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More practical guidance, real-world examples, and less biased or outdated best practices would also help.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.