As the Brexit deadline is fast approaching, the occurrence of a no-deal Brexit is likely. In this context, the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK has updated its no-deal Brexit guidance on the regulation of medicines, medical devices, and respective clinical trials. According to the update, medical device manufacturers wishing to place a device in the UK market must have a ‘UK Responsible Person’ to register their devices with the MHRA, as similar to the European Union (EU) authorized representative.
To put it simply, for manufacturers outside the UK, only a designated UK Responsible Person can legally place a device in the UK market. The ‘UK Responsible Person’ can be either an individual or a company and should be physically located in the UK. However, the UK Responsible Person of a non-UK manufacturer requires documentary evidence supporting his position. The documentary evidence should be in the form of a headed letter or a signed contract and state that the UK Responsible Person adheres to the legislation that applies to the devices placed in the UK market.
The Role of A UK Responsible Person
While regulating medical devices in the event of a ‘no-deal Brexit’, from registration of devices to their post-market surveillance, the responsibilities of the UK Responsible Person are to:
- Ensure that the declaration of conformity and technical documentation is drawn up and, where applicable, an appropriate conformity assessment procedure is carried out by the manufacturer
- Keep available a copy of the technical documentation for inspection by the MHRA, a copy of the declaration of conformity, and if applicable, a copy of the relevant certificate, including any amendments and supplements
- Provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device in response to a request from the MHRA
- Forward the MHRA’s requests for samples or access to a device to the manufacturer and ensure that the MHRA receives them
- Cooperate with the MHRA on any preventive or corrective action taken to eliminate or mitigate the risks associated with the devices
- Inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to the device for which they are designated
- Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to the obligations under these regulations and inform the MHRA and, if applicable, the relevant notified body of that termination
The requirement for a manufacturer to have a UK Responsible Person in place will be in line with the grace period, which ranges between four and twelve months, to ensure the smooth registration of medical devices with the MHRA.
As the Brexit is still under the carpet of uncertainty, there is more scope for multiple Regulatory changes. Hence, to align with the changing regulations and to have compliant access to the UK market, organizations must keep track of MHRA’s guidelines and Regulatory updates and be able to interpret and implement them.