The guidance document MDCG 2020-16 has been recently updated. To offer some background to this guidance document, originally published in 2020, this guidance document provides clarification on the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR), focusing on Annex VIII classification rules. It applies to diagnostic services performed on EU patients, including those offered via distance sales. Developed by an expert group including Member State authorities, the European Commission, notified bodies, and industry representatives, the guidance incorporates updates from the 2019 Corrigendum.
Its primary purpose is to assist manufacturers, notified bodies, and health institutions in classifying IVDs before market placement or use in the EU. It also serves as a reference for regulators assessing classifications assigned by manufacturers or institutions. The IVDR legally empowers the European Commission, in consultation with the Medical Device Coordination Group (MDCG), to determine classifications and address interpretation issues through implementing acts (Article 47).
The document includes illustrative examples but does not provide an exhaustive list of classifications. This revision includes the following updates
- Rule 1 (Transmissible Agents): Revision of examples
- Rule 3m (Congenital Disorders): Revised footnote 8 for greater clarity.
- Rule 4a (Self-Testing): Updated examples of self-testing devices.
- Rule 6 (Devices Not Covered by Other Rules): Adjusted rationale and classification examples.
- Annex 1 & 2: Editorial refinements to enhance guidance application.
The updated guidance can be accessed using the following link
