The EU Commission just published the new Version
(update: in January 2019 a further update was published see News "Version 1.21 of the Borderline and classification Manual published)
of the "Manual Borderline and Classification in the Community Regulatory Framework for Medical Devices."
The Guidance now also includes the following products:
- Mattress covers against mites
- Lubricants intended for body massages and/or sexual intercourse
- Trial hip prosthesis heads or stems
- Product intended to facilitate conception and enable contraception based on basal body temperature
- Stand-alone software application for conception and contraception purposes using data entered by the patient
It is important to notice that this Manual is still only applicable to the 93/42/EEC and NOT to the (EU)2017/745.