The EU Commission just published the latest Version 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.