While regulating the safety of medical devices in the European market is essential, we are concerned about the interpretation of the Medical Device Regulation (MDR) regarding low-risk digital calculators. Despite several borderline manuals published in recent years, the interpretation remains ambiguous and inconsistent. Consequently, classification varies across EU countries notified bodies.
Finnish Institute for Health and Welfare (THL)
Public authority · Finland
Counts here are a floor, never a total: they cover the 687 consultation files tracked so far (60,344 submissions, mostly 2021–26), so an organization's real filing history is larger, not smaller.
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Their record over time
Finnish Institute for Health and Welfare (THL) filed 2 positions between 12 Sept 2025 and 2 Oct 2025, across 2 of the 687 legislative files tracked here.
What they argued
We would like to thank the Commission for bringing forward the burden of cardiovascular diseases (CVDs) and for highlighting that most of these conditions are preventable. The focus on prevention is very welcome and essential in reducing both the health and societal costs caused by CVDs.
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Turns up on the same files
Organizations that also filed on at least two of the same consultations. A shared interest in the same dossiers, not evidence of coordination, and we do not suggest any.
Showing 5 of 43.
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