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.
24 January 2024
+ 21 May 2024, 24 September 2024 »
from £549
- Format: Live online, Classroom
- CPD: 6 hours for your records
- Certificate of completion
- An Introduction to the Medical Device Regulation
- Introduction to the In-Vitro Diagnostic Regulation (IVDR)
- The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR
- An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices
- Managing Competence within the Medical Device Industry
- An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices
- An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals
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:
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
Stuart Angell
Ivdeology
Stuart Angell is a joint director in his own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices focusing on the transition to the new IVD/Medical Device Regulations, MDSAP and ISO13485:2016.
He has over 15 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex list II products including technical documentation for EU and global submissions (FDA, Health Canada, TGA, Russia, Latin America). He has an excellent understanding of risk management, Post Market Surveillance (PMS) and vigilance.
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
24 January 2024
Live online
09:00-16:45 UK (London) (UTC+00)
10:00-17:45 Paris (UTC+01)
04:00-11:45 New York (UTC-05)
Course code 14306
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 20 Dec
- 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
21 May 2024
Classroom
London venue TBC
09:00-16:45 UK (London)
Course code 14308
Optional £265/€380/$435 per night
- GBP 649 749
- EUR 939 1,079
- USD 1,053 1,209
Until 16 Apr
- 1 day classroom-based training
- Optional accommodation - 1 night including breakfast, checking in the day before the course
- Meet presenters and fellow attendees in person
- Lunch and refreshments provided
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
24 September 2024
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 14307
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 20 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.
Germany
- AJW Technology Consulting GmbH
Poland
- LiNA Medical Polska Sp. z o.o.
United Kingdom
- Advanced Healthcare Ltd
