The MHRA website provides all the details of a UK Responsible Person and the responsibilities of a UK Responsible Person are detailed in the SI 618/2002 as amended.
Expert Regulatory Consultant
Regulatory Consultants help manufacturers deliver their projects to get new devices on market and have handled experience in a variety of subject areas for device manufacturers with expertise in registering with the MHRA.
Umbilicus is NOT a Regulatory Consulant but we work with a number of expert consultants with a wide variety of experience to help companies meet the MHRA requirements for placing medical devices on the market in Great Britain.
How it works
There are two key documents:
-
- the agreement between the manufacturer and the appointed UKRP
-
- Letter of designation authorising the UKRP to act on behalf of the manufacturer
The UKRP Agreement and the Letter of designation are separate and distinct documents. The UKRP Agreement includes the roles and responsibilities of the UKRP with conditions as agreed by both parties. The Letter or Designation is a standard text provided by the MHRA to be printed on the manufacturer’s letterhead. The Letter of Designation must be uploaded in the MHRA database.
Steps for Appointing a UK Responsible Person (UKRP)
All details about the UKRP‘s responsibilities are available on the MHRA website and in the SI 618/2002 as amended.
A summary of the duties of a UKRP include:
- Ensuring technical documentation and conformity declaration are available
- Ensuring that an appropriate conformity assessment procedure has been followed by the manufacturer
- Holding copies of technical documents (e.g. declaration of Conformity and Certificate) for MHRA inspections
- Reporting incidents, complaints, and user feedback to the manufacturer
- Liaison with the manufacturer about Corrective & Preventive Actions (CAPA)
- Responding to any MHRA queries e.g. provision of samples, if requested
- Cooperating with the MHRA for risk mitigation actions
- Maintaining access to device samples for MHRA requests
- Registering devices with the MHRA before devices are placed in the UK market
- Terminating agreements in case of non-compliance
- Informing the MHRA about agreement termination
Labelling
For UKCA marked products, the UK Responsible Person details, i.e. name and postal address, are required on the label, the outer packaging and also on the instructions for use for every medical device and IVD which is marketed in the UK under the agreement.
Expiration and renewal
The expiration dates for service agreements between manufacturer and UKRP are actively monitored by MHRA and the renewal process should be initiated well in advance to ensure its renewal and continuity before the expiration date.
The registration must be renewed initially one year after being granted and thereafter, every two years. It is essential that this happens.
The manufacturer liaises with Umbilicus as UKRP to ensure that their PMS procedure is compliant.
The UKRP also assists the manufacturer with continued compliance to any new amendments made to the MHRA’s Medical Device Regulations.
Technical documentation
Upon agreement for any new product, Umbilicus will review the technical file for the product to ensure that the documentation supplied is compliant with MHRA regulations. This is an essential step in the compliance process. We will advise you of any compliance issues with the documentation and advise appropriate corrective action. Remediation and updating of the technical documentation will be the manufacturer’s responsibility prior to acceptance of the product by the UKRP.