CE Marking for Medical Devices Made Simple

CE marking for medical devices requires conformity assessment against the EU Medical Device Regulation (MDR), preparation of a comprehensive technical file, a clinical evaluation, a risk management report aligned with harmonized standards, and review by a notified body for higher-risk device classes. Hardware Compliance's AI agents research every applicable requirement for your specific device, auto-generate the required documentation, and connect you with the right accredited testing lab to support the process.

Traditional regulatory affairs consultants charge by the hour and can take months to deliver the documentation a CE marking submission requires. Hardware Compliance's AI agents perform the same regulatory research and documentation drafting in a fraction of the time, and every output is reviewed and signed off by industry professionals before submission. You get the speed of AI with the accountability of expert review, at a lower overall cost than traditional consulting.

Hardware Compliance covers CE marking alongside a broad set of harmonized and product-specific standards relevant to medical devices. The platform's AI agents read and reason across thousands of pages of regulatory standards to surface every requirement applicable to your device. Beyond CE, Hardware Compliance also covers FDA 510(k), ISO, IEC, and other standards if you are pursuing multi-market clearance simultaneously.

Hardware Compliance replaces months of compliance consulting with an AI-agent-driven workflow that operates in weeks. The actual certification timeline depends on your device class, the notified body's review schedule, and any testing required — factors outside any platform's control. What Hardware Compliance compresses is the research, documentation assembly, and lab coordination phases that typically consume the most time before formal review even begins.

Hardware Compliance supports multi-market compliance, mapping requirements across the EU, US, UK, and other jurisdictions simultaneously. If your medical device needs both CE marking and FDA 510(k) clearance, Hardware Compliance's AI agents can research and surface requirements for both in parallel, and the compliance dashboard tracks every requirement, document, and status update across all target markets in one place.