Searching for a UK Responsible Person?
We would like to tell you more about the Qserve UK Rep, UK RP services.
More information
What is the main impact for manufacturers after Brexit
1. A new regulation in the UK (UKCA) will become mandatory by July 2025. Until that date, there is a grace period, and the EU CE mark will be accepted.
2. Devices/IVDs that will be placed on the UK market will need to be registered with the MHRA. Manufacturers need to appoint a UK RP to perform the registration.
3. The manufacturers need to appoint the legal UK-based entity as UK Rep as soon as possible.
4. Registration deadlines depend on the classification of the devices/IVDs:
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Class IIIs and Class IIb implantables, all active implantable medical devices; Annex II List A IVDs
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Class IIb non-implantable, all Class IIa devices; IVD List B, and Self-test IVDs
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Class I devices and General IVDs.
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5. Until the new UK regulation (UKCA) becomes mandatory, devices/IVDs that are in compliance with the following directives/regulations can be placed on the UK market: MDD, MDR, IVD and IVDR.
6. The UK Responsible Person name and address, 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.
7. 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.
For more information about the UK Medical device regulation from January 2021, click here.
Responsibilities of the UK Responsible Person
- Check the CE certificate (if applicable), the Declaration of Conformity (DoC), and technical documentation.
- Register the medical devices / IVD in the MHRA database.
As your UK Rep (UK RP), Qserve will act on behalf of your company and provide support with:
a) Communicate and respond to requests from the MHRA
b) Provide the MHRA with information and documentation necessary to demonstrate the conformity of a device.
c) Forward MHRA requests for samples or access to a device, and ensure that the MHRA receives the samples or has been given access to the device.
d) Cooperate with the MHRA on any actions taken to eliminate or, if not possible, mitigate the risks posed by devices.
e) Support your company with vigilance communication - complaints and reports received from healthcare professionals, patients and users about suspected incidents related to the registered devices/IVDs.
f) Keep available copies of the technical documentation, declaration of conformity, and, if applicable, the relevant certificate, including any amendments and supplements for inspection by the MHRA.