Tag Archives: IVDR

09Aug/18
EU MDR LSP Tile

Industry Call for EU MDR Freeze

Stop The Clock

MedTech Europe has issued a position paper asking the EU for a “stop the clock mechanism, that freezes the remaining transition time for both regulations until full readiness of the system has been achieved.”  This will create opportunities for Med-Tech companies to take a long view on EU MDR and enable Digital Transformation as a Journey to Support EU MDR and Beyond.

See:  Implementing the New MD and IVD Regulations: Industry Calls for Solutions to Ensure Continuity of Care of Patients. 

EU MDR LSP TileOur Infographic offers you a road map to sustainable, positive disruption.  We’ve also identified some road hazards and areas of interest along the way.

Compliance with Medical Device Regulation 2017/745/EU also commonly referred to as EU MDR, is presenting a significant challenge for the medical device industry.

Executives we’ve talked to have stated:

  • “Older products will present a real challenge for us. 20 and 30 years ago, there weren’t many requirements for human factors, clinical trials and risk data”
  • “We are trying to get our business units to think about the systems as a platform….to execute against business processes which can be shared across organizations”

With the right platform, meeting the next regulatory requirement becomes an issue of formatting the data… not chasing it down.

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