YourEncore Insights - Life Sciences

[Recording] EU Medical Device Regulation Presentation

Posted by Tim Franson, MD on 5/4/16 8:30 AM

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How has your company been preparing for EU MDR?

Minnie Baylor-Henry and Jon Lange discussed this topic during one of our most well attended webinars last month. If you missed the live event, you can now watch the recorded presentation below.

 

This presentation by leaders from YourEncore and Ernst & Young included in-depth content and insights. One section of the presentation included a list of basic questions to start assessing risk:

  • What proportion of our portfolio’s are implicated by the restrictive substance changes?
  • Will we have extensive Clinical Investigations to be conducted for our high risk devices?
  • How does UDI under MDR/IVDR differ from the US UDI solution?
  • How does language specific labelling impact packaging design ?
  • Will the current ‘artwork’ process be capable of handling the MDR/IVDR labelling complexity?
  • Can current processes handle the anticipated volume of complaints and questions  from the authorities?
  • What level of change do we have in our technical files?
  • How many of our products have up to date PMS plans?
  • How will our re-certification plans be impacted in the transition period?
  • Do we need to align with our NB’s on how the new MDR/IVDR will be assessed?
  • Is our QMS up-to-date and able to deal with all the changes?
  • Which companies will revise their business model?
  • What new market strategies will be developed by competitors?
  • Which companies will withdraw products from the market?
  • To what extent is incremental innovation still adding business value when compliance costs increase? Is a more radical approach more profitable?

Don't miss out! Click here to view the last webinar session. 

 

Topics: Med Dev, FDA