🏥 Healthcare Worker Takeaway
This hub gives you instant access to the information you need most on the ward — device classification charts, incident reporting checklists, emergency contacts, and UDI guidance. Bookmark this page, download the pocket reference cards, and keep them handy. When something goes wrong with a device, speed and accuracy matter.
MDR Device Classes (Regulation 2017/745)
🟢
Class I(Low risk)
Bandages, stethoscopes, hospital beds, tongue depressors, wheelchairs
NB: No (self-certification)
🟡
Class IIa(Medium risk)
Syringes, dental fillings, hearing aids, surgical gloves, blood pressure monitors
NB: Yes
🟠
Class IIb(Higher risk)
Ventilators, infusion pumps, dialysis machines, X-ray equipment, surgical lasers
NB: Yes
🔴
Class III(Highest risk)
Heart valves, hip implants, pacemakers, breast implants, drug-eluting stents
NB: Yes (strictest)
NB = Notified Body involvement required for conformity assessment
IVDR Device Classes (Regulation 2017/746)
🟢
Class A(Low risk)
Lab instruments, specimen containers, wash buffers, culture media
🔵
Class B(Moderate risk)
Pregnancy tests, cholesterol tests, urine test strips, clinical chemistry analysers
🟠
Class C(High risk)
Glucose meters, companion diagnostics, genetic tests, cancer markers
🔴
Class D(Highest risk)
HIV tests, hepatitis B/C tests, blood typing (ABO/Rh), transfusion screening
Key Takeaways
- Classification determines regulatory burden — higher class = more requirements, NB involvement, and clinical evidence
- Incident reporting starts with patient safety, then preserve evidence, document everything, and escalate promptly
- The HPRA is your Competent Authority — report serious incidents and check for field safety notices regularly
- UDI enables traceability from manufacturer to patient — learn to read it on every device you handle
- Download and print the pocket reference cards — keep them at the nurses' station or in your clinical engineering office
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