Blog
Practical articles on EU MDR, IEC 62304, ISO 14971 and regulatory compliance — coming soon as a newsletter.
CRA and MedTech: Two Questions Decide Whether You Must Report from 11 September
Two mistakes about the CRA circulate in medtech, and they point in opposite directions. Two questions sort them out: is it a product at all — and does the medical device exemption apply? Why the reporting obligation starts on 11 September 2026, why the installed base is included, and why the reporting channel was still not up in late August.
Read moreFrom MDD to MDR: Why Europe Rewrote the Rules for Medical Devices
For decades the MDD formed the foundation for medical devices in Europe. Since May 2021 it is history. What triggered the change — and what does the MDR actually alter?
Read moreWhat Does the MDR Mean for Start-ups?
Certification costs, waiting times, and Rule 11: the MDR fundamentally changes the start-up calculus in medtech. What founders need to know — and which strategies have proven effective.
Read moreRule 11: Why Your Software Is Probably Class IIa – and What That Means
Rule 11 in Annex VIII of the MDR makes Class IIa the default for decision-supporting software – not the exception. What that means regulatorily and how manufacturers should approach classification correctly.
Read moreStay ahead of the regulations
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