Course Overview
The Person Responsible for Regulatory Compliance (PRRC) role was created under article 15 of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). However, the exact details of the role such as qualifications required, tasks, liability and administrative elements have been unclear for many.
Led by Anne Jury, this course will provide you with clarity on the role and all its responsibilities, so your organisation is compliant. You will examine key topics such as qualifications, appointment, registration, tasks, compliance and admin. It is designed for professionals who are a PRRC or considering becoming one for their organisation. It is also beneficial for management to attend so they fully understand the role of the PRRC.
Key Learning Objectives
- Review the regulation and understand why the role was set up as part of the MDR
- Examine the qualifications required and how to document this
- Discuss the important elements of appointing a PRRC such as having an agreement / job description
- Registration of the PRRC under Eudamed
- Review the responsibilities of a PRRC of a manufacturer and Authorised Representative and analyse the tasks needed to perform these responsibilities
- Discuss the liability of the PRRC – what does this mean for me?
- In groups examine real-life scenarios to fully cement the course learnings
- Direct access to an expert trainer
- Interactive and engaging sessions
- Access to the Educo Life Sciences Training Portal
- Unlimited access to the recordings for 2 weeks after the session
To enrol on the course, click here.