MDR: Person Responsible for Regulatory Affairs

Miriam Schuh

Article 15 of the MDR defines requirements for the "person responsible for regulatory compliance" (PRRC), specifying that manufacturers of medical devices must have at least one person "within their organization" who "possesses the requisite expertise in the field of medical devices."

The PRRC is "more" than just a "Safety Officer 2.0." The PRRC's responsibilities for ensuring compliance with regulations go far beyond the duties of a safety officer

The guidance document 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) contains an in-depth discussion of Article 15 of the MDR and the definition of "organization."

The guidance document states as follows:

"The person responsible for regulatory compliance (PRRC) appointed would need to be an employee of the organization. Organizations with more than one legal manufacturer under the parent company would need to ensure that each legal manufacturer has its own PRRC."

The requirement established by Article 15 of the MDR to have at least one PRRC available within the organization applies to each individual "legal manufacturer." In accordance with Article 2 No. 30 of the MDR, a "manufacturer" is a "natural or legal person who manufacturers or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark."

Accordingly, in cases where the same corporate structure includes multiple manufacturers as defined in Article 2 No. 30 of the MDR, each of these manufacturers would have to have its own PRRC available within its organization.

[March 2020]