Regulation
Medical Device Regulation (Reg (EU) 2017/745)
article-level, incl. annexes
Sector · Healthcare
Healthcare & medical devices
Medical-device regulation and health-data privacy, grounded article by article.
Ansvar is a gateway for the AI assistant your team already uses — Claude, Microsoft Copilot, any MCP client. Connect it, and every answer below comes back cited to the provision or marked unresolved.
MDR · IVDRarticle-level + annexes
Art. 9special-category health data
Freethe EU regulations, every tier
MDR, IVDR, the Clinical Trials Regulation and the European Health Data Space are served at article level, alongside GDPR Article 9 for special-category health data and the horizontal cyber regimes. Ask the provision; then run the DPIA, gap analysis or device threat model that turns it into evidence.
what we cover
The law and standards we ground on
Regulation
In Vitro Diagnostic Regulation (Reg (EU) 2017/746)
Regulation
Clinical Trials Regulation (Reg (EU) 536/2014)
Regulation
European Health Data Space (Reg (EU) 2025/327)
Regulation
GDPR Art. 9 — special-category health data (+ full GDPR)
Regulation
Horizontal: NIS2 · EU AI Act (software as a medical device) · CRA
GuidancePremium
MDCG medical-device guidance
what you can do
Workflows that turn it into evidence
DPIA for special-category health data
GDPR Art. 35 + Art. 9, with Germany and Sweden variants
Regulatory gap analysis
against MDR / IVDR / GDPR / NIS2, with a dedicated NIS2 variant
Medical-device product-security threat model
STRIDE over a device data-flow diagram — not a device-conformity verdict
LINDDUN privacy threat model
for clinical and patient-data flows
FRIA — EU AI Act Art. 27
for AI-based devices and high-risk software-as-a-medical-device AI
Document review, paragraph-cited
technical documentation, clinical SOPs and QMS documents
STRIDE threat-model workflows run on every plan against a system you describe — 1 run a month on Free, 2 on Solo, 5 on Premium, which also adds the LINDDUN and TARA families, the rendered reports, and case law inside the run. Document-grounded workflows run on Team and Company. Every tier runs the same corpora as cited research inside your own AI client.
Questions buyers ask first
- Does this certify a device as conforming?
- No. The workflows produce a cited gap analysis and a STRIDE threat model against MDR/IVDR and the security obligations — decision-support, not a conformity verdict or a notified-body assessment.
- Is national health law covered?
- The EU regulations (MDR, IVDR, CTR, EHDS) and GDPR are covered at article level. Beyond the EU layer, Ansvar serves dedicated national medical-device regulation corpora for jurisdictions across Europe, the Americas and Asia-Pacific — see the coverage page for the live list — and national health statutes are also reachable inside the audited national-law corpora.
Run it against your own systems
Connect the AI client you already use and ask your first cited question — Free, Solo, Premium and Team are self-serve.
Building healthcare compliance? It works today — we take on a few design partners per sector to tune it to your team.