Essentials of European Medical Device Regulatory Affairs - June 2020

Integral Products (which are devices)

Examples:- • Catheters coated with Heparin or an antibiotic agent • Bone cements containing antibiotic • Root canal sealers which may incorporate medicinal substances with secondary action • Blood bags containing anti-coagulant • Soft tissue fillers incorporating local anaesthetics • Condoms coated with spermicides • Wound dressings with antimicrobial agent

TheOrganisation for Professionals in Regulatory Affairs

An example…………

Prefilled insulin pen • The insulin cartridge is fixed in the pen • Several injections, the entire pen is discarded once empty (medicine) the empty pen (medical device). • Several injections and once the cartridge is empty, the cartridge is discarded • A new cartridge is put into the pen Reusable insulin pen • Insulin cartridge (medicine) is put into

TheOrganisation for Professionals in Regulatory Affairs

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 i.e. 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) Article2(10) • Procedure packs 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. • Article22

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