new eu medical device regulations - what\'s the impact?

by:Keyuan     2020-06-15
Overview in part due to the Poly Implant Prothese breast augmentation scandal, a French manufacturer replaced the approved medical device
Industrial grade silicone
The European Commission has begun to modify their medical device directives to prevent such problems from happening again, and the breakdown of these silica gel has resulted in a variety of serious medical implants until death.
These changes led to the drafting of a new medical device regulation, which was fully released in February.
The new EMDR is Europe\'s most extensive medical device regulation since 1990s.
Industry experts are concerned that regulations will increase costs and eliminate early equipment innovations currently experienced by European patients.
Understanding the content of the regulation and its implications is essential for the effective design, development, marketing and utilization of medical devices in the EU.
Why should you attend the current medical device regulation, which has 350 pages, is a complex set of regulations written in general law.
Any person who designs, manufactures and/or markets medical devices to the EU needs to be aware of many changes compared to the original Medical Device Directive.
This webinar will detail these changes and discuss their impact and provide more insight into the regulation of medical device manufacturers.
The areas covered by participants at the completion of this webinar will be able to: Explain how the new medical device regulations are a key part of the definition/interpretation of regulations built.
Explain the transition process from the Medical Device Directive to the current medical device regulations. Define key differences between dd and new mrp, including-
Notification agency, clinical evidence, pre-
Market, transparency and traceability, governance and supervision, and describe changes to regulations in Medical Device directives.
Define the process and options for conducting a qualified assessment.
Explain the expanded role of the notified body.
Explain how the new rules will affect American companies.
Learning Objectives The Journal of the Pharmaceutical Era says the new EU medical device regulations are a new landscape for medical devices.
\"The new regulations provide manufacturers and regulators with a broader definition of medical devices and in vitro diagnostic medical devices.
This broader definition will contribute to significant improvements in patient and user safety, device reliability and overall quality of medical device products that will benefit anyone involved in the design, development, marketing and management of medical devices in EU.
Specific positions and functions are diverse and are not limited to any one function or position.
R & D engineer Audit & Compliance personnel/risk management personnel
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