Essentials of European Medical Device Regulatory Affairs - October 2019

Products Together in a Carton/Procedure Packs Medicinal products with a device

• e.g. a medicine(antibiotic) with a device (dosing spoon) • Present the submission as per the common technical document ie MAA. • Provide a copy of the CE certificate for the device. • Introducing a new device or device supplier is a Type 1B variation Procedure packs (more than one device) • Procedure packs per Article 12 of Directive 93/42/EEC each device keeps its own classification. • If pack includes devices without a CE mark, or combination is not compatible with original intended use, the pack is a device in its own right.

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IVD examples

IVD • Pregnancy testing kits • Specimen collection tubes • Blood analysis (ABO, rhesus) • Companion diagnostics ----------------------------------------- Not IVD • Research use only – biomarkers • Breathalyzers • Laboratory reagents (unless diagnostic)

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