The commission has published a new version of the borderline manual

The commission has published a new version of the borderline manual. The most remarkable is the classification decision on a cardiac bypass procedure related cannula, that after decades of discussions are now classified as class III products. And as expected the alcohol absorbers that allow people to drink more alcohol without becoming intoxicated is not seen as medical device. D-mannose for urinary track infection has been ruled to be a pharmaceutical, and that appears in somewhat vague wording also to apply to 8-MOP. Furthermore, Alum styptic pencils have been moved from cosmetics to medical device. Decisions also on radiation shields, microplate washers, breast tissue expanders, dura guard, liquid nitrogen, and mole related software.

Please find here the new version of the borderline manual.

Or visit the website of European Commission.

 

Post date: December 15, 2017
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