The European Commission has published a key guidance document on the classification of in vitro diagnostic medical device (IVD) under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) to give advice to manufacturers, notified bodies, health organizations and other stakeholders on how to classify an IVD.
The document gives detailed clarification on the seven IVD classification rules, as specified in annex VIII of the IVDR. It provides the underlying principle and examples for demonstrative purposes. It also explains the indents in the rules and includes an annex with illustrative examples.
Manufacturers of IVDs are highly recommended to review the document in detail to get familiar with the logic behind the new IVDR classification system.
Source: Medtech Insight (an Informa product)