Update of the borderline guideline on medical devices

Recommendation

15/16 November 2023

Serialization/Aggregation - Live Online Training
Requirements, Challenges & Solutions

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.