Presented by
Management Forum
The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course
This one day course will cover the role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the implementation of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Device Regulation 2017/746. The course will review Article 15 from the regulation in detail to enable understanding of the intent of each requirement. It will also present the UK Medical Device Regulation requirements and discuss the proposed Qualified Person role with current information.
19 September 2023
from £549
- Format: Live online
- CPD: 6 hours for your records
- Certificate of completion
Overview
This one day course will focus on the role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the implementation of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Device Regulation 2017/746. The course will review Article 15 from the regulation in detail to enable an understanding of the intent of each requirement. It will also present the UK Medical Device Regulation requirements and discuss the proposed Qualified Person role with current information.
Integration of the PRRC role into the Quality Management System will be discussed with real-world examples used throughout the day. In addition, the provision of the service by third parties will be investigated including how to support all requirements whilst being remote from the manufacturer. A case study looking at who should be a PRRC and a final scored assessment will also be included.
This is an excellent opportunity to understand the importance of the PRRC role and its place in your organisation.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
Benefits of Attending
- Understand the role and responsibilities of the PRRC
- Identify ways of incorporating the PRRC role into your organisation and Quality Management System
- Compare the EU PRRC role with the proposed UK MDR Qualified Person role
- Gain a clearer understanding of the PRRC role for those considering whether they should undertake this
Who Should Attend
- Quality Managers/Specialists
- Regulatory Affairs/Managers
- Start-up organisations with a need to understand where the PRRC role is required
- Compliance Engineers
- Those considering undertaking the PRRC role
The The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR course will cover:
Welcome and Introductions
- Objectives for the day
- Introductions - what do you want from the day?
Origins of EU PRRC/UK QP Role
- Which Competent Authority drove the need?
- Why was the role introduced?
- What was the gap that needed to be filled?
Ariticle 15
- Requirements
- Qualifications
- Importers, Distributors
- Systems and Procedure Packs
- Authorised Representatives
UK MDR 2002
- What does the response from the UK tell us?
- Differences from the EU
PRRC Roles and Responsibilites
- The conformity device meets regulatory standards
- Technical documentation is established and maintained
- Post-market surveillance activities are compliant with regulations
- Incidents are recorded and reported and field safety corrective actions are implemented
- A statement has been issued in case of investigational devices (MDR) or IVD devices intended for use in interventional clinical effectiveness studies (IVDR)
Case Study: Who Should be a PRRC?
PRRC Quality Management System Integration
- Job descriptions
- SOP to cover appointment and cover
- Proof for audits etc
Provision of PRRC Service by Third Parties
- What does the regulation state?
- How does an organisation qualify as small or medium?
- Practicalities of access for third parties
Overview of Key Take Home Points
Final Score Assessment
Assessment Review Workshop
- A short questionnaire to aid the learning process
Q & A and Course Round-up
Book The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR Live online training
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
19 September 2023
Live online
09:00-16:45 UK (London) (UTC+01)
10:00-17:45 Paris (UTC+02)
04:00-11:45 New York (UTC-04)
Course code 14165
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 15 Aug
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
