New Medical Device Regulation

This In-house course manages the transition to the new regulation.

Course Overview

This is a period of great change, uncertainty and opportunity within the medical technology and diagnostics sectors. This seminar will help you prepare for these changes and operate successfully in the changed environment in Europe. The seminar will cover in depth 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 and the implications of Brexit.

This is an In-house course you can’t afford to miss as you put in place your strategies for the new environment.

What Team Would Benefit

Personnel from the following departments:

  • Regulatory affairs
  • Clinical studies
  • Vigilance
  • PMS
  • Quality systems
  • Technical support and business development.

Why Your Team Should Do The Course

This In-house course will provide key guidance and interpretation of the changes to the regulation 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 medical device regulation and its impact on the industry and working practices.

Sample Programme Day 1

09.30 Chairman’s welcome and introduction
Dr David Jefferys

09.45 Introduction and background to the new regulation
  • Medical Device Co-ordination Groups
    Dr David Jefferys

10.45 Discussion

11.00 Refreshments

11.30 Key Preparation for successful implementation
  • Where, what, how?
  • A road map for the new regulation
  • EUDAMED database – maximizing the potential
  • Implications of Brexit
    John Wilkinson

12.30 Discussion

12.45 Lunch

13.45 Notified Bodies: How the changes will impact NBs and manufacturer’s – including the new rules for IVD conformity assessment
  • Accreditation and designation of NBs
  • How to register with NBs
  • Conformity assessment applications
    Theresa Jeary

15.00 Discussion

15.10 Refreshments

15.30 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)
  • Manufacturer’s response times to serious public health threats and deaths caused by devices
    Dr David Jefferys

16.45 Discussion

17.00 Close of day one

Sample Programme Day 2

09.00 Welcome to day two
Dr David Jefferys

09.30 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

10.30 Discussion

10.45 Refreshments

11.15 IVDs and companion diagnostics
  • Implications and timelines
  • New IVD conformity assessment rules
    Theresa Jeary

12.30 Discussion

12.45 Lunch

13.45 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

14.45 Discussion

14.50 Refreshments

15.15 Other essential considerations (continued)
  • Unique device identification
  • Safety and clinical performance summaries
  • Strategies to address the new requirements
    Dr David Jefferys

16.15 Panel discussion and key take home messages

16.30 Close of forum

Bespoke training

We can customise this course to meet the requirements of your organisation. Contact us to discuss your training requirements.

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