Are You Ready for EU MDR?

September 15, 2016 Minnie Baylor-Henry


Back in 2010 when European regulators announced plans to overhaul legislation on how the European Union oversees medical devices, the industry knew that it would take time for changes to take effect. With the EU reaching agreement on the regulation, it appears that the final Medical Device Regulation (EU MDR) may take effect as early as January 2017. 

I sat down with Jon Lange, a Principal in the Advisory Services practice of EY and its EU MDR lead, to outline how medical devices companies can prepare. Interestingly, during the webinar, only 26 percent of participants said they had completed an assessment of their EU MDR readiness, while 74 percent said EU MDR readiness either wasn’t on their radar or they were waiting until the regulations were final before beginning major prep.

There are two areas in which medical devices companies must prepare for EU MDR—strategy and compliance—and doing the strategic work early will position medical devices companies favorably.

In my conversation with Jon Lange, we outline the following tips:

  • Address strategic issues early. On the day regulations are published, medical devices executives will have so much to do to be compliant that the strategic aspects will fall to the wayside. Laying the business strategy early allows businesses to be in the most competitive position to move forward when regulations are published.
  • Use EU MDR as an opportunity to fundamentally transform your business. Ask questions such as: How can we enhance our brand? How will this shape our portfolio? Will this present M&A opportunities? Should we cull our SKUs?
  • Understand your risk. It’s important to map out the risk across your business, including in R&D, Supply Chain, Regulatory Affairs, Quality Assurance and Commercial. EU MDR will touch each of these areas.
  • Gather the facts. The most important aspect of planning is getting the facts. Once you have a good understanding of your risks and gaps, how the legislation is likely to impact your current product line, and the opportunities EU MDR will present, you can start mapping an EU MDR readiness plan to take to your leadership team.
  • Don’t wait for 100% clarity. The time to act is now.

To listen to the EU Medical Device Regulation webinar, click here. To talk with a YourEncore expert, contact Mary Ellen Schipp ( .


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