The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) In-house Training

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.

Need help?

Format: Live online
CPD: 6 hours for your records
Certificate of completion

Download Print

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

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

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