Person Responsible for Regulatory Compliance (PRRC)
Under the MDCG Guidance 2019-7, we can provide micro or small enterprises, a contractual PRRC service to meet their legal obligations (Article 15).
As your PRRC, we can provide the following services:
- Ensure the compliance of released devices, as well as the post-market surveillance (PMS) and vigilance activities concerning those devices (MDR recital 34, IVDR recital 33)
UK Responsible Person (UKRP)
Where a manufacturer is not established in the UK, they must appoint a UK Responsible Person to register and act on their behalf. Manufacturers must comply with relevant product marking and conformity assessment requirements for medical devices and register with MHRA.
As your UK RP we can provide the following services:
- MHRA registration
- 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
- Keep available a copy 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
- 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
- Comply with any request from the MHRA to provide such samples or access to the device (as available). If not available, communicate to the manufacturer any request from the MHRA to provide such samples or access, and communicate to the MHRA whether the manufacturer intends to comply with that request
- 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
- 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 appointed
