Borderline questions on medical devices
Register now for ECA's GMP Newsletter
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.
Related GMP News
10.09.2025Artificial Intelligence in Medical Devices - the Perspective of Notified Bodies
10.09.2025The small but significant Difference between EN 13485 and EN ISO 13485
10.09.2025Audits of Medical Device Importers
21.01.2025FDA Warning Letter Statistics on Medical Devices in the past Fiscal Year
21.01.2025Artificial Intelligence in Medical Devices - Notified Bodies' Point of View
21.01.2025New FDA Guidance on Risk Analyses for Drugs, Biologics and Combination Products