under these regulations“. This includes registering with the MHRA before a medical device is placed on the UK market.
The key responsibilities of the UK Responsible Person are set out in each new registration requirement of the UK MDR 2002, as amended by the UK MDR 2019. These include:
- ensuring that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
- keeping available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA;
- providing the MHRA with all the information and documentation necessary to demonstrate the conformity of a device in response to a request from the MHRA ;
- forwarding to the manufacturer any request by the MHRA for samples, or access to a device, and ensuring that the MHRA receives the samples or has been given access to the device;
- cooperating with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigating the risks posed by devices;
- immediately informing the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;
- terminating the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and informing the MHRA and, if applicable, the relevant notified body of that termination;
- opening a single registration account on behalf of the manufacturers that it represents;
- where applicable, ensuring that the Post-market surveillance responsibilities set out in the mandate drawn up between the manufacturer and the UK Responsible Person are complied with.
Although the Guidance uses the term “person”, both an individual (i.e. a sole trader) or a legal person (i.e. a company) may be designated as a responsible person in the UK. UK-based importers who have been granted the necessary prior authority by the medical device manufacturer may become UK Responsible Persons.
Dependent on the risk category of the medical device, manufacturers from outside the UK will be granted between four and 12 months after a no-deal Brexit to appoint a UK responsible person. As after exit day, all medical devices will need to be registered with the MHRA prior to being placed on the UK market, manufacturers will benefit from this grace period. These extensions are provided in the guidance on registrations to allow time for compliance with the new registration process.