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What the New Medical Device Regulations (EU MDR) Mean for You

In response to this expanding market, the European Union released new guidance governing medical devices. With the release of Medical Device Regulation (MDR) 2017/745/EU, in 2017, the EU has issued the first updated regulations in more than 20 years. 

In this whitepaper – written in conjunction with the experts at Beanstock Ventures – we cover the new regulations and highlight the most important changes, such as:  

  • Increased scope of medical device definition; 

  • New classification rules (including Rule 11 that specifically addresses software); 

  • Increased scope of general safety and performance requirements, technical documentation, and clinical data and evaluation requirements; 

  •  Introduction of traceability and identification system and database; and 

  • Increased post-market product surveillance. 

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Complying with FDA Design Control Requirements Using RM Principles
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