2018-10

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

It includes now:

1. MEDICAL DEVICE/IN VITRO DIAGNOSTIC MEDICAL DEVICE
1.25. Mattress covers against mites
1.22. Lubricants intended for body massages and/or sexual intercourse

8. CLASSIFICATION
8.31. Trial hip prosthesis heads or stems

9. SOFTWARE AND MOBILE APPLICATIONS
9.9. Product intended to facilitate conception based on basal body temperature
9.10. Product intended to facilitate conception and enable contraception based on basal body temperature
9.11. Stand-alone software application for conception and contraception purposes using data entered by the patient

The manual can be downloaded here: library

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