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MDR classification
Best MDR classification of a non-invasive, low power (8mW pulsed at 10% duty cycle) near infrared sensor applied to skin (hand web) in a transitory fashion for use over extended periods of time?
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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Kristina Zvonar Brkić
Jun 12, 2023
For the classification rules and help with the classification please see the following guidance:
- MDCG 2021-24 - Guidance on classification of medical devices https://health.ec.europa.eu/latest-updates/mdcg-2021-24-guidance-classification-medical-devices-2021-10-04_en
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Jun 12, 2023
Jun 12, 2023
Jun 12, 2023