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Performance studies using in-vitro diagnostics (IVDR)
Standard research file IVD performance studies
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K. Other documents
This part of the file contains other documents relevant to the performance study.
K1. Assessments other institutions
K2. Assessment other EU member states
K3. Clinical trial agreements
K4. Relevant publications
K5. Data Safety Monitoring Board (DSMB) charter
K6. Other information
K7b. Performance Evaluation Plan
K8. Description of the processing of personal data
