Person Responsible for Regulatory Compliance (PRRC) According To MDR Article 15
The EU Regulation on Medical Devices (MDR - (EU) 2017/745) requires in Article 15 that each manufacturer of medical devices as well as each authorized representative has a Person Responsible for Regulatory Compliance (PRRC). This function includes the responsibility for both: the regulatory conformity of devices and the compliance with processes defined in the quality management system, under which the devices are manufactured, before a device is released.
Manufacturers, importers, distributors and EU representatives of medical devices and employees, who will be appointed to this position and their deputy:
- Clinical Affairs Manager
- Consultants
- Managing Director
- Regulatory Affairs Manager
- Quality Management Manager
- Introduction of MDR
- Person responsible for regulatory compliance (PRRC) according to Article 15 - requirements of the new role
- Documentation on the responsible person – Proof of Competences
- Registration of the responsible person (Eudamed)
- Tasks: verification of product conformity, TD, vigilance activities and PMS
- Reporting obligations:
- Post-market monitoring (PMS) – plans and required reports
- Reporting of serious incidents and field safety corrective actions
- Reporting of trends and Management review
- Clinical investigations: declaration for test products
- Availability: special provision for micro, small and medium-sized enterprises
- Responsible person& authorized representatives
- Liability and dealing with deviations
- Workshop
- Examination
The PRRC shall be responsible for ensuring that the conformity of the devices is appropriately checked, the technical documentation and the EU declaration of conformity are drawn-up and keep up-to-date, and the post-market surveillance obligations are complied within accordance with Article 10(10), as well as to ensure reporting of serious incidents. After an introduction to the EU legal framework, the necessary requirements for expert knowledge and the duties associated with the new function as PRRC will be presented by the instructor.
This seminar addresses internationally valid standards. It is a single training.
TÜV SÜD Academy certificate of attendance