The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR
This one day course will focus on the role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the implementation of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Device Regulation 2017/746. The course will review Article 15 from the regulation in detail to enable an understanding of the intent of each requirement. It will also present the UK Medical Device Regulation requirements and discuss the proposed Qualified Person role with current information.
Integration of the PRRC role into the Quality Management System will be discussed with real-world examples used throughout the day. In addition, the provision of the service by third parties will be investigated including how to support all requirements whilst being remote from the manufacturer. A case study looking at who should be a PRRC and a final scored assessment will also be included.
This is an excellent opportunity to understand the importance of the PRRC role and its place in your organisation.
Upcoming start dates
Suitability - Who should attend?
Benefits of Attending
- Understand the role and responsibilities of the PRRC
- Identify ways of incorporating the PRRC role into your organisation and Quality Management System
- Compare the EU PRRC role with the proposed UK MDR Qualified Person role
- Gain a clearer understanding of the PRRC role for those considering whether they should undertake this
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