Every manufacturer operating under Regulation (EU) 2017/745 is required to designate a Person Responsible for Regulatory Compliance. This template formalises that appointment.
Under Article 15 of Regulation (EU) 2017/745, the PRRC must meet defined qualification requirements and hold clearly documented responsibilities within the organisation. This template covers the formal designation of the PRRC, their authority, qualifications, and core obligations — including oversight of device conformity, maintenance of technical documentation, review of post-market surveillance activities, and fulfilment of vigilance reporting obligations.
Documented correctly, the PRRC appointment demonstrates to competent authorities and Notified Bodies that regulatory oversight within the organisation is assigned to a qualified, accountable individual.
This template is built by experienced regulatory professionals, ensuring the appointment reflects every requirement of Article 15.
Price: $50
