New EU Medical Device Regulation – Everything That You Need To Know

In February of this year, the EU released the official texts of the new Medical Device Regulation and the new InVitro Diagnostic Regulation. The current MDR stands at 350 pages and is a complex array of regulations written in the normal legalese. There are many changes that anyone designing, manufacturing, and/or marketing medical devices into the EU needs to be aware of when compared to the original Medical Device Directives.

Why You Should Attend :

At the completion of this webinar, participants will be able to discuss the changes to the MDR as compared to the current Medical Device Directives in terms of notified bodies, clinical evidence, pre-market, transparency and traceability, and governance and oversight. Also to be discussed, will be the strategy that will be employed to transition to the new MDR to ease the burden upon compliance. There will also be a general navigation review of the regulation with a discussion of the contents of each relevant section.

This webinar will detail the changes and discuss their implications upon medical device manufacturers. This is essential for all of those tasked with designing, developing, manufacturing, servicing, and marketing medical devices.

Areas Covered in the Session : 

• Current state of the MDDs and MDR
• Transition period
• Key changes – notified bodies, clinical evidence, pre-market, transparency and traceability, governance and oversight
• Regulation overview
• Changes to rules
• Conformity assessment procedures
• Notified body designation
• How this new regulation will impact US companies
• Interactive Q&A Session

Who Should Attend:

• Quality Departments
• Regulatory Departments
• Compliance Departments
• Research and Development Departments
• Audit Personnel
• Risk Managers
• Engineering Departments
• Vice-Presidents, Directors, and Managers of Medical Device Design Functions
• Medical Device Marketing Personnel
• Members of American Society for Quality
• Members of Medical Device Manufacturers Association
• Members of European Medical Device Technology
• Members of Gulf Coast Medical Device Manufacturers

Course Director: CHARLES H. PAUL

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.