When the UK leaves the European Union, a new role created under the UK MDR 2002 (as amended by the UK MDR 2019) becomes mandatory for manufacturers of medical devices. Those manufacturers NOT established in the UK need to designate a ‘UK Responsible Person’ to act on their behalf and to legally place medical devices on the British market after Brexit.

Definition

According to the UK MDR 2019 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.

Requirements

First of all, the term “person” means either an individual or a legal person (i.e. a company). When a company provides the service of “UK Responsible Person” the responsibilities fall to the whole company. The qualifications or the knowledge of the UK Responsible Person are various, the most important requirement is that the UK Responsible Person must be established and physically located in the UK. The registered business address will be used for official communications and you must be contactable at this address.

Responsibilities

The requirements of the UK Responsible Person are the same as for a European Authorised Representative. The UK Responsible Person must:

• 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, the UK Responsible Person needs to register medical devices of overseas manufacturers with the MHRA before placing them on the UK market. If set out in the contract the UK Responsible Person can also be responsible for defined post-market surveillance tasks.

For further information relating to the requirements and responsibilities of the UK Responsible Person please follow this link:https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#responsible