Person Responsible for Regulatory Compliance

• Brief introduction to the MDR and IVDR
  • A short background to the regulation of medical devices and IVDs in the EU and how the ‘new’ regulations came about. What the main differences are between the old Directives and the new Regulations.
• Article 15 (MDR)
  • Article 15 defines the requirements for Person Responsible for Regulatory Compliance (PRRC). We will go through all of the requirements detailed in Article 15, as a prelude to a more detailed understanding of the requirements, line by line later in the course.
• Article 15 (IVDR) – differences
  • Article 15 exists in both the Medical Device ‘MDR’ and the Diagnostics ‘IVDR’. The requirements are highly similar, but there are some differences to point out.
• Important Definitions & Understanding the Vernacular
  • The language used in the Regulations is not always helpful to the novice or inexperienced person. We will go through important definitions to help provide a full understanding of the requirements and provide an explanation of the language and terms used in the regulations.
• Personal liabilities
  • The PRRC is an important and responsible position that is specifically required in the regulation. The role is often fulfilled by a named individual but can be shared by more than one person. This section explains where the liabilities lie for the responsibilities of the PRRC.
• Qualification of personnel for PRRC Vs ability to fulfil the role
  • Article 15 details exactly what qualifications and experience are required for the person fulfilling the role of PRRC. There is more than one route available, yet neither route guarantees an individual’s ability to be able to carry out the role with competence. One of the main reasons for people to learn more on this course.
• Understanding the requirements, line by line
  • A detailed line by line analysis of all of the requirements for the PRRC, what they mean and practical approaches in meeting the requirements.

• Day 1 Review
  • A brief recap of the main points from Day 1.
• Understanding the requirements, line by line (continued)
  • A continuation of the detailed line by line analysis of all of the requirements for the PRRC, what they mean and practical approaches in meeting the requirements that began during Day 1.
• Practical Approaches
  • The practical approaches are integrated into the detailed line by line analysis.
• MDCG (Medical Device Coordination Group) guidance document
  • The MDCG is an important advisory body to the European Commission. The MDCG has produced a large number of important guidance documents assisting in the understanding of the requirements of the MDR and IVDR. Here, we go through the MDCG guidance document for the PRRC.
• A Notified Body Perspective
  • BSI, one of the leading Notified Bodies in the EU has produced a White Paper on PRRC. Given that Notified Bodies have the responsibility and authority to review each manufacturer’s compliance to Article 15, it is important to understand how the regulators see the issues. BSI’s whitepaper provides an overview of the requirements together with the practical considerations to be made, from a Notified Body perspective.
• Team PRRC
  • Team PRRC describes itself as a “non-profit European Association dedicated to the new profession of ‘Person responsible for regulatory compliance’ (PRRC)”. The Association is a significant resource for information with further resources available to members. A brief introduction to Team PRRC is given.
• Reading List
  • A reading list for further self-directed is provided.
• Close

100% portfolio assessment:

• Sub-element 1: Short essay answers to questions
• Sub-element 2: Assessment of involvement