Medical device CE marking

New Manual Borderline and Classification (1.22)

2019-05

The European Commission has updated its manual on borderline and classification.

It includes now:

7. ACCESSORY TO A MEDICAL DEVICE OR AN IN-VITRO DIAGNOSTIC MEDICAL DEVICE
7.6. Automated external defibrillator storage units

8. CLASSIFICATION
8.32 Lubricants intended for alleviation of vaginal dryness

9. SOFTWARE AND MOBILE APPLICATIONS
9.12. Medication decision support software

The manual can be downloaded here: library

Source: http://ec.europa.eu/growth/sectors/medical-devices_en