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
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- 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
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- According to Rule 5, these lubricants should be classified in class IIa
- Medication decision support software
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- 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.