Manufacturers who need to appoint a person responsible for regulatory compliance (PRRC)

As per the Regulations Article15(1) and as interpreted by the MDCG Guidance 2019-7, manufacturers are required to have available within their organisation at least one PRRC with proper expertise in the field of medical devices or in vitro medical devices, as applicable, in the European Union. This is valid for enterprises which employ at least 50 persons and whose annual turnover and/or annual balance sheet total exceeds EUR 10 million.

The MDCG Guidance 2019-7 explains that “within their organisation” means that the PRRC appointed to larger manufacturers would need to be an employee of the organisation. In cases where an organisation has more than one legal manufacturer under the parent company, it would need to ensure that each legal manufacturer has its own PRRC.

In the case of micro and small manufacturers, defined by the Commission Recommendation 2003/361/EC as enterprises which employ fewer than 50 persons and whose annual turnover and/or annual balance sheet
total does not exceed EUR 10 million, the PRRC are required to be “permanently and continuously at their disposal” as opposed to “within their organisation”. Therefore, micro and small manufacturers are permitted
to designate an external subcontractor as their PRRC.

The MDCG Guidance 2019-7 interprets that the micro or small enterprise may subcontract the responsibilities of a PRRC to a third party, as long as the qualification criteria are met, and the manufacturer can demonstrate and document how they can meet their legal obligations. Therefore, in these cases, the PRRC may be part of an external organisation with which the manufacturer has established a contract laying down provisions to ensure the permanent and continuous availability of that party. The contract
should also mention the relevant person’s qualifications demonstrating compliance with points a) or b) of Article 15 (1).

Each micro and small manufacturer is supposed to evaluate its needs and define in the contract with the subcontracted PRRC how the availability requirements are intended to be met (e.g. two PRRCs or deputies might be needed to cover the availability obligations, or the contract could state to inform the client if the PRRC will be out of contact for more than two business days etc.).

This is an excerpt from the  BSI medical devices white paper, Person responsible for regulatory compliance (PRRC) - MDR/IVDR Article 15. To browse our collection of medical device white papers, please visit the Insight page on the Compliance Navigator website.