Person Responsible for Regulatory Compliance (PRRC)
Compliance with European regulations has become progressively more complex, especially with the publication of the EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746).
With the new regulations, European regulators want to make sure companies always have a qualified regulatory expert at their disposal to ensure the company is meeting EU requirements.
Thus, a new role has been created called the Person Responsible for Regulatory Compliance (PRRC) referred to in Article 15 of the European MDR and IVDR.
About Person Responsible for Regulatory Compliance (PRRC)
What will you learn:
In this 1 day training you will learn what you need to know about the role as PRRC, which is mandatory for Medical and In Vitro Diagnostic Device Manufacturers. We will get knowledge of what the role covers and how this role should be implemented from a regulatory perspective. The course is aimed at individuals appointed PRRC or for economic operators that need a PRRC.
Content of the course:
- MDR/IVDR requirements for PRRC
- What does PRRC mean to the organizations throughout the medical device lifecycle including economic operators
- What are the qualifications needed
- What is the responsibility and authority
- How shall outsourcing of the role be managed
- What is the job description and work tasks according to the MDR/IVDR
- How to understand MDCG guidance and other guidance documents
Course Leader:
Anette Sjögren, PREVENTIA AB
Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force.
Language:
Course material is in English.
Presentation in English or Swedish (depending on the participants).