Do you want to market your medical devices in the united kingdom?

Following Brexit, the United Kingdom has started to introduce new rules for the marketing of medical devices (MDs) and in vitro diagnostics (IVDs) on its territory.

The regulation is evolving and the British Government, together with the Medicines and Healthcare products Regulatory Agency (MHRA), the national competent authority for medicinal products and medical devices, is preparing a national regulation that is going to replace the regulations currently in force, namely Medical Device Regulations 2002, no 618 (MDR 2002), the British implementation of the “old” European Directives 90/385/EEC, 93/42/EEC and 98/79/EC.

Following the Brexit date of application, some novelties have already been introduced in the current regulation text. Among these, one of the most important as well as the most impactful (so far), for all companies interested in the UK market is the introduction of the United Kingdom Responsible Person (UKRP).

United Kingdom Responsible Person

As of 1^st January 2021, non-British companies wishing to sell their medical devices and/or in-vitro diagnostics in Great Britain shall appoint a “United Kingdom Responsible Person” (UKRP), i.e. a person or an entity acting as intermediary between the manufacturer and the British regulatory authorities.

The “UK Responsible Person” is a subject located in the United Kingdom representing the manufacturer. Such role was introduced in UK following the post-Brexit regulatory adjustments, in particular through the S.I. 2019/791 amending the MDR 2002.

The information regarding the UK Responsible Person shall be stated in the label of all MDs and IVDs declaring their conformity with the British regulations.

The inclusion of such information in the label is not mandatory for MDs and IVDs entering the British market based on a EU MDR conformity, i.e. with the sole CE marking, however the UKRP should be appointed, and even more importantly, MHRA has to be informed about such appointment.

What are the obligations of the united kingdom responsible person?

The obligations of the UK Responsible Person for Medical Devices are established in the UK Regulation MDR 2002.

In particular, the UK Responsible Person shall:

• Register medical devices in the database instated by the British Competent Authority (MHRA);
• Keep available copy of the technical documentation and copy of the declaration of conformity;
• Keep available copy of the relevant certificate, including any change and addition for inspection by the MHRA (if applicable);
• Ensure that the declaration of conformity and the technical documentation have been drafted;
• Ensure that an appropriate conformity assessment procedure has been carried out by the manufacturer (if applicable);
• Provide all information and documentation required to demonstrate the conformity of a device on request of the MHRA;
• If they have samples or access to the devices, comply with any request of supply or access to samples and devices by the MHRA; in case of no samples or access to devices, inform the manufacturer of the body’s requests and reply to MHRA if the manufacturer intends to meet such request;
• Cooperate with MHRA on any preventive or corrective action taken to remove or, if this is not possible, to mitigate the risks posed by devices;
• Informa the manufacturer of any decision taken by MHRA regarding any possible restrictions or withdrawal from the market;
• Cooperate with the manufacturer in case of complaints or reports;
• Inform immediately the manufacturer regarding reports from health professionals, patients and users on suspected incidents regarding a device for which they have been designated.

Finally, it is a right/obligation of the UK Responsible Person to terminate a legal relation with the manufacturer and inform MHRA and, if applicable, also the notified body about such termination in case the manufacturer acts against their obligation according to the regulation in force.

What can di renzo regulatory affairs do for you?

Di Renzo Regulatory Affairs is a company specialised in advice and support to enterprises operating in the sector of medical devices and in vitro diagnostics.

Our mission is to help our clients to obtain all authorisations required to market their products in the different markets, ensuring the compliance with the regulations in force as well as the safety of patients.

In order to offer a complete and qualified service to our clients, Di Renzo Regulatory Affairs has opened an office in Great Britain, located in London, taking on the role of UKRP.

In this way, we are able to provide non-British companies with the support needed to adjust to the new legal provisions and continue the marketing of their medical devices in Great Britain.

To learn more on our UKRO service you can visit our website or, if you need assistance for the registration of your devices in Great Britain do not hesitate to contact us. We will be glad to answ