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.
★★★★★ "I accomplished a better understanding on the role of the PRRC. Very knowledgeable [speaker] with a g... more (8)"
4 March 2026
+ 21 September 2026 »
from £649
- Format: Live online
- CPD: 6 hours for your records
- Certificate of completion
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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 part of our range of Medical Devices training courses
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
This 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
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
4 March 2026
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 16060
- GBP 649 749
- EUR 909 1,049
- USD 1,043 1,199
Until 28 Jan
- 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 September 2026
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 16345
- GBP 649 749
- EUR 909 1,049
- USD 1,043 1,199
Until 17 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; and apply only when booking multiple delegates on the same date.
Reviews of IPI's The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR training course
I accomplished a better understanding on the role of the PRRC. Very knowledgeable [speaker] with a good presentation style.
May 22 2025
Adrian Dunleavy 
UK Quality & Regulatory Manager, Freudenberg Performance Materials LP
Jan 23 2025
The content was structured logically and could be followed easily. The atmosphere was friendly and inviting to participate/ask questions. [Speakers were] competent, very helpful, friendly and patient with us.
Elena Louisa Lange 
Quality Management Officer, Farstar medical
Jan 23 2025
The training successfully addressed Learning more about the role and responsibility of the PRRC. Content and presentation all good. Not too formal, not too informal. Just right. Speakers [have] Great knowledge about the subject.
Wessel Nomen 
PRRC/Engineer, Enraf-Nonius
Sep 22 2025
I was hoping to gain a better understanding of the role of the PRRC, in particular the expectations placed upon them. This was achieved. Overall a very good training session.
Chris Hooper
Group Quality Manager, Dermal Laboratories Ltd
Jan 23 2025
Excellent content, presentation and speaker.
Sandra Frenkel 
RA Device, Nueroderm
Jan 23 2025
Good content [particularly liked] MDR requirements.
Ziva Mesika
VP RA, NeuroDerm
Jan 23 2025
Good Content. Presentation/Speakers - 5* Very good.
Mariusz Dabrowski
Quality, Regulatory & Logistics Officer, Eurobio Scientific UK
Sep 24 2024
another excellant [sic] webinar from IPI
Toni Day
Senior Director Regulatory Affairs ONA & New Ventures, OrganOx Ltd
United Kingdom
- Advanced Healthcare Ltd
- Anthony Nolan
- Bedfont Scientific Ltd
- Dermal Laboratories Ltd
- Eurobio Scientific UK
- FANNIN HEALTHCARE LTD
- Freudenberg Performance Materials LP
- Genedrive Diagnostics Ltd.
- Grifols UK
- Mayborn Group
- Olympus (UK) Ltd
- OrganOx Ltd
- PA Consulting
- Phillips medisize
- Vectura Ltd
- Xiros Ltd
Israel
- NeuroDerm
- Neuroderm a Mitsubishi Pharma Group Company
- Neuroderm.com
- Nueroderm
Denmark
- Ferring Pharmaceuticals
- Ferring Pharmaceuticals A/S
Germany
- AJW Technology Consulting GmbH
- Farstar medical
Italy
- Angelini Pharma SpA
- Mastelli
France
- Nemera
Netherlands
- Enraf-Nonius
Poland
- LiNA Medical Polska Sp. z o.o.
United States of America
- Hydrafacial LLC
Run The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR Live online for your team
1 day
Typical duration
Pricing from:
- GBP 500
- 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:
