20/21 March 2024
At what point is a medical device considered a medical device in Europe? So-called borderline products sometimes cause problems regarding classification; a guideline by the European Union may be of help. The document now comprises 82 pages and is updated regularly. The last revision, for example, clarifies whether products for the reduction of alcohol effects are medical devices or not (they are not a medical device) or whether liquid nitrogen for the cryopreservation of human cells for medical application is considered a medical device (yes, class IIa).
The document, like the FDA Guidances for Industry, is not legally binding. It explicitly points out that only the European Court of Justice may interpret European Law. Nevertheless, the guideline is definitely worth reading, especially since it also discusses borderline questions on in vitro diagnostics.
Please also see the MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES for further details.