The new Medical Devices Regulation (MDR)

On April 5., 2017, the EU Parliament adopted the new Medical Devices Regulation (MDR). The scheme entered into force on May 25., 2017. 

Due to lower personnel capacities and funding opportunities, small SMEs could be particularly hit hard by the demanding new clinical requirements as well as the comprehensive documentation and reporting obligations.

 

Under the new rules, medtech companies will have to:

  • Provide substantially more clinical evidence to get products to market, or even to keep some products on the market
  • Conduct deep portfolio audits to determine the new rules’ impact on margins
  • Relabel products and make data ready to be made publicly available

We  will support our clients in this transition by:

  

    • providing guidance to quality and risk related questions
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    • supporting transition planning (MDD -> MDR)
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    • helping with strategy planning and finance consulting
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    • supporting due diligence activities and M&A activities
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    • providing guidance to clinical trial planning and clinical evaluation reporting