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Europe Regulation BioPharmaceutical

EMA To Tackle Inconsistencies In Quality Data For Drug-Device Combinations

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Executive Summary

The European Medicines Agency believes guidance is needed on the quality aspects of drug-device combinations to show that these products are appropriately designed and can be used correctly in their intended clinical situations.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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