As a part of the Brexit, UK left the European Union on January 31, 2020, with a trade deal that requires non-UK manufacturers to appoint a UK Responsible Person for registering their medical devices, with the MHRA.
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. The MHRA performs market surveillance of medical devices on the UK market and is able to take decisions over the marketing and supply of devices in the UK. The MHRA is responsible for the designation and monitoring of UK conformity assessment bodies. The MHRA requires its own version of a “UK Authorised Representative”, called a UK Responsible Person (UKRP).
As noted above, to place a device on the Great Britain market (England, Wales and Scotland), manufacturers based outside the UK are 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. This includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the Great Britain market.
The name and address of the UK Responsible Person, where applicable, 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. UK Responsible Person details do not need to be included on labelling for CE marked devices, unless the device bears both the CE and UKCA markings.
The responsibilities of the UK Responsible Person are set out in the UK MDR 2002 as under.
As of 1 January 2022 (“Brexit”), appointment of a UK Responsible Person is mandatory before a medical device or IVD can be placed onto the Great Britain market. The UKRP is also responsible for registering the manufacturer’s products with the MHRA. If a manufacturer places devices onto the Great Britain market without completing these steps, the manufacturer is out of compliance.
The MHRA has not yet released a UKRP symbol for UK representatives. Since there is only one national language in the UK, it is possible the MHRA will not release a UKRP symbol and instead will require the text ‘UK Responsible Person’ or ‘UKRP’ be written in English.
NOTE: Northern Ireland, the fourth UK country, still requires anEU Authorised Representative.
The registration is more of a notification process. The registration is not intended to validate the medical device’s safety or efficacy. In fact, the MHRA’s registration confirmation letter and registration guidance both explicitly state that the registration does not constitute an approval or certification of the device. Therefore, devices must be CE Marked or UKCA Marked before they can be registered. Proof of CE or UKCA Marking must be provided in the MHRA registration application.
Once the registration has been granted, the manufacturer and the medical device(s) will be listed on the MHRA’s public registration database. The registration must be renewed one year after being granted. Thereafter, renewals are required every two years. The MHRA currently does not charge a renewal fee.
Further, if there are any changes to the information originally supplied in the registration (e.g., device characteristics, manufacturer address, etc.), this must be updated in the registration. Fees may apply, depending on the type of change.
We make the journey of MHRA registration smooth and simpler with our first virtual call which if free
We compile the documents as per the MHRA requirements on your behalf.
We will act as Your Responsible Person.
We will act as Your Responsible Person.
We also offer the additional service to our clients who wish to explore and enter into the UK public sector market through our dedicated team.
Thank you for visiting our website, and please feel free to get in touch with us at info@headingtonmedical.co.uk to learn more about how we can collaborate and make a positive impact on the healthcare industry together.