Update of the borderline guideline on medical devices
Recommendation
17/18 June 2025
How to ensure GMP compliant Development and LIfe-Cycle-Management for Drug-Device Combination Products
Register now for ECA's GMP Newsletter
At what point is a medical device to be considered a medical device in Europe? The classification of so-called borderline products is sometimes difficult. As we reported before in an article published on 18 October, 2018, an updated EU guideline may be able to help.
The document was updated again in 2018 and now contains 84 pages. The last update clarifies, for example, whether rugby helmets and water filters are to be considered medical devices or not. They are not, and neither are autopsy saws since those are only used on dead bodies.
The updated document can be viewed on the EU's website.
Related GMP News
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
08.10.2024EMA updates Question and Answer Document on Combination Products
08.10.2024Transparency Guidelines for Medical Devices with Artificial Intelligence
12.09.2024Notified Body Survey on Certificates & Applications under the Medical Devices/IVD Regulation