European Commission Publishes Draft Rules In Bid To Reclassify Non-Medical Active Products
The European Commission has launched an initiative to ensure products without a medical purpose that fall under the Medical Device Regulation are appropriately classified by risk, and subject to the same pre- and post-market requirements as comparable medical devices.
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Certain active products without an intended purpose, where member states had concerns over potential inadequate regulation, now fall under stricter Medical Device Regulation rules.
While delays with aspects of the implementation of the Medical Device Regulation are all too familiar, threat of action at European Court of Justice level is unprecedented. But such measures have paid off for manufacturers of non-medical devices.
In the EU, notified bodies are usually designated for a wide spectrum of testing of different types of medical devices under the Medical Device Regulation. The latest organization to be named, however, is a specialist.