Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Resources

• MHRA guidance on the health institution exemption (HIE) – IVDR and MDR (Northern Ireland). January 2021 https://assets.publishing.service.gov.uk/government/uploads/syste m/uploads/attachment_data/file/948827/Health_institution_exempti on.pdf • Concept paper on predictive biomarker-based assay development in the context of drug development and lifecycle EMA/CHMP/800914/2016 https://www.ema.europa.eu/en/documents/scientific guideline/concept-paper-predictive-biomarker-based-assay development-context-drug-development-lifecycle_en.pdf • Reflection paper on methodological issues associated with pharmacogenomic biomarkers in relation to clinical development and patient selection EMA/446337/2011 https://www.ema.europa.eu/en/documents/scientific guideline/reflection-paper-methodological-issues-associated pharmacogenomic-biomarkers-relation-clinical_en.pdf

The Organisation for Professionals in Regulatory Affairs

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