A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU (European Union) and UK Training Course (Oct 21, 2025) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU (European Union) and UK Training Course (Oct 21, 2025)" training has been added to ResearchAndMarkets.com's offering.

Stay informed on the significant changes since the adoption of the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR), adopted in May 2017.

The landscape of medical device and in-vitro diagnostic regulations in the EU and UK has undergone significant transformation in recent years. With the adoption of the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR) in May 2017, the regulatory framework has become more rigorous and complex. Staying abreast of these changes is crucial for professionals involved in regulatory affairs, quality assurance, and related fields to ensure compliance and maintain market access.

This course is essential for those seeking to stay fully updated on the latest regulatory developments.

Key topics to be addressed:

• Comprehensive insights into the rephrased implementations of MDR and IVDR
• Understand the new guidelines
• Learn about the role and output of the Medical Device Coordination Group (MDCG)
• Recent medical device regulatory developments in the UK, providing a comparative perspective on the evolving regulatory landscape
• Explore potential future developments and the evolving role of the European Medicines Agency (EMA) in the context of medical device regulations

This course offers a unique opportunity to hear from regulatory experts, discuss the implications of current and forthcoming regulations on working practices, and understand the potential impact on future regulatory strategies.

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.

Benefits of attending

• Stay updated on MDR and IVDR implementations, new guidelines, and recent UK regulatory developments
• Explore the changes in the UK regulation as its system becomes independent and moves away from the EU rules
• Navigate the increasingly complex world of device and diagnostic regulations
• Gain insights into future changes to the regulations and how "digital medicine" may be regulated in the future
• Learn from leading regulatory experts and gain practical advice

Certifications:

• CPD: 6 hours for your records
• Certificate of completion

Who Should Attend:

This training course has been designed for all those working or interested in the medical device and diagnostic market in the EU and the UK, including 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

Key Topics Covered:

Overview of the current position with the EU MDR

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

European view from industry - medical devices

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

European view from industry - IVD

• 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 Management Systems (QMS)

Update on the UK MDR proposals for the medical devices including timeline reliance and recognition

Update on the UK MDR proposals including PMS SI 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

Notified Bodies (NBs) & Conformity Assessment Bodies (CABs) - update on progress from an NB perspective

• How many NBs/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

For more information about this training visit https://www.researchandmarkets.com/r/lkro8w

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