EU: MDCG releases IVD classification guidance
The European Commission’s Medical Device Coordination Group (MDCG) released a guidance on the classification of in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR). The guide provides industry a clarification on how to accurately classify diagnostics under the IVDR’s risk-based classification system.
“In particular, the conformity assessment route is highly dependent on classification, which is reflected in concepts such as conformity assessments scrutiny of class D devices (Article 50), the involvement of the European Union reference laboratories for high-risk devices (Article 100) and a consultation with a national medicines agency or the European Medicines Agency (EMA) for companion diagnostics (Article 48(3)),” the guidance states.
Contact Meditrial for a free consultation regarding your IVD and how to get ready for the conformity assessment! With international presence and complete range of services, Meditrial is a leading Clinical Research Organization (CRO), a full-service partner for clinical investigations, digital clinical solutions and market access pathways.
For more details, please see the guidance from the MDCG
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
