Duration: 60 Minutes
In February of this year, the EU released the official texts of the new Medical Device Regulation 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.
Why You Should Attend :
At the completion of this webinar, participants will be able to discuss 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. Also to be discussed, will be the strategy that will be employed to transition to the new MDR to ease the burden upon compliance. There will also be a general navigation review of the regulation with a discussion of the contents of each relevant section.
This webinar will detail the changes and discuss their implications upon medical device manufacturers. This is essential for all of those tasked with designing, developing, manufacturing, servicing, and marketing medical devices.
Areas Covered in the Session :
Who Should Attend: