PRRC – A New EU Requirement

Proposal Description: The EU MDR 2017/745 and EU IVDR 2017/746 introduced a new key person to the regulatory landscape. This person is responsible to ensure regulatory, quality and clinical compliance in the organization. During this session, members from the European TEAM-PRRC will share key takeaway from the initial implementation of this requirement and update the attendees about the duties and responsibilities connected to this role. Also, the liability of this person will be discussed by sharing legal input reflecting the expectations of the various EU Member States.

Agenda Outline:

7:00-8:30 am
All Workshop Registrants: Registration, Continental Breakfast & Welcome
08:30 am     Workshop Start

08:30 – 08:40 am     Opening of the workshop and introduction of the speakers (Dr. Bassil Akra)

08:40 – 09:10 am     Introduction to Article 15 Requirements (Dr. Bassil Akra)

09:10 -10:30 am     Quality Management System: Duties and Responsibilities of the PRRC

10:30 am – 11:00am     Workshop Refreshment Break

11:00 am – 12:00 pm     Technical Documentation: Duties and Responsibilities of the PRRC (Francis Decker)

12:00 – 12:30 pm     PMS and Vigilance Part 1: Duties and Responsibilities of the PRRC (Erik Vollebregt)

12:30 – 1:30 pm     Workshop Lunch

01:30 – 02:30 pm     PMS and Vigilance Part 2: Duties and Responsibilities of the PRRC (Erik Vollebregt)

02:30 – 03:00 pm     Clinical Requirements: Duties and Responsibilities of the PRRC (Danielle Giroud)

03:00 – 03:30 pm     Liability: How to manage potential liability and structure the PRRC mandate for this? (Erik Vollebregt)

03:30 – 04:00 pm     Q&A Session (All speakers)

04:00 pm     Workshop Ends