The European Commission provided further guidance for devicemakers on how to distinguish borderline devices and in vitro diagnostics in a new Version 1.19 of its manual on borderline and classification for medical devices.
The manual notes that borderline cases can occur when it is unclear whether a product is a device, an in vitro diagnostic, an active implantable or not, so it is difficult to apply the classification rules of the Medical Devices Directive.
Different interpretations can occur among EU member states, the Commission said, noting the manual is a result of discussions of borderline and classification meetings among regulators to provide feedback on products that have raised doubts or concerns.
The manual includes recent decisions on whether certain products claimed by the manufacturer to be medical devices or IVDs actually qualify as medical devices or IVDs under the new regulations.
For example, a light box indicated to treat seasonal affective disorder (SAD) was deemed to be a medical device. However, the equipment used for pharmacy compounding was deemed not to be a medical device.
Similarly, a thermomixer intended to control the temperature of and to mix liquids for preparing and processing samples for IVD applications, were not considered IVDs or medical devices.
In recent decisions, rugby helmets, autopsy saws, UV flow germicidal lamps, water filters, bone void fillers containing animal growth factors, weight management products were deemed not to be medical devices, while whole body and partial body cryotherapy chambers qualified as medical devices.
The manual provides guidance on whether certain borderline IVDs would in fact qualify as IVDs under the IVD Directive, including decisions for CE-labeled microscope slides, channel pipettes and fluid collection bowls.
Certain solutions or medicines can be considered medical devices when they are used for the purpose of diagnosis or to control conception, so in-vitro fertilization and assisted reproductive technology products qualify as medical devices. However, peritoneal dialysis solutions do not qualify as medical devices.
Agents for transporting and storing organs intended for transplant are considered medical devices and creams containing zinc oxide qualify as medical devices but hand disinfectants do not.
Devicemakers can review the new manual to get a sense of the European regulators’ current thinking and how they may deal with other borderline cases.
Read the EC manual here: www.fdanews.com/05-22-18-ECmanual.pdf.