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

DUBLIN--(BUSINESS WIRE)--The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course" conference has been added to ResearchAndMarkets.com's offering.

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.

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

Key Topics Covered:

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?

Article 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 Responsibilities

• 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 appointments 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

Speakers:

Stuart Angell

Director

IVDeology Ltd

Stuart Angell, This MDTI expert 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.

For more information about this conference visit https://www.researchandmarkets.com/r/3k8cy4

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