Medical device CE marking

New European manual on borderline and classification for medical devices and IVDs

2022-09

The European Commission has published an 18-page manual on borderline and classification for medical devices under the Medical Devices Regulation and IVD Regulation. This version 1 is a working document, and is described as a support tool and not a legal document, also not one that represents the opinions of the commission. The views represent agreements reached by the competent authorities of the member state members of the Borderline and Classification Working Group (BCWG), this is a subgroup of the Medical Device Coordination Group (MDCG).

The document can be downloaded in our library

Source: European Commission