Update of MDCG 2020-16 Guidance on Classification Rules for IVDs under (EU) 2017/746
9 July 2024
On 8 July 2024, the Medical Devices Coordination Group (MDCG) published the third revision of the guidance document MDCG 2020-16.
This document addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII.
The MDCG Guideline 2020-16 provides 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 EU. This guideline also contains information for regulatory authorities and other stakeholders on how to assess and evaluate the classification assigned to an IVD by a manufacturer or healthcare institution.
The main changes to the previous revision of the document include the following points:
- Addition of ‘kit’ definition
- Revision of examples for Rule 3(a) : Devices intended for detecting the presence of, or exposure to, a sexually transmitted agent
- Revision of examples for Rule 6: Class B devices
- Revision of Rule 4(a): Devices intended for self-testing
- Revision of Rule 5(c): Specimen receptacles
MDCG 2020-16 rev.3 replaces the revision MDCG 2020-16 rev.2 published in February 2023, which included amendments to Rules 1, 2 and 3 and added Annex 2.
