New EU Medical Device Regulations and its Implications

Event Information
Product Format
Prerecorded Event
Conference Date
Thu, Mar 30, 2017
60 minutes
Product Description

New European Medical Device Regulations and its Implications upon Manufacturers


Partially as a result of the Poly Implant Prothèse breast implant scandal, the European Commission began developing changes to the MDDs to prevent this type of an issue from happening again. The changes resulted in the drafting of a totally new Medical Device Regulation for the European Union (EU)

Sometime this year, the EU, is expected to vote on the official texts of the new Medical Device Regulation (MDR) 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.

The new EMDR is the most extensive medical device regulation Europe had seen since the 1990’s. Industry experts are concerned that regulations will increase costs and eliminate early access to device innovations that patients in Europe currently experience. Understanding the contents of this regulation and its implications is crucial to the effective design, development, marketing, and utilization of medical devices in the EU.

In this webinar, expert speaker Charles H. Paul will detail the changes and discuss their implications upon medical device manufacturers. Charles will provide strategies that you can employ to transition to the new MDR to ease your compliance burden. He will discuss each relevant section and review the regulations in-depth. After the completion of this webinar, you will be able to comprehend 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.

Session Highlights:

  • 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

Who should attend?

  • All personnel engaged in the classification, design, development, and marketing of medical devices in the EU
  • Audit and Compliance Personnel / Risk Managers
  • Research and Development Engineers
  • Vice-Presidents, Directors, and Managers of medical device design functions
  • Medical device marketing personnel

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Charles H. Paul

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence....   More Info
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