Online Training | A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU and UK

Much has changed since the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR) were adopted in May 2017.

This course will bring you fully up-to-date on:

• the rephrased implementations
• the new guidelines
• role and output from the Medical Device Co-ordination Group (MDCG)
• recent medical device regulatory developments in the UK

It will also consider future developments and the evolving role of the EMA.

This course will provide an excellent opportunity to hear the latest developments from regulatory experts, and enable participants to discuss the implications of the regulations on working practices and the potential impact on future regulatory strategies.

Who should attend?

Medical Device and In-Vitro Diagnostic professionals from the following areas:

• Regulatory affairs
• Clinical studies
• Vigilance
• Post Market Surveillance
• Quality systems
• Technical Support and Business Development

Agenda

Welcome and introduction

• New features
• Key roles
• Key learnings

Overview of the current position with the MDR

• Where are we today?
• How have we got to this point
• The evolution of ‘Digital Medicine’ and its impact on the MDR

EU view from industry - Medical Devices

• What has been delivered
• What remains outstanding
• How will things progress
• Challenges and opportunities
• Notified Bodies and QMS

View from industry - IVDs

• What has been delivered 
• What remains outstanding
• How will things progress  - what are the transitional arrangements and how best to use them
• Challenges and opportunities
• Notified Bodies and Quality Mangement Systems (QMS) 

Notified Bodies (NBs) and Conformity Assessment Bodies (CABs) - Update on progress from an NB perspective

• How many Notified Bodies/CABs are there?
• Role of the Medical Device Co-ordination Group (MDCG)
• Nando (New Approach Notified and Designated Organisations) Information System
• Implications of the MDR, Brexit and the Covid Pandemic
• UK Approved Bodies/CABs
• Differences and similarities between Notified Bodies and UK Approved Bodies
• How is the Conformity Assessment process working

Combination products

• EU Pharmaceutical Products influence
• New role of the European Medicines Agency (EMA) / Committee for Medicinal Products for Human Use (CHMP)
• Implications of MDR:Article II7

UK Regulatory proposals for medical devices and IVDs

• IDAP and Innovation in the UK
• MHRA roadmap for international recognition and domestic legislation
• MHRA roadmaps for AI/SaMD and IVDs
• UK regulations on post-market activities
• Panel discussion

For more information about the four speakers, registration fees and discounts please visit the website.

The workshop will be hosted by Qserve expert: