The presence of at least a Person Responsible for Regulatory Compliance (PRRC) is one of the new regulatory obligations introduced by the Regulation (EU) 745/2017 for Manufacturers and European Representatives of medical devices marked according to the Regulation.
The presence of at least a PRRC is in any case recommended also for Manufacturers and European Representatives of medical devices marked according to the previous Directive 93/42/EEC and who benefit from the grace period up to May 26th, 2024.
The PRRC is responsible for ensuring the conformity of medical devices with the quality management system, the update of technical documentation and EU declaration of conformity, the fulfilment of obligations relating to vigilance and post-marketing surveillance, and the fulfilment of obligations relating to clinical investigations in case of investigational devices.
The PRRC shall have:
- a formal qualification in law, medicine, pharmacy, engineering or another relevant scientific discipline and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices
- or alternatively four years of professional experience in regulatory affairs or in quality management systems relating to medical devices without any particular formal qualification.
The PRRC shall be available permanently and continuously and must have decision-making autonomy in relation to his/her own competences and responsibilities. It is also possible to assign the role of PRRC to more than one person, provided that each has the required qualifications and that the respective competences and responsibilities are established in the respective appointment forms (so-called joint and several liability is excluded).
The role of PRRC can be delegated to a third person outside the company only for SMEs with less than 50 employees and annual turnover less than € 10M.
The identity of the PRRCs should be reported by the company in the EUDAMED.
Regulatory Pharma Net (RPN) is available to provide your company with any updates on the medical device regulatory framework and to assist on all regulatory needs related to medical devices.
Feel free to contact us at info@regulatorypharmanet.com