CRA vs MDR: Medical-Adjacent Product Compliance
Where CRA stops and MDR/IVDR starts for medical-adjacent products: wellness devices, health apps, telemedicine kit, and products outside the exemption.
Analysis and practical guidance on the EU Cyber Resilience Act. Regulation explainers, SBOM tooling, vulnerability workflows, and ENISA reporting, written for manufacturers, importers, and distributors.
Where CRA stops and MDR/IVDR starts for medical-adjacent products: wellness devices, health apps, telemedicine kit, and products outside the exemption.
How the CRA applies to consumer IoT: default-category duties; Annex III Class I for smart-home security, social/tracking toys and health/children's wearables.
How the CRA applies to industrial automation and OT: IEC 62443 alignment, why most PLCs and SCADA are default-category, and what raises the class.
May 2026: no Notified Bodies under the Cyber Resilience Act, no harmonized standards, no ENISA platform. Article 14 applies 11 September 2026.
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