The European Commission has clarified in its newly updated manual on borderline products that software and mobile apps that use basal body temperature (BBT) to facilitate conception or enable contraception are medical devices. It has also explained how to classify these products.
The inclusion of this product category in version 1.20 of the manual follows recent controversy over the CE-marked smartphone-based contraceptive Natural Cycle, which was advertised as being “highly accurate”...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?