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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.

23 January 2025
+ 22 May 2025, 22 September 2025 »

from £549

Need help?  Enrol or reserve

Course overview

Attend this one-day course to gain a comprehensive understanding of the critical role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Device Regulation 2017/746.

In the evolving landscape of medical device regulation, understanding and complying with new roles and requirements is crucial for maintaining market access and ensuring patient safety. The introduction of the Person Responsible for Regulatory Compliance (PRRC) role mandated under the Medical Device Regulation (MDR) 2017/745 and the In-vitro Diagnostic Device Regulation (IVDR) 2017/746 has created a pivotal position within organisations, necessitating a deep understanding of its responsibilities and integration into existing systems.

This course is designed to address these challenges and provide participants with the necessary knowledge and tools to effectively implement the PRRC role within their organisations.

This comprehensive one-day course will delve into Article 15 of the regulation in detail, ensuring a thorough understanding of each requirement's intent. Participants will also be briefed on the UK MDR requirements and the proposed Qualified Person (QP) role, based on the latest information. 

A key focus will be the integration of the PRRC role into the Quality Management System, supported by real-world examples to illustrate practical applications. The course will explore the provision of PRRC services by third parties, addressing how to meet all requirements remotely from the manufacturer.

This course offers an excellent opportunity to grasp the significance of the PRRC role and its critical place in your organisation, equipping you with the insights and practical strategies to ensure compliance and regulatory success. 

This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

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?

This course is ideal for those seeking to understand the role of the Person Responsible for Regulatory Compliance (PRRC), and those currently holding or considering the PRRC designation within medical device companies, including:

  • Quality managers/specialists
  • Regulatory affairs professionals
  • Start-up organisations with a need to understand where the PRRC role is required
  • Compliance engineers
  • Medical device manufacturers
  • Those considering undertaking the PRRC role

Enrol or reserve

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.

More details

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

23 January 2025

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 14455

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 19 Dec

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Not ready to book yet?

for 7 days, no obligation

22 May 2025

Classroom
Rembrandt Hotel
London

09:00-16:45 UK (London)
Course code 14706
Optional £270/€351/$405 per night

  • GBP 649 749
  • EUR 939 1,079
  • USD 1,053 1,209

Until 17 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

View basket 

 
Not ready to book yet?

for 7 days, no obligation

22 September 2025

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 14944

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 18 Aug

View basket 

 
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; and apply only when booking multiple delegates on the same date.

United Kingdom

  • Advanced Healthcare Ltd
  • Bedfont Scientific Ltd
  • Grifols UK
  • Mayborn Group
  • OrganOx Ltd
  • Vectura Ltd

Israel

  • NeuroDerm
  • Neuroderm a Mitsubishi Pharma Group Company
  • Neuroderm.com

Denmark

  • Ferring Pharmaceuticals A/S

Germany

  • AJW Technology Consulting GmbH

Poland

  • LiNA Medical Polska Sp. z o.o.

Enrol or reserve

Run The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR Live online/Classroom for your team

1 day

Typical duration

Pricing from:

  • GBP 450
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy