Tag Archive for: Europe

MDR - Medical Device RegulationsIn this post, we pull out key takeaways from a recent whitepaper written in conjunction with Beanstock Ventures on the new EU medical device regulations (EU MDR) and how they might impact medical device development. 

As medical device technologies have rapidly advanced in recent years, regulations governing definitions, testing, and post-market activities have struggled to keep up. The pace of change and adoption of these technologies has made it difficult for governments and agencies to create the kind of inclusive and expansive rules that will ensure safety.

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. The new Medical Device Regulation (MDR) 2017/745/EU addresses software as a medical device [SaMD], as well as other products. It also places stringent requirements for compliance with post-market activities and post-market surveillance. While enforcement of these new regulations was scheduled to begin in May 2020, it was postponed until May 2021 due to the COVID-19 pandemic. What do these new regulations mean for the medical device industry? Experts from Beanstock Ventures explain what you need to know for EU MDR compliance.

RELATED POST: Ensuring FDA Compliance for Your Digital Health Solution

Key Takeaways:

  • The EU Medical Devices Regulation (MDR) has replaced the EU Medical Device Directive effective 26 May 2021.
  • The EU MDR is greatly expanded to cover more devices, including Software as Medical Device, implantable devices, contact lenses, and many digital health technologies. It also promotes a lifecycle approach to regulation.
  • EU MDR requires improved device traceability by introduction of a unique identification system, or UDI (see section 05), for medical devices approved for use in the EU. To keep track of devices through every lifecycle stage, a device identifier (UDI) will be assigned, and all production series will be marked with a production identifier.

EU Medical Devices Regulation (MDR), adopted by the European Parliament and Council as REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017, has replaced the former EU Medical Device Directive (MDD) and went into effect 26 May 2021. After this date, the MDR is applicable for all medical devices sold (developed or imported) in the European Union.

The most important changes in the EU MDR include:

  • 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.

To learn more about EU MDR, download the full whitepaper

Today’s announcement of our European headquarters in Amsterdam, The Netherlands, marks a milestone for Jama Software and our customers around the globe. Since our early days, Jama Software has served a global customer base. Opening this new headquarters further reflects our commitment to serving innovators around the world, and increasing the level of local support and service to a growing number of customers developing new products in Europe.

In recent years, we grew our support capabilities, adding Europe-based, multi-lingual team members to better meet our customers’ needs. Spearheading this next step is Jama Software’s co-founder Eric Winquist, who will oversee our European efforts from The Netherlands. Eric has worked with many of our European customers over the years and I’m glad they’ll be in his capable hands.

Additionally, our fiscal year 2017 closed on April 30, and it was one of exponential growth for Jama Software. More than 100 new companies globally started using our product development platform and more than 250 existing customers expanded use of Jama Software to new teams and divisions. That growth has helped fuel our overseas expansion.

As we charge into our new fiscal year, we’re focused on modernizing, digitizing, and transforming complex product development for our customers. We’re inspired by the amazing technology customers like Ekso Bionics, Spaceflight Industries, Zoll LifeVest, and NASA are developing. The year ahead holds lots of exciting things for Jama Software and we look forward to continuing this journey with the Jama Nation.