The latest guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) regarding the new regulations that have been put in place for a post Brexit market in the United Kingdom (UK), Northern Ireland (NI) and the European Union (EU), has been released. These new regulations will be in effect from 1st January 2021.
In addition to all updated regulations, a new role, UK Responsible Person, was created under MDR 2002 (as amended by the UK MDR 2019). As of 1st January 2021, all medical devices manufactured outside of the UK will require a UK Responsible Person to represent and register their product for sale in the UK market. The UK Responsible Person is defined 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.”
The UK Responsible Person will support many different regulations of the products they are representing. We have highlighted some of their duties which are listed on the gov.uk website. These include;
- Ensuring the declaration of conformity and technical documentation have been drawn up and, where applicable, that the manufacturer has carried out an appropriate conformity assessment procedure
- Having an available copy of technical documentation, declaration of conformity, and, if applicable, relevant certificates, 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
- Forwarding requests made by the MHRA for samples to the manufacturer to ensure that the MHRA has samples or has been given access to the device
- Cooperating with the MHRA on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices
- Informing the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents relating to a device for which they have been designated
- Terminating legal relationship with the manufacturer if they act contrary to its obligations under these Regulations and inform the MHRA and the relevant notified body of that termination
These responsibilities may differ between each manufacturer and UK Responsible Person and need to be documented on the mandate drawn up between the two entities. Regardless of the UK Responsible Person responsibilities, all regulatory obligations for the product still need to be fulfilled by the manufacture.
At Ortho Consulting Group (OCG), we have registered to become a UK Responsible Person to provide this capability to orthopaedic and spine companies who want to sell or keep selling their devices within the UK markets.
If you are interested in finding out more about this service, please contact us today via:
Tel: (+44) 203 011 5574
Source: gov.uk, 12th November 2020