DUBLIN, June 7, 2019 /PRNewswire/ -- The "New Medical Device Regulation" conference has been added to ResearchAndMarkets.com's offering.
Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.
The New Medical Device Regulation (MDR) brings about a period of great change, uncertainty and opportunity within the medical technology and diagnostics sectors. This seminar will help you embrace these changes and operate successfully in the new environment in Europe. It will cover in depth the new regulations and their implementation by the Member States and Notified Bodies. You will get to hear the latest thoughts on clinical development, safety monitoring and the implications of Brexit.
Why you should attend
This seminar will provide key guidance and interpretation of the changes to the regulation and will be of value to all those who are involved in placing a medical device on the market, and anyone who requires an essential overview of the new medical device regulation and its impact on the industry and working practices.
Who Should Attend:
Personnel from the following departments:
- Regulatory affairs
- Clinical studies
- Quality systems
- Technical support and business development.
Programme Day One
Introduction and background to the new regulation
- Medical Device Co-ordination Group - Dr David Jefferys
Key preparation for successful implementation
- Where, what, how?
- A road map for the new regulation
- EUDAMED database - maximising the potential
- Implications of Brexit - Oliver Bisazza
Notified Bodies: how the changes will impact NBs and manufacturers - including the new rules for IVD conformity assessment
- Accreditation and designation of NBs
- How to register with NBs
- Conformity assessment applications - Theresa Jeary
Clinical investigations - what is required?
- Greater protection for patients participating in clinical investigations
- Products to have an acceptable benefit to risk ratio
- Product safety and performance
- Changes in data requirements
- Restrictions by individual member states - Janette Benaddi
Programme Day Two
Increased vigilance and post-market surveillance - how to comply
- Post-market surveillance systems appropriate for your device and risk classification
- Periodic Safety Update Reports (PSURs)
- Manufacturers' response times to serious public health threats and deaths caused by devices - Dr David Jefferys
IVDs and companion diagnostics
- Implications and timelines
- New IVD conformity assessment rules
- Theresa Jeary
Other essential considerations
- Authorised representatives - increased responsibilities and requirements
- Single registration numbers for all economic operators
- New categories
- Single-use devices - reprocessing?
- Unique device identification
- Safety and clinical performance summaries
- Strategies to address the new requirements - Dr David Jefferys
Panel discussion and key take-home messages
Senior Vice President
Director of Clinical & Consulting Europe
Technical Manager for Medical Devices
Lloyds Register Quality Assurance (LRQA)
For more information about this conference visit https://www.researchandmarkets.com/r/vp3p2k
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Laura Wood, Senior Manager
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SOURCE Research and Markets