The UK has updated its guidance on the UK Responsible Person. The document is applicable should the UK leave the EU without a deal and includes important details about the role and obligations with the corresponding details.
Background details on the UK Responsible Person
We have reported earlier this year that – if the UK should leave the EU without a deal – manufacturers who are not based in the UK, but aiming to place their devices on the UK market, will need a “UK Responsible Person”. Against this background, the role of the EU Authorized Representative won’t be applicable anymore in the UK. Vice versa, this also means that UK based EU Authorized Representatives won’t be recognized in the remaining EU countries.
The British MHRA has now updated its guidance on the role and responsibilities of the UK Responsible Person. Basically, these are in line with the obligations of an EU Authorized Representative under the Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR).
What timelines are involved and what are the crucial points?
Please find below a summary of the deadlines manufacturers must keep for the appointment of a UK Responsible Person and the appointment of a UK Responsible Person:
|4 Month||8 Month||12 Month|
|Class III||Class IIb non-implantable||Class I|
|Class IIb implantable||Class IIa medical devices||General IVDs|
|Active Implantables||IVD List B||Class A IVDs|
|IVD List A||Self-test IVDs|
In terms, of obligations the MHRA states as follows:
- ensure 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
- keep 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, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device
- forward to the manufacturer any request by the MHRA for samples, or access to a device, and ensure that the MHRA receives the samples or has been given access to the device
- cooperate 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 inform 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
- terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the MHRA and, if applicable, the relevant notified body of that termination
Furthermore, and that is also in line with the MDR and IVDR, the UK Responsible Person can be held liable against potential claims.
For further details, please read the full post under https://www.gov.uk/guidance/regulating-medical-devices-in-the-event-of-a-no-deal-scenario.
As always, please be assured that we will keep you updated with any developments in this regard.