MDCG guidance on classification rules for IVDs revised
15 March 2023
The Medical Device Coordination Group (MDCG) updated the MDCG document “Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746″ (MDCG 2020-16 Rev. 2) on February 10, 2023. The second revision of MDCG 2020-16 also takes into account the Corrigendum published in the Official Journal of the European Union on December 27, 2019.
The guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII. This classification guidance also applies to diagnostic or information society services performed on EU patients or devices put into service through distance sales.
The primary purpose of MDCG 2020-16 Rev. 2 is to provide guidance to manufacturers, notified bodies and health institutions on how to classify an IVD prior to placing it on the market, making available on the market or putting into service in the Union. 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.
MDCG has made changes to the following sections of the guidance in this revision:
- Rule 1 – second indent (minor revisions 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)
Revision 1 of MDCG 2020-16 amended Rule 5(b) (examples revised).