UKRP stands for United Kingdom Responsible Person. Medical Device manufacturers located outside the United Kingdom (UK) and without any local business offices, shall appoint a United Kingdom Responsible Person (UKRP), on their behalf, as a pre-requisite for device registration and launch of the device in the United Kingdom.
What is the Legal Basis for a UKRP?
Pre-requisites to appoint a UKRP, responsibilities of a UKRP and other related information is defined in the UK MDR 2002.
When should a Medical Device Manufacturer Appoint a UKRP?
Medical device manufacturers with already marketed devices in the UK should appoint a UK Responsible Person by 1st January 2021. The device manufacturers with an intention to place their device in the UK market, shall appoint a UKRP before the device registration. The UK Responsible Person shall register the devices with the MHRA.
What are the Responsibilities of a UKRP?
The UK Responsible Person is responsible for below activities:
- Shall act on foreign manufacturer’s behalf and register the devices with the MHRA, before they are placed in the UK market
- Shall ensure that all the device technical documentation and applicable declaration of conformity documents are in place for the device in scope and that the conformity assessment has been completed by the device manufacturer
- Shall maintain copies of the original, amendment and supplements of technical documentation, the declaration of conformity and certificates. These documents should be readily available in case of the MHRA inspections.
- Shall be able to present the documents that ensure conformity of the device
- Shall inform the foreign manufacturer immediately about the suspected incidents, complaints and reports received from healthcare professionals, patients and users
- Shall cooperate with the MHRA for any corrective and preventive actions taken for mitigation or elimination of any identified risks posed by the devices
- Shall either maintain samples or have access to the devices, in order to provide to the MHRA, on request. If not, UKRP shall forward the MHRA request for sample or access
- Shall terminate the agreement with the device manufacturer in case of non-conformities with applicable regulations
- Shall keep the MHRA and relevant Notified Body informed, about the termination of agreement, if applicable
Who can Act as a UKRP?
Any third-party entity or an importer or distributor can act as a UK Responsible Person on foreign manufacturer’s behalf. The appointed UK Representative shall register with the MHRA.
What are the Labeling Requirements in the Context of UKRP?
The name and address of the United Kingdom Representative shall be included on the label of a UKCA marked device, w.e.f. 1st, January 2021.
For more information on UKCA marking of device or for end-to-end UKRP services, reach us at firstname.lastname@example.org.