The official texts of the new Medical Device Regulation and the new InVitro Diagnostic Regulation have been released. 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 need to be aware of when compared to the original Medical Device Directives. This webinar will detail the changes and discuss their implications upon medical device manufacturers.
Partially as a result of the Poly Implant Prothèse breast implant scandal, where a French manufacturer substituted approved medical-grade silicone with industrial-grade silicone that ruptured causing a variety of serious medical implants up to and including death, 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 that was fully released this past February.
The new EMDR is the most extensive medical device regulation Europe has seen since the 1990s. 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.
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. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems.