European Commission Publishes Updated Borderline & Classification Manual

On October 30, 2018 the European Commission published a new version of the Borderline & Classification Manual. This manual is intended to provide guidance on the status of medical devices and in vitro diagnostics and their risk classifications.

The manual adds six new items: two to help determine medical intended purpose, one for classification and three about mobile software.

Borderline ? medical intended purpose

1. Mattress covers against mites (not considered a medical device); 

2. Lubricants intended for body massages and/or to help sexual intercourse; (lubricants for body massages or that are intended only to stimulate sexual intercourse are not considered medical devices; lubricants for vaginal dryness or specifically intended to be used with a condom should be considered medical devices).

Classification

Trial hip prosthesis heads or stems (considered to be Class IIa).

Software and mobile applications

1. Product intended to facilitate conception based on basal body temperature (considered active medical device under Rule 12 – Class I);

2. Product intended to facilitate conception and enable contraception based on basal body temperature (considered active medical device under Rule 14 – Class IIb);

3. Stand-alone software application for conception and contraception purposes using data entered by the patient (considered active medical device under Rule 14 – Class IIb).

The Manual has been added to our CE Marking Library in the platform.