A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU and UK
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.
Upcoming start dates
Suitability - Who should attend?
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
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Reviews by course attendees
Average rating 4.8
Very well run, met my objectives, and speakers were interesting, approachable and very knowledgeable.
A relaxed, open forum where you felt comfortable to ask any questions you needed through the presentations and the day. The speakers were all very clear, concise, factual and in...
About IPI Academy
International Professional & Industry Academy (IPI) is an international leading professional training organisation based in London. Our training solutions provide a return on your investment with measurable results, and are delivered by experienced professionals and managed with exceptional care and...
The speakers were very professional and knowledgeable. They delivered the content in an easy format and allowed plenty of time for questions and interaction from the attendees.
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