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Guidance MDCG on classification for IVD MD under Regulation (EU) 2017/746

The Medical Devices Coordination Group (MDCG) has published a Guidance document MDCG 2020-16 on Classification Rules for in vitro Diagnostic (...)

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European Commission publication on EUDAMED and the module on economic actors’ registration

The European Commission has recently published on its website information dedicated to EUDAMED and more specifically information related to the (...)

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The main changes introduced by the “MDSAP AU P0002.005 Audit Approach” document

On Sept. 3, 2020 the MDSAP consortium has published a new document “MDSAP AU P0002.005 Audit Approach”. This document replaces the (...)

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