EC Classifies Four Borderline Medical Devices

The European Commission (EC) has classified several “borderline” medical devices, including eye drops, in its most recent revision to the Manual on Borderline and Classification in the Community. The manual represents the EC’s views on particular products or product categories that have raised doubts about whether they should be classified as medical devices, in vitro diagnostics, implantable devices or non-devices. The updated manual clarifies that eye drops are regulated as medical devices, and drops intended for disinfecting, cleaning, rinsing or hydrating contact lenses are considered Class IIb.
International Medical Device Regulatory Monitor