DUBLIN--(BUSINESS WIRE)--The "6-Hour Virtual Seminar - The New EU Medical Device Regulation" webinar has been added to ResearchAndMarkets.com's offering.
In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices.
In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject.
The revisions therefore affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.
This seminar will look at what to expect when the new regulation is implemented. Including: the transition period, Effect on Notified Bodies, Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.
Who Should Attend?
- Clinical Trial Managers
- Regulatory Affairs
- Medical Officers
1. The Updated Regulation
2. Implementation Dates & Transition
3. Main Changes & Products Affected
4. Effect on Medical Device Manufacturers
For more information about this webinar visit https://www.researchandmarkets.com/r/6cne5c