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

Question

I am interested in understanding how medical device regulation, specifically the MDR, is developed and what could be done to improve its usability, especially for small start-ups. From my experience as a QA/RA professional, I find that the MDR and related standards are difficult to read, assume prior knowledge, and require additional guidance. This can be especially challenging for smaller companies without extensive regulatory resources.
Some specific questions:
• How are regulations like the MDR created and who is involved in the process?
• What opportunities exist for individuals or companies to contribute to making regulations or standards more usable?
• What would be needed to increase the usability of these regulations, particularly for start-ups?

Dr. Oliver Eidel · Accepted Answer

Regulation like the MDR is developed at the EU level as part of the "new legislative framework" for product safety. The process involves EU institutions, national authorities, and input from industry experts, though direct participation for individuals is limited. The MDR is law, whereas ISO standards are voluntary but often referenced to demonstrate compliance.
To make regulations more usable, especially for start-ups, joining national standards committees (normcommissies) can be a good way to have an impact. These groups sometimes propose new standards or updates that are later adopted internationally. While direct involvement in drafting the MDR isn't possible for most, you can influence standards and guidance documents by participating in these working groups.
More practical guidance, real-world examples, and less biased or outdated best practices would also help. The MDR is intentionally broad to cover many devices, but this can make it hard to navigate. Supplementing official documents with high-quality, up-to-date resources—ideally from a range of experienced voices—can help bridge the gap. As more guidance and examples become available, the process should become more accessible.

Answer

Regulatory science has some influence on the development of standards and regulations, as it brings in scientific verification and validation principles. However, there can be a lag when it comes to new technologies, especially software or AI, as existing standards often focus on physical products. This gap makes it harder for innovators in digital health to rely on current guidance, so pushing for updated standards through participation in working groups is important.

Answer

From my experience implementing standards at a small company, it's much easier to find resources for some regulations (like ISO 27001) compared to others like ISO 13485. The lack of freely available, practical guidance for medical device standards is a big barrier for start-ups. More open resources and affordable expert advice would go a long way toward making compliance more achievable.

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

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