CE marking under EU MDR 2017/745 is mandatory for selling medical devices in the EU. The pathway depends on device classification: Class I (self-certification), Class IIa/IIb (notified body audit), Class III (full conformity assessment + clinical investigation). Software with diagnostic function is typically Class IIa.
CE Marking Steps (Class IIa):
- 1. Classify device under MDR Annex VIII
- 2. Appoint Authorized Representative if outside EU
- 3. Establish Quality Management System (ISO 13485)
- 4. Compile Technical Documentation
- 5. Conduct Clinical Evaluation (literature + clinical data)
- 6. Risk Management (ISO 14971)
- 7. Software Lifecycle (IEC 62304)
- 8. Submit to Notified Body for assessment
- 9. Receive CE certificate
- 10. Register in EUDAMED database
Key Takeaways
- CE marking is mandatory for EU medical device sales.
- Software for diagnosis = typically Class IIa under MDR.
- ISO 13485 + ISO 14971 + IEC 62304 = the regulatory trifecta.
- Clinical evaluation is required — plan for it early.
Frequently Asked Questions
AI software for medical diagnosis is typically classified as:▼
Answer: Class IIa (moderate risk)
Under EU MDR, software providing diagnostic support for medical conditions is typically Class IIa. If it directly drives treatment decisions for life-threatening conditions, it could be Class IIb or III.
What standard covers medical device quality management?▼
Answer: ISO 13485
ISO 13485 is the specific quality management standard for medical devices. It builds on ISO 9001 but adds medical device-specific requirements.
Clinical evaluation under MDR requires:▼
Answer: A literature review and/or clinical investigation with patients
Clinical evaluation must demonstrate safety and performance through literature review, clinical investigation, or a combination. The extent depends on device class and novelty.