Course overview

This course will enable you to be ready for the IVDR to come into force. It will cover all of the key topics and includes areas of responsibility of those taking on the Person Responsible for Regulatory Compliance role.

This course will cover:

• An overview of the IVDR regulations
• Regulatory affairs throughout product development
• Risk classification of IVDs
• Conformity assessment pathways for each device class
• IVDR technical documentation requirements including labelling and UDI
• Overview of PRRC responsibilities including performance studies
• Responsibilities of economic operator, including key obligations and registration
• QMS requirements
• Classification and Notified Body approval
• Overview of PMS and Vigilance requirements 

Benefits to delegates

• Be able to guide your organisation through implementation of the IVDR
• Be confident you understand the requirements
• Be confident you will be ready for IVDR compliance
• Learn from experts in the field   
• Learn by doing - participate in case studies and interactive sessions 
• Build a network and benefit from peer support

Programme

Presenters

Simon Richards Director, Division Regulatory Affairs, Abbott	Stephen Lee Director, Diagnostics Regulation, ABHI	Petra Zoellner Senior Manager, MedTech Europe
Tom Clarke Regulatory Affairs, Abbott	Gillian Morgan Director, Sestria Ltd	Fiona Gould

Suitable for

Anyone working in IVD regulatory affairs in Europe or wanting to work in IVD Regulatory Affairs who have some experience of regulatory affairs or who have taken the Essentials of IVD regulatory affairs course, particularly individuals who are:

• Taking on the role of Person Responsible for Regulatory Compliance
• Responsible for preparing the organisation for compliance with the IVDR
• Responsible for liaising with an external PRRC for their company
• Consultants advising companies on preparedness for IVDR or fulfilling the PRRC role 

Pricing

Standard

• Member: £825 + VAT
• Non-member: £1,020 + VAT

Discounted places

A limited number of discounted places are available at the rates below. Please email us at meetings@topra.org for a discount code before making your booking.

Discounted prices

• Those working for regulatory agencies, government agencies or academic institutions
  • Members: £618.75 + VAT
  • Non-members: £765 + VAT
Those working for charities, patient groups or in full-time education
• Members: £412.50 +VAT
• Non-members: £510 +VAT

Terms and conditions

Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.