Essentials of European Medical Device Regulatory Affairs - October 2019

Legislation of Combination Products

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Devices MDD/MDR

Drugs: 2001/83/EC

Physical

Stent

Drug eluting stent

Sirolimus

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Legislation of Combination Products Products should be regulated either by the device or medicines review process.   Not both . Combination devices under the MDR: • Meets the definition of a medical device and • Incorporates a substance which meets the definition of a drug and • The action of the substance is ancillary to that of the primary action of the device Examples: Included : Drug eluting stent Excluded: Antimicrobial wound contact layer –primary purpose is the medicinal action Borderline: haemostats

Combination devices under the MDR are class III under rule 14

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