This guidance aims to clarify how to classify an IVD before placing it on the market. It is also intended to inform regulators and other stakeholders when assessing the class attributed to an IVD by a manufacturer or a health institution.
The classification of a device is defined by its intended purpose, as specified by the manufacturer. It is therefore crucial that the manufacturer clearly indicates the purpose for which the device is intended. This guidance addresses the classification of IVDs and provides clarification rules as set out under Annex VIII of the IVDR by giving some examples and explanations of the IVDR classification rules.
In the revision 2, the following items are changed:
● Rule 1, second indent: minor revision of examples
● Rule 2, class D examples: editorial change
● Rule 3, general comment: editorial change
● Rule 3(f): revised
● Rule 3(j) rationale: editorial change
● Rule 3(m): footnote 8 modified
● Annex 2: added
For further details, please consult the attachment.
MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746