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Class I Measuring Devices
 
Class I devices with a measuring function must comply with all the requirements for Class I devices. Additionally the manufacturer must:
  • establish and maintain the relevant procedures of a Medical Quality Management System (QMS)

  • contract a Notified Body who will audit the Quality Management System and Technical Files
These requirements shall be limited to the aspects of manufacture concerned with the conformity of the products with the metrological requirements
 
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