Reclassification Of Active Annex XVI Products Now Official

Certain active products without an intended purpose, where member states had concerns over potential inadequate regulation, now fall under stricter Medical Device Regulation rules.

Cyber brain (Carlos Amarillo/Shutterstock.com)
Devices For Brain Stimulation Among Those Upclassified

The European Commission has published an Implementing Regulation laying down rules for the reclassification of groups of certain active products without an intended medical purpose which fall under Annex XVI of the Medical Device Regulation.

The new risk classification rules for active devices without an intended purpose will apply from 21 December, are directly applicable in all member states, and are as follows:

What Is Annex XVI?

The regulation of products with no intended medical purpose and which are generally, but not exclusively, used for aesthetic...

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