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Home » New EU Guidance Deals with High-Risk In-Vitro Diagnostics
New EU Guidance Deals with High-Risk In-Vitro Diagnostics
High-risk “class D” in vitro diagnostics (IVDs) should get specialized handling from their manufacturers and the third-party notified bodies authorized to approve them on behalf of the EU, said the Medical Device Coordination Group (MDCG), which is made up of experts appointed by EU member states.