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.