MDCG Guidance on Article 5 (5) of MDR & IVDR!

The Medical Devices Coordination Group (MDCG) has issued a guidance on Article 5(5) of the Medical Devices and In Vitro Diagnostics devices regulations. Thus, this document's scope concerns medical devices manufactured and used within EU health institutions (referred to as in-house devices) to assess the needs of target patient groups that cannot be met by an equivalent CE-marked device available on the market. In this respect, these devices are exempted from the conditions in . . .


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