Medical Device Regulation (2017/745) & In Vitro Diagnostic Regulation (2017/746) Article 15 introduced the following requirement:

“Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.”

Within Article 15(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 that employ at least 50 persons and whose annual turnover and/or annual balance sheet total exceeds EUR 10 million.

In the case of micro and small manufacturers, defined by the Commission Recommendation 2003/361/EC as enterprises that 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.

MDCG 2019-7 - Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC).