Article 2(2) of Regulation (EU) 2024/2847 excludes products covered by Regulation (EU) 2017/745 (medical devices) and Regulation (EU) 2017/746 (in vitro diagnostics). If your software is a medical device under the MDR, CRA does not apply. But the boundary is precise: wellness applications, clinical decision support tools not classified as medical devices, hospital management software, and health data analytics platforms do not fall under the MDR — and therefore remain within CRA scope. CRACheck's Product Classifier helps you determine which regime applies and generates the documentation for whichever path is relevant. €149 per product. 15-25 minutes. Browser-side processing only.
€149 one-time · 8-document ZIP · 15–25 minutes · Browser-side
You enter your product data. CRACheck structures the documentation per Article 31 + Annex VII.
The CRA exemption under Article 2(2)(a) applies per product, not per company. If your company manufactures both MDR-classified medical devices and non-MDR health software (wellness apps, clinical workflow tools, analytics dashboards), the medical devices are exempt but the non-MDR products are fully within CRA scope. The exemption follows the product, not the manufacturer.
FDA clearance (510(k), De Novo, PMA) is a US regulatory pathway. It has no bearing on CRA or MDR compliance in the EU. The MDR (Regulation (EU) 2017/745) has its own classification and conformity assessment process. If your product is FDA-cleared but not MDR-classified, the CRA exemption does not apply in the EU. CRA and FDA are independent regulatory systems.
If your product was reclassified from medical device to general wellness under MDR guidance, it loses the Article 2(2)(a) CRA exemption. A product that is no longer a medical device is no longer exempt from CRA. It becomes a product with digital elements under Article 3(1) with full CRA documentation obligations. This reclassification creates a new compliance workstream.
8 PDF documents generated from your data. Each cites the specific article of Regulation (EU) 2024/2847 it complies with.
Critical document for healthtech: determines whether your product falls under MDR (exempt from CRA) or outside MDR (within CRA scope). Documents the classification reasoning.
Art. 31 + Annex VII for non-MDR health software: architecture, health data handling, clinical system integrations, security controls, and conformity assessment path.
Health-specific cybersecurity risk analysis for non-MDR software: patient data confidentiality, clinical workflow integrity, system availability in healthcare environments, and health API security.
Annex II for health software users: data handling disclosure, security properties, update policy, known limitations in clinical contexts, and manufacturer contact.
Art. 28 + Annex V for non-MDR health software. Separate from any MDR declarations for other products.
Vulnerability disclosure policy adapted for health software: escalation paths for vulnerabilities with potential patient safety impact.
ENISA template per Article 14 for health software incidents: compromised health data, clinical workflow disruption, authentication bypass in health platforms. Art. 14(2): early warning within 24h, notification within 72h, final report within 14 days.
Timeline considering both CRA milestones and any MDR transition dates relevant to your product portfolio.
Mira antes de comprar — Descargar dossier de muestra (PDF, empresa ficticia) — Estructura real, artículos reales, formato real. Datos ficticios.
Generated from your data, in your browser. No data leaves your device.
Generates the CRA documentation for non-MDR health software: product classification (including MDR exemption analysis), technical documentation, risk assessment, declaration of conformity, and supporting documents.
Does not classify your product under the MDR (Regulation (EU) 2017/745). Does not produce MDR technical documentation. Does not interact with notified bodies for MDR or CRA. Does not assess clinical safety. Those are medical device regulatory activities handled by your RA/QA team.
CRACheck covers CRA documentation. Your MDR regulatory team covers medical device classification. If the product sits on the boundary, both teams need to coordinate — but the documentation is separate.
Article 64 of Regulation (EU) 2024/2847.
Non-compliance with essential requirements or manufacturer obligations under Article 13.
Missing documentation or conformity assessment.
Misleading information to authorities.
| Criteria | Medical device regulatory consultant | General CRA consultant | Internal RA team | CRACheck |
|---|---|---|---|---|
| Time | 12-24 weeks | 8-16 weeks | 4-8 weeks | 15-25 minutes |
| Cost | €20,000-€40,000 | €10,000-€20,000 | Staff hours | €149 |
| Understands MDR/CRA boundary | Yes | Partially | Depends | Product Classifier |
| Covers CRA documentation if applicable | As add-on scope | Yes | Varies | Yes — 8 documents |
Each non-MDR product needs independent CRA documentation. If your portfolio includes 3 wellness apps, 2 clinical workflow tools, and 1 analytics platform — all outside MDR — each needs its own Article 31 dossier. Volume pricing: 10 products at €99, 30 at €79.
Request Volume PricingCRACheck generates a structured document according to Article 31 and Annex VII of Regulation (EU) 2024/2847 from the information you provide. The accuracy of that information is your responsibility as the manufacturer under Article 13.
We guarantee the document structure follows Article 31 + Annex VII and legal references are correct. We do not guarantee that a product classification determination will be accepted by a market surveillance authority or notified body in a specific case.
CRACheck is not legal advice. For questions about the MDR/CRA boundary or medical device classification, consult a qualified medical device regulatory professional.
Eight documents. Article 31 + Annex VII fully structured. Regulation (EU) 2024/2847. Your data stays on your device. The ZIP you download is yours forever.