Essentials of European Medical Device Regulatory Affairs

Legislation of Combination Products

Combination devices regulated as a device • 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

Combination devices under the MDR are class III under rule 14

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Legislation of Combination Products The Notified Body must: • Review the technical file (information on the device) • Verify the usefulness of substance as part of the device • Seek an opinion of: • Medicines authority/EMA issues an opinion (within 210 days) • NB “due consideration” to opinion when making certification decision - No CE certificate if opinion is unfavourable - NB must inform Medicines Authority of final decision - a medicines authority (EU member state) - or the European Medicines Agency (EMA)

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