How can the usability of the MDR and related standards be improved for startups?

Question

One user described difficulties in applying the Medical Device Regulation (MDR) and related standards, especially as a startup. The user finds the regulations and standards difficult to read and understand, requiring additional guidance and assuming prior knowledge of industry best practices. They note that many tools required by these regulations do not add value in their context, and the lack of accessible QA/RA professionals raises costs. The user seeks to understand how regulation is made, what would be needed to increase usability (particularly for startups), and how someone early in their career could contribute to improving usability of medical device regulations.

Dr. Oliver Eidel · Accepted Answer

Great question! I think improving the usability of the MDR and related standards is a big challenge, especially for startups. The MDR is law and ISO standards are technically voluntary, but both are complex and can feel overwhelming. Here are a few key points:• The MDR is based on the EU's "new legislative framework" for CE marking across multiple product types. This harmonises requirements, but also makes the regulation broad and sometimes hard to follow for specific cases like digital health or startups.
• Guidance documents, such as those from the MDCG, are meant to clarify the requirements, but their quality and usefulness can vary. More guidance doesn't always mean better guidance—it can add to the confusion if not well written or kept up to date.
• ISO standards are developed by international working groups, and it's possible (through national committees) for industry professionals to participate and influence them. This is one way someone early in their career could help make regulations more usable—by joining a national standards committee.
• For startups, having more practical, example-driven resources (like open Q&A, best practice guides, or case studies) would really help. The EU could do more to provide these kinds of resources directly.
• Ultimately, regulation usability is improved when there's a feedback loop between those who must comply (like startups) and those who create the rules and guidance.

TL;DR: Consider joining a standards committee to help shape future guidance, and look for practical resources where possible. The system improves as more people with hands-on experience get involved in the process.

Answer

In my experience, the main difference between implementing standards like ISO 13485 and ISO 27001 is the availability of practical resources and the cost of consultants. There is way more freely available information online for ISO 27001 than for ISO 13485, which makes a big difference in understanding and applying the standards. For MDR, having more accessible and practical resources would definitely help startups.

Answer

I agree that the lack of practical examples and resources makes it harder to apply the MDR, especially for newcomers. Other industries sometimes have more practical guides or walkthroughs, which help people learn by doing. Maybe the EU could invest more in creating these kinds of resources for medical devices.

Answer

Regulatory science plays a role in developing and updating standards, often based on scientific evidence and consensus from international working groups. While it doesn't always keep up with new technologies, participating in these groups or following their developments can help bridge knowledge gaps and improve standard usability over time.

How can the usability of the MDR and related standards be improved for startups?

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How can the usability of the MDR and related standards be improved for startups?

4 Answers

Keep reading

How is medical device regulation developed and how can its usability be improved for start-ups?

Do We Have to Read Those Boring Standards?

July 2023 Updates: New Usability Articles, MDCG Q&amp;A On Transition, Open Source QMS Software

July 2023 Updates: New Usability Articles, MDCG Q&A On Transition, Open Source QMS Software