Responsible Person (PRRC and UKRP)
Depending on your jurisdiction of deployment, you may need to appoint responsible persons across these jurisdictions.
Person responsible for regulatory compliance (PRRC)
A nominated PRRC is a mandatory requirement for all manufacturers and an Authorised Representative under EU MDR and IVDR. Importers, distributors and other persons (if acting as a manufacturer as per Article 16 of MDR/IVDR) will need to appoint a PRRC. The point of a PRRC is to provide confirmation to European Authorities that a professionally qualified Quality and Regulatory expert is available as a key contact within the organisation if needed.
Regulations permit medical device manufacturers that are located outside the EU to hire a PRRC outside the EU. However, manufacturers located within the EU should have a PRRC located within the EU.
UK Responsible Person (UKRP)
The requirement of UK Responsible Person (UKRP) as per UK MDR, is applicable to Medical Device manufacturers who are based outside the UK. The UK does not require a PRRC to be appointed; however, it requires a “Responsible Person” based in the UK whose responsibilities are similar as of an Authorised Representative in the EU.
Best Practices
Align with internationally recognised standards.
PRRC requirements including the necessary qualifications are detailed in EU MDR / IVDR Article 15 and MDCG 2019-7.
Similarly, UKRP requirements are detailed on the MHRA website.
UKRP RESPONSIBILITIES
Check documentation - Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
Registration - Register each product with the MHRA (plus additional fees).
Keep available copies of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA.
Respond to requests - In response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device.
Forward to the manufacturer any request by the MHRA for samples, or access to a device, and ensure that the MHRA receives the samples or has been given access to the device.
Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
Vigilance - Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
Legal - Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the MHRA and, if applicable, the relevant notified body of that termination.
Please do not get confused between PRRC and UKRP, as these roles are intended for totally different market access and are not linked with each other in any way. You may need to appoint both depending on where your company is located.
Case Study
How Hardian solves the problem.
Hardian Health can act as a competent and qualified PRRC and UKRP, depending on your needs. Several of our clients, including Icometrix and Cibiltech opt to use our Responsible Persons Service as part of our regulatory offerings. With Hardian as your nominated Responsible Person, you can be sure that your international needs are met.
Get in touch
Get in touch to see how Hardian can act as your PRRC or UKRP.