SVDGV Statement: Ensuring Legal Certainty and Proportionality in the Classification of Software and AI-Based Medical Devices (MDR Reform, Annex VIII, Rule 11) The German Digital Healthcare Association (SVDGV) welcomes the Commission's proposal (COM(2025) 1023 final) to simplify the MDR and align software risk classification with actual patient risk. We raise two concerns: 1.
Spitzenverband Digitale Gesundheitsversorgung e.V.
Industry association · Germany · EU Transparency Register 041077193145-51
Counts here are a floor, never a total: they cover the 326 consultation files tracked so far (29,503 submissions, mostly 2025–26), so an organization's real filing history is larger, not smaller.
Who they are
Among the 784 non-governmental organisations on this site, they rank #734 by legislative files engaged — a count of participation, not a measure of influence.
Declares membership of
- Deutsche Gesellschaft für Innere Medizin e.V.
- DIN Deutsches Institut für Normung e. V.
- Beirat gematik
Self-declared to the EU Transparency Register (snapshot 30 Aug 2026).
- Register category
- Non-governmental organisations
- Head office
- Berlin, Germany
Self-declared to the EU Transparency Register (snapshot 30 Aug 2026); cost bands are floors, not audited totals. Reused under Commission Decision 2011/833/EU.
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Their record over time
Spitzenverband Digitale Gesundheitsversorgung e.V. filed 1 position on 3 Aug 2026, across 1 of the 326 legislative files tracked here, attaching a full position paper 1 time.
What they argued
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Everything on this page comes from Spitzenverband Digitale Gesundheitsversorgung e.V.’s own submissions to the European Commission — we have added nothing and interpreted nothing. If something is wrong or out of date, email info@policyspeak.com and we will correct it. If you are an individual named in a record, our privacy policy sets out your rights to correction, objection and removal.
Quotes are verbatim from submissions published by the European Commission, trimmed to their opening passage and never summarized by a model. Organizations only, never individuals. Reused under Commission Decision 2011/833/EU; the European Commission is not liable for this reuse.