MedTech Europe issued an MDR/IVDR statement after EPSCO meeting discussing the MDR and IVDR. Whereas clinical evidence forms the foundation of patient and user safety, clinical is not mentioned anywhere. While supporting this statement in general, the phrase that the EU commission should act swiftly – indeed they should – and implement solutions to “Significantly […]
Lees meerhttps://health.ec.europa.eu/document/download/daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en?filename=mdcg_2024-10_en.pdf By nature ‘orphan devices’ are intended for use in a small number of individuals. This leads to specific challenges for manufacturers and notified bodies on the clinical evidence requirements for the purposes of MDR certification. This MDCG guideline presents guidance on circumstances where it is acceptable to place an orphan device on the market […]
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