As of 1st January 2021, non-UK based manufacturers are legally required to appoint a UK Responsible Person (UKRP) to act on their behalf with UK Regulators in order to place their devices on the market here in the UK.
What is a UKRP?
A UKRP is a UK Responsible Person that acts on behalf of businesses based outside the UK to carry out all tasks needed to successfully place their device on the UK market and liaise with entities such as the MHRA.
MHRA stands for Medicines and Healthcare products Regulatory Agency and is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
What are the requirements for placing a device on the UK market?
First of all, an important distinction needs to be made between the requirements of the United Kingdom and Great Britain (England, Scotland and Wales), because different rules apply in Northern Ireland and in Great Britain[1] under the Northern Ireland Protocol.
The requirements for businesses wanting to enter the market in Great Britain are as follows as of January 2021:
- Registering with the MHRA
- Appointing a single UK Responsible Person (UKRP) for all of their devices. This person will act on their behalf to carry out specified tasks, such as registration
- Compliance with relevant product marking and conformity assessment requirements for medical devices
For businesses placing devices on the Northern Ireland market, where the EU MDR and EU IVDR have applied in Northern Ireland respectively since May 2021 and May 2022, the requirements are instead CE marking and the UKNI indication if a UK Notified Body undertakes mandatory third-party conformity assessment plus registration with the UK MHRA for certain products, including in vitro diagnostic medical devices (IVDs).
How do I select a UKRP?
It is critical that UKRPs are physically located in the UK. Their name and address must be included on the product labelling or the outer packaging, or the instructions for use in cases where the UKCA marking has been affixed[2]. They are also legally responsible on a par with manufacturers. Their responsibilities are detailed in the UK MDR 2022[3], but can be summarized as follow:
- Registering Ex-UK manufacturers and their products with MHRA and then maintaining those registration.
- Liaising and collaborating with the MHRA on matters such as PMS, CAPA and sample requests
- Ensuring the declaration on conformity and all technical documentation have been drawn up
- Keep available a copy of all relevant documentation, including a copy of the declaration of conformity and relevant certificates and making it readily accessible
- Immediately informing the manufacturer about complaints and reports from healthcare
- Be physically located in the UK
- Register medical device importers with MHRA
Appointing a single UK Responsible Person (UKRP) to act on their behalf is the first, most important thing businesses based outside the UK need to do to place a device on the Great Britain market as they will be their key go-between with the MHRA. This means that choosing the right partner plays a key role in determining the future success of a device in entering the market.
While previously it was more common for an importer or distributor to also act as a UKRP, the newly defined responsibilities of the UKRP will very soon require a much deeper understanding of the regulatory landscape for medical devices and a greater responsibility will be placed upon your designated UKRP, making it critical to entrust this role to specialists in regulations. Manufacturers should consider UKRP providers that offer experience in dealing with institutions and changing regulatory environments that can support them with exiting but also future regulatory requirements.
Visit our UKRP website to discover how IMED Consultancy’s proven international medical regulatory experience can help you stay ahead of new regulations and UKRP requirements!
[1] Gov.uk, Regulating Medical Devices in the UK
[2] Gov.uk, Regulating Medical Devices in the UK
[3] Legislation.gov.uk, The Medical Devices Regulations 2022
