Background

Under the EU IVDR, Annex VIII, IVDs are classified based on 7 different rules, each of which assigns a classification based on risk levels. Class A non-sterile, which may be “self-certified” by the manufacturer, is the lowest. And then classification progressively grows higher, to Class A sterile, Class B, Class C, and Class D, all of which require Notified Body certification.

MDCG 2020-16 ‘Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746’ provides guidance on how to properly classify IVD devices under the Annex VIII rules. It provides:

• Definitions for terms such as “newborn”, “instrument”, “life-threatening”, and more
• Line by line guidance against each classification rule
• Examples of IVD devices that fall within each classification rule

The Update

MDCG 2020-16 rev.5 is available: HERE

It was updated to provide clarification of the rationale, and revision examples, under IVDR Annex VIII Rule 7, which notes that ‘Devices which are controls without a quantitative or qualitative assigned value are classified as class B’.

Below we have shared an image of the differences between Rev.4 and the new Rev.5.