The European Commission Medical Device Coordination Group (MDCG) releases regularly guidelines on the interpretation and implementation of clauses of the EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) [1]. The guidelines are typically developed in a consultative process between national competent authorities (CA), and take or take not into account opinions of invited observer stakeholders. These guidelines start with a general disclaimer that they cannot be regarded as reflecting an official position of the European Commission, that views expressed are not legally binding and that only the Court of Justice of the European Union can give binding interpretations of Union law. However, being an accepted guideline, they may stand in court as a reference to diligent good practice. Recently, MDCG-2023-1 [2], a guideline pertaining to the interpretation of art 5(5) of the IVDR [1] for implementation of laboratory developed tests (LDTs) for in-house use... Click here to download the full paper
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