Person Responsible for Regulatory Compliance (PRRC)
An introduction to PRRC requirements under the EU MDR
What is a PRRC?
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A Person Responsible for Regulatory Compliance (PRRC) is an individual or group of individuals nominated by a medical device manufacturer to take overall responsibility for the regulatory activities of that organisation.
Most manufacturers will need to have their own PRRC, although the MDR does state that micro and small enterprises may use an external PRRC assuming that certain conditions (discussed below) are fulfilled.
Rules relating to PRRC are outlined in Article 15 of the EU MDR.
What are the specific responsibilities of a PRRC under the MDR?
MDR Article 15 states that specific responsibilities for PRRCs include:
- Ensuring that MDR conformity of the devices is appropriately checked before a device is released
- Confirming that all medical device technical documentation and any Declarations of Conformity are drawn up and kept updated
- Checking that Post-Market Surveillance (PMS) obligations are complied with in accordance with MDR Article 10 (10)
- Ensuring that reporting obligations referred to in MDR Articles 87 to 91 are fulfilled
- Issuing, in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV.
If more than one PRRC is associated with an organisation, the responsibilities of each PRRC must be planned in advance and clearly outlined in the company’s Quality Management System (QMS).
What are the required qualifications for PRRCs under the MDR?
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Unless a company meets the definition of a small or micro company, the Person Responsible for Regulatory Compliance must be substantively employed by the medical device manufacturer. The MDR outlines required qualifications for PRRCs as follows:
- a diploma, certificate or other evidence of formal qualification, in law, medicine, pharmacy, engineering or another relevant scientific discipline, PLUS at least one year of professional experience in regulatory affairs or in Quality Management Systems relating to medical devices
- OR four years of professional experience in regulatory affairs or in Quality Management Systems relating to medical devices.
Therefore the MDR enables PRRCs to become sufficiently qualified as a result of a technical or scientific qualification plus limited direct experience, or as a result of more significant direct experience in the industry alone.
Because it may be beyond the means of small and micro companies to meet these requirements, the MDR enables such companies to draw upon a PRRC from outside their organisation under set circumstances.
What provisions are made for small and micro companies?
Small and micro companies, as well as Authorised Representatives of non-EU manufacturers, do not need to have a PRRC who is substantively employed by the organisation. They must however have an appropriately-qualified PRRC “permanently and continuously” at their disposal. The nominated PRRC must meet the above qualification requirements.
This rule means that smaller companies can avoid the challenges, financial and otherwise, of sourcing appropriately qualified PRRCs as permanent employees. Many smaller companies therefore use external contract PRRCs to help meet the requirements in MDR Article 16.
What other PRRC requirements must companies meet under the MDR?
MDR Article 16 requires that PRRCs shall suffer no disadvantage within the manufacturer’s organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation. This provision is necessary because the proper conduct of a PRRCs duties may, on occasion, run contrary to the direct commercial interests of the business (for example, by restricting sale of a device).