1. Concept of the UK Responsible Person
• Be appointed by a non-UK manufacturer
• Perform the appropriate responsibilities on behalf of the manufacturer
• The specific tasks include the registration of medical devices
• The role can be performed by an UK importer, but it is not mandatory
• The responsibilities are similar to those of the European Authorized Representative under this directive - please refer to the MHRA Guidance for details
• Grace period for appointing the UKRP - the same as the grace period for device registration
• The symbol of UKRP has not been published
• PRRC is not required (according to the MDR and IVDR)
2. Responsibilities of the UK Responsible Person
a) Ensure that the declaration of conformity and the technical documents are drafted and, where applicable, the appropriate conformity assessment procedures are implemented by the manufacturer.
b) Keep the copies of the technical documents, the declaration of conformity, and the relevant certificates (if applicable), including any modifications and supplements, for the MHRA to check.
c) Provide the MHRA with all information and documents required to demonstrate the device conformity upon the request by MHRA.
d) Provide the MHRA with the device samples, or allow the MHRA to access the device that the UK Responsible Person can sample or access, or forward the MHRA’s sample or access request to the manufacturer when the UK Responsible Person has no right to access or sample.
e) Cooperate with the MHRA to take any preventive or corrective actions to eliminate or (if not possible) mitigate the risks posed by the device.
f) Immediately inform the manufacturer of the complaints from the health care professionals, patients and users, as well as the reports of suspected events related to the designated device.
g) Terminate the legal relationship with the manufacturer if the manufacturer acts in violation of its obligations under the applicable regulations, and inform the MHRA and the relevant notified bodies of the termination (if applicable).
3. Device registration
After January 1, 2021, each device must be registered with the MHRA before it can be put on the UK market, whether it bears a UKCA mark or CE mark.
|
Product class |
Registration deadline |
|
Active implantable medical devices Class III medical devices Class IIb implantable medical devices IVD List A |
April 30, 2021 (4 months) |
|
Class IIb non-implantable medical devices Class IIa medical devices IVD List B Self-test IVDs |
August 31, 2021 (8 months)
|
|
Class I medical devices General IVDs |
December 31, 2021 (12 months) |
Note: the 12-month grace period is not applicable to the manufacturers of Class I devices and general IVDs that need to be registered with the MHRA at present.
Custom devices - the schedule is based on the product classification in the table.
