Update for the Borderline Guidance

The EU Commission posted a new version of the Borderline Guidance with revision 1.22


New Amendments in the current version are:

  • Automated external defibrillator storage units
    • If it is intended to be used with an individual AED to store it in the environmental conditions
    • It should be considered an accessory
  • Lubricants intended for alleviation of vaginal dryness
    • According to Rule 5, these lubricants should be classified in class IIa
  • Medication decision support software
    • The software is intended to be used for the purpose of prevention, monitoring, treatment or alleviation of a disease and should therefore be qualified as a medical device.