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
Course Content
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
