Simplifying the Path to Medical Device Regulation (EU MDR)

SIMPLIFYING THE PATH TO MEDICAL DEVICE REGULATION (EU MDR)

Medical Device companies have been given a 12-month reprieve to get their houses in order for EU MDR. By adopting a ‘touch once’ strategy to undergo a comprehensive redesign of global labeling processes, you can simplify your labeling environment at speed.

The drivers for the approach are manifold. Primarily, most organizations are mindful of the ticking clock for EU MDR compliance and the ongoing global climate for regulatory change: if your current labeling infrastructure is dated, you need to find a way to safeguard against future regulations.

The importance of selecting a labeling solution that can adapt to a changing world cannot be overstated. Our data-led labeling solutions support manufacturers to implement compliant EU MDR, as well as to successfully respond to future regulations or technical challenges.

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EU MDR Infographic 10 Sticking points Infographic - Simplifying the Path to Medical Device Regulation (EU MDR) Medical Device Label Before and After EU MDR – 10 Sticking Points Posted in: Achieving Regulatory Compliance, Business Analysis, Infographic Archives, Medical Device, Operations & Labeling, Project Managers, Regulatory & Compliance -

EU MDR introduces additional information that needs to be included on labels, forcing organizations to design new label templates that make room for data not previously part of the labeling system.

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PRISYM ID 10 Steps to EU MDR Labeling Implementation Guide Thumbnail - Simplifying the Path to Medical Device Regulation (EU MDR) 10 Steps to EU MDR Labeling Implementation Posted in: Achieving Regulatory Compliance, Medical Device, Operations & Labeling, Project Managers, Regulatory & Compliance, Whitepaper -

Whether you’re producing medical devices within Europe or supplying to Europe, as a manufacturer or supplier, you will need to adhere to the new EU MDR.

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