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# CE Marking for Medical Imaging Equipment

Complete guide to CE marking for medical imaging equipment, X-ray systems, and diagnostic devices. Learn about MDR vs general CE requirements for imaging systems.

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## Medical imaging and CE marking

Medical imaging equipment intended for diagnosis or treatment falls under the Medical Device Regulation (MDR), not general CE marking. Non-medical imaging (industrial, security) follows standard CE directives. Distinguish intended use carefully.

## FAQs

### Is medical imaging equipment under MDR or general CE?

Medical imaging equipment intended for diagnosis, monitoring, or treatment falls under MDR (EU) 2017/745. Non-medical imaging (industrial NDT, security scanning) follows general CE marking directives.

### What about X-ray equipment?

X-ray equipment for medical use requires MDR compliance and radiation protection under Council Directive 2013/59/Euratom. This includes strict radiation safety requirements and dose limitation systems.

### Do imaging systems need a Notified Body?

Most medical imaging equipment requires Notified Body involvement under MDR. Classification depends on risk — imaging systems are typically Class IIa, IIb, or III, requiring varying levels of Notified Body assessment.

### What about ultrasound or MRI systems?

Ultrasound and MRI systems for medical diagnosis fall under MDR. They require clinical evaluation, risk management per ISO 14971, and technical documentation demonstrating safety and performance.

### Can I use general CE standards for medical imaging?

No. Medical imaging must comply with MDR-specific requirements including clinical evaluation, post-market surveillance, and vigilance. General CE standards (EMC, LVD) apply but are insufficient for MDR compliance.

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