After December 31, 2020, after the United Kingdom left the European Union, the United Kingdom faced a new regulatory situation. It has had to define a new legal framework, and in turn, separate for Great Britain and Northern Ireland.
UKRP stands for UK Responsible Person. Each medical device manufacturer located outside the United Kingdom (UK) is required to appoint a UK Responsible Person (UKRP), on their behalf, as a prerequisite for device registration and launch in the UK. This person will be responsible for registration at MHRA, or to the competent authority.
Summary:
Non-UK manufacturers shall have a UK Responsible Person based in the UK.
All devices placed in the UK need to be registered with the MHRA. For non-UK manufacturers, this registration is to be performed by the UKRP.
Is there any Legal Basis for a UKRP?
It is a pre-requisites to appoint a UKRP, responsibilities of a UKRP and other related information is defined in the UK MDR 2002, for Medical Devices, Machinery, Cosmetics and others.
When should a Medical Device Manufacturer Appoint a UKRP?
Manufacturers of medical devices, machinery and other products with products already marketed in the UK must appoint a responsible person in the UK by 1 January 2021. New device manufacturers intending to place their device on the UK market must designate a UKRP prior to device registration. The UK Responsible Person will need to register the devices with the MHRA or appropriate identity and issue the relevant Declarations of Conformity.
What are the Responsibilities of a UKRP?
The UK Responsible Person (UKRP) is responsible for:
Act on behalf of the foreign manufacturer and register the devices with the MHRA before placing them on the UK market.
Ensure that all applicable device technical documentation and declaration of conformity documents are available for the device in scope and that the device manufacturer has completed the conformity assessment.
Keep copies of the originals, modifications and supplements of the technical documentation, the declaration of conformity and the certificates. These documents should be readily available in the event of inspections by the MHRA or the competent authority.
Submitthe documents that ensure the conformity of the device
Immediately inform the foreign manufacturer of suspected incidents, complaints and reports received from health professionals, patients and users.
Cooperate with the MHRA or relevant authorities for any corrective and preventive action taken to mitigate or eliminate any identified risks posed by the devices, or communication.
Maintain samples or have access to the products or their documentation, in order to provide them to the MHRA or relevant authority, upon request.
Terminate the contract with the manufacturer of the device in case of non-compliance with the applicable regulations.
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