PRRC and related Responsibilities
Article 15 of the Medical Devices Regulation (EU) 2017/745 (MDR) requires that every medical device manufacturer and every EU authorized representative have at least one person responsible for regulatory compliance.
The Responsible Person replaces the Medical Device Safety Officer but has significantly more tasks and areas of responsibility than the Safety Officer previously had. As the person responsible for the conformity of the medical devices supplied, you should be thoroughly familiar with the requirements and obligations and implement them accordingly.
- Content
- Key Terms under Article 2 of the MDR
- Legal Framework
- Objectives and Structure of the MDR (Regulation 2017/745)
- Article 15 of the MDR – PRRC
- Responsibilities of the PRRC:
- Product conformity
- Technical documentation
- Post-market surveillance
- Vigilance
- Declaration for clinical investigations
- Overview of interfaces – PRRC and QMS
- PRRC of the EU Authorized Representative (MDR Article 15(6))
- Special provisions for small and micro-enterprises
- Registration of the PRRC
- EUDAMED
- Annex XI Part A and Annex VI Part A
- Safety Officer under Section 30 MPG vs. PRRC Vigilance
- Similarities and differences
- Sanctions and liability
- Article 113 of the MDR
- MPDG Sections 92 to 94 Penal provisions
- Your Benefits
- You will learn about the various responsibilities and requirements for medical device advisors.
- You will gain a comprehensive overview of liability and penalty issues.
- The certificate serves as proof of your qualification as a medical device advisor.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Manufacturers of medical devices and in vitro diagnostic devices
- Medical device consultants
- Sales representatives
- Regulatory affairs professionals
- Service staff
- Field sales representatives
- Professionals transitioning from other industries
