A Guide On Medical Devices

Summary: Partially because of the Poly Implant Prothese 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 their Medical Device Directives 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 EU MDR Training is the most extensive medical device regulation Europe has 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 medicals devices in the EU. WHY SHOULD YOU ATTEND The current Medical Device Regulation 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 medicals devices into the EU needs to be aware of when compared to the original Medical Device Directives. This webinar will detail the changes and discuss their implications and provide a greater understanding of the regulation medical device manufacturers. AREAS COVERED At the completion of this webinar participant’s will be able to: · Explain how the new Medical Device Regulation is structured· Define/explain the key sections of the regulation.· Explain the transition process from the Medical Device directives to the current Medical Device Regulation· Define the key differences between the MDD and the new MDR to include – notified bodies, clinical evidence, pre-market, transparency and traceability, governance and oversight and descript the changes to regulations from the Medical Device Directives.· Define the process and options for conducting the conformity assessment.· Explain the expanded role of the notified body.· Explain how this new regulation will impact US companies. LEARNING OBJECTIVES Pharma Times Magazine has called the new EU medical device regulation “A new landscape for medical devices.” The new regulation has provided manufacturers and regulators alike with a much broader definition of both medical devices and in vitro diagnostic medical devices. This much broader definition will contribute to a significant improvement of medicals device products in terms of patient and user safety, device reliability, and overall quality If you are looking for FDA Risk Assessment Medical Devices, then check www.mdrconsultants.com/