Have you appointed the right UKRP? – Part 1
If you are currently providing a UKRP service or if you are an Ex-UK Medical Device or IVD manufacturer who requires the services of a UKRP, you should consider the following information very carefully.
This is the 1st article in a 3-day, 3-part series which considers some of the upcoming changes to the UK devices regulations and the implications on the UKRP legal service. These articles are intended to support your risk management process and strategic planning.
Between September and November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) consulted on proposed changes to the regulatory framework for medical devices in the United Kingdom (UK). The government response was provided to industry on 26th June 2022.
Within this response, the UK government has clarified that it intends to extend the UK Regulations to better align with international best practices. On the whole, the upcoming changes will bring the UK regime into line with the requirements in the EU MDR and refer to international definitions and guidance, such as from the International Medical Device Regulators Forum (IMDRF).
**Caveat** The Government has indicated that they will provide further clarity in guidance how some of the requirements described in the following 3 articles should be met in practice.
Although the future UK Medical Device Regulations have yet to be published and the UK Government has recently indicated a 12-month extension to the standstill period of implementation (not yet binding in law), the Government’s intentions are clear and the clock is ticking. Please also note that the new UK MDR post-market requirements are intended to be fully applicable prior to the new standstill deadline.
1. Physical location
Response to Consultation, 12.2
It is the intention of the UK Government to ensure that the UK Responsible Person (UKRP) shall have an address in the UK at which they are physically located. UKRPs who operate by uploading a “forwarding address” to the MHRA registration system will no longer be permitted to legally operate on this basis.
Action – Make sure that you have appointed a UKRP who has a person(s) physically located within the UK. This will ensure that the MHRA has a UK-based point of contact for your medical device(s) being placed on the market.
Authors notes: If your UKRP currently operates on the basis of a UK-forwarding address, you should immediately seek confirmation that they will change this business model. You may need to consider an alternative UKRP to ensure that your devices are not orphaned. Be in control of your agenda and business planning.
In part 2 (Wednesday), we will take a quick look at the new requirements for the UKRP to have available a Qualified Person, new obligations. We will also take a look at new liabilities
Strategic Development Director