European borderline classification issues

Another version (1.1, May 2008) of the Manual on Borderline and Classification in the EU Community has been published.

Manual on Borderline and Classification in the Community
Regulatory Framework for Medical Devices, Version 1.1 (May 2008)

Version 1.1 adds approximately ten new examples. While this is guidance and many of the products may not be relevant, they do provide examples and capture the opinions of various regulatory officials.

One example of note is the classification of different types of Picture Archiving and Communication Systems (PACS).

  • PACS for only archiving or storage may not be a medical devices
  • PACS for viewing, archiving, and transmitting images may be Class I (Rule 12) medical device.
  • PACS for post-processing of the image for diagnostic purposes (post processing which alters image data: filtering, multiplanar reconstruction, 3D reconstruction) likely Class IIa (Rule 10) medical device.
  • PACS which drives or influences source same class as source device (Implementing Rule 2.3).
  • PACS with image enhancement or control image acquisition same class as source device Class IIa or Class IIb (Rule 10).

Other examples:

  • Single or multiple channel pipettes
  • In-Vitro Fertilization (IVF) and Assisted Reproductive Technologies (ART) products
  • Hand disinfectants
  • Surgical instrument decontamination products
  • Dental water line disinfectants
  • Blood refrigerators, freezers and defrosters
  • Warming blankets
  • Products evaluating the condition of respiratory muscles
  • Neutral electrodes for high frequency surgery

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