Dublin, Jan. 20, 2020 (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.

Course Overview

During a period of great uncertainty and opportunity within the medical technology and diagnostics sectors, this seminar will help you prepare for these changes and operate successfully in Europe.

The programme will provide in-depth coverage of the new regulations and how they will be implemented by member states and Notified Bodies. You will hear the latest thoughts on clinical development, safety monitoring, the role of authorised representatives, economic operators, and the implications of Brexit.

There will be plenty of opportunities to discuss the implications of the changes with our expert faculty, and you will gain valuable guidance on successful implementation of the regulatory changes for your company products.

This is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

Why You Should Attend

The seminar will provide key guidance and interpretation of the changes to the regulations and will be of value to all those who are involved with placing a medical device on the market, and anyone who requires an essential overview of the new MDR and its impact on the industry and working practices.

Agenda

Programme Day One

Chair's welcome and Introduction
Dr David Jefferys

Introduction and background to the new regulation

• Medical Device Coordination Groups

Dr David Jefferys

Discussion session

Successful implementation of the MDR

• Managing the urgency - time and resources are tight
• What you really need to know - how to meet the key requirements
• Clinical evidence - don't underestimate its importance
• The B word (Brexit)

Peter Rose

Discussion session

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

Discussion session

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

Discussion session

Programme Day Two

IVDs and companion diagnostics

• Implications and timelines
• New IVD conformity assessment rules
  Theresa Jeary

Discussion session

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

Discussion session

Other essential considerations

• Authorised representatives - increased responsibilities and requirements
• Single registration numbers for all economic operators
• New categories
• Single-use devices - reprocessing?
  Dr David Jefferys

Discussion session

Other essential considerations (continued)

• Unique device identification
• Safety and clinical performance summaries
• Strategies to address the new requirements
  Dr David Jefferys

Discussion session and key take-home messages

For more information about this conference visit https://www.researchandmarkets.com/r/b6xata

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