UK Responsible Person for Medical Devices - Background
When the United Kingdom (UK) left the European Union (EU) it became what is known as a 3rd country. This meant that the UK would no longer follow new EU legislation.
The EU repealed the Medical Device Directives in 2017 and brought in new Medical Device Regulations (The Medical Device Regulations (MDR) EU 2017/745 and the In Vitro Diagnostic Regulations (IVDR) EU 2017/746). However, due to the UK leaving the EU in 2016 the UK did not adopt the EU MDR and IVDR.
The UK follows the UK Medical Device Regulations 2002 (as amended), these regulations are based on the old EU Medical Device Directives. The UK Medical Device Regulations 2002 were updated post Brexit to make previsions for the aspects of the EU law that would not be applicable to the UK anymore. One of these requirements was the need to have a UK equivalent of the EU Authorised Representative. The UK Regulations introduced the term and requirement for a UK Responsible Person.
What is a UK Responsible Person?
Manufacturers who are not registered businesses in the UK but wish to place medical devices or In Vitro Diagnostics (IVDs) on the UK market, are not allowed to do so without having in place an agreement with a UK registered organisation. This organisation is the UK Responsible Person, and represents and registers the manufacturers medical devices and IVDs with the Medicines & Healthcare products Regulatory Agency (MHRA).
All Medical Device and IVD manufacturers who place Medical Devices or IVDs on the UK market are required to register as a manufacturer with the MHRA, including class I medical device manufactures who self certify, and self certified IVDs.
What does the UK Responsible Person do?
The UK Responsible Person must provide written evidence that they have the manufacturer’s authority to act as their UK Responsible Person. Importers and distributors are not required to appoint a UK Responsible Person.
The UK Responsible Person acts on behalf of the non-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. As noted above, this includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the UK market.
The responsibilities of the UK Responsible Person are set out in the UK MDR 2002. Here are some of the activities carried out by the UK Responsible Person:
- 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.
- Where they have samples of the devices or access to the device, comply with any request from the MHRA to provide such samples or access to the device.
- Where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the MHRA to provide such samples or access, and communicate to the MHRA whether the manufacturer intends to comply with that request.
- 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 appointed.
- If the manufacturer acts contrary to its obligations under these Regulations:
- terminate the legal relationship with the manufacturer; and
- inform the MHRA and, if applicable, the relevant Approved Body of that termination.
Do you need a UK Responsible Person?
If you are a Medical Device and/or IVD Manufacturer without a registered business in the UK, then you do need to have a UK Responsible Person. This includes businesses based inside the EU. After the UK left the EU, all EU based Medical Device and IVD manufacturers who sell into the UK are required to have a UK Responsible Person.
If you have identified that you need a UK Responsible Person. Then Patient Guard can represent you as your UK Responsible Person. We have helped many Medical Device and IVD Manufacturers with their UK compliance needs.