AUTHORISED REPRESENTATIVE (UK RESPONSIBLE PERSON)

If you are a manufacturer of a Medical devise outside the UK you are required under the directives to appoint an Authorised Representative. POISE Medical RA Ltd is able to act as your Authorised Representative in both Europe and also within the UK should there be a no deal Brexit or if the deal doesn’t include some form of mutual recognition between the EU and the UK.

POISE Medical RA Ltd is able to offer the service of operating as your Representative in the UK covering any scenario relating to Brexit.

UK AUTHORISED REPRESENTATIVES

For medical devices and in vitro diagnostic medical devices (IVDs), any UK-based Authorised Representative will no longer be recognised under EU law. This means they will not be recognised as able to carry out tasks on the manufacturer’s behalf for the purposes of placing products on the UK market. In order to place devices on the UK market, manufacturers with an Authorised Representative based in the EU will need to establish a new Authorised Representative in the UK. 

A new role – the UK Responsible Person – has been created under the UK MDR 2002 (as amended by the UK MDR 2019), which applies from the day the UK leaves the EU. The UK Responsible Person, who must be established in the UK, acts on behalf of a manufacturer established outside the UK to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering with the MHRA before the device is placed on the UK market.

You can read more about the UK Responsible Person’s obligations in regulation 77 (for medical devices) and regulation 146 (for IVDs) of the UK MDR 2002 (as amended by the UK MDR 2019).

Extract of the UK MDR 2019 regulation 77 is as follows: - 

A person regarded as the UK responsible person must— 

 (a) 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. 

 (b) keep available for inspection by the Secretary of State 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. 

 (c) in response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device; 

 (d) forward to the manufacturer any request by the Secretary of State for samples, or access to a device and ensure that the Secretary of State receives the samples or has been given access to the device;

 (e) cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices; 

 (f) 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; (a) 2018 c. 12. 40 

 (g) terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the Secretary of State and, if applicable, the relevant notified body of that termination.

 POISE Medical RA Ltd is able to offer the service of operating as your Representative in the UK covering any scenario relating to Brexit.