Dublin, May 30, 2019 (GLOBE NEWSWIRE) -- 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
• Vigilance
• PMS
• Quality systems
• Technical support and business development.

Agenda:

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

Speakers:

David Jefferys
Senior Vice President
Eisai

Janette Benaddi
Director of Clinical & Consulting Europe
NAMSA

Theresa Jeary
Technical Manager for Medical Devices
Lloyds Register Quality Assurance (LRQA)

Oliver Bisazza
Director
MedTech Europe

For more information about this conference visit https://www.researchandmarkets.com/r/d55hmp

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Related Topics: Medical Devices