Post-Brexit, from 1 January 2021, the United Kingdom (UK) will transition to a new medical device regulatory system, independent from the European Economic Area (EEA). Manufacturers located outside of the UK will need to follow UK laws, which are based on the previous Medical Device / In Vitro Device Directive-compliant regulations, but with many stricter requirements, based on the texts of the Medical Device / In Vitro Device Regulations (2017/745 and 2017/746).
One of the requirements that will apply immediately, from 1 January 2021, for all non-UK manufacturers, is that a UK-based UK Responsible Person (UKRP) must be designated. Donawa has opened a company based in the South of England to provide UKRP services to both its current European Authorized Representative clients, but also for those European device manufacturers who wish to continue marketing their devices in Great Britain. For clarification, Great Britain comprises England, Scotland and Wales. Northern Ireland is part of the UK, but will essentially remain within the EU Customs Union, so manufacturers there will still comply with European rules and affix the CE mark to compliant devices.
Medical device companies seeking UKRP services should designate only those companies that are qualified to offer such services and that can represent the company’s regulatory interests in an appropriate manner. The new Regulations stipulate that the UKRP is responsible for:
- Ensuring that the device 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.
- In response to a request from the MHRA, providing the MHRA with all the information and documentation necessary to demonstrate the conformity of a device.
- Providing samples of a device to the MHRA or allowing the MHRA access to the device where the UKRP has samples or access or, where they do not have access or samples, forwarding to the manufacturer any request from the MHRA for samples or access.
- Cooperating with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate 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 the applicable Regulations and informing the MHRA and, if applicable, the relevant Approved Body of that termination.
Donawa’s experience in meeting AR requirements over the last 20 years provides us with the expertise to meet these new requirements, via our British sister company, Donawa Lifescience Ltd., and is also able to provide expert regulatory advice to its UKRP clients on an as-needed basis.