Module 18 - Drug Device Combinations and Other Technologies

Risk Classification

Low Risk : General IVDs, Plasters, Walking Sticks, Wheelchairs, Stethoscopes, Medicine Spoons, Administration Sets, Syringes, Re usable Surgical Instruments Medium Risk: Needles, Dental Filling Materials, Contact Lenses and Solutions, Diagnostic and Monitoring Equipment, Self Test IVDs, Condoms, Infusion Pumps, Blood Bags, Haemodialysis Concentrates, Hearing Aids, Ventilators, Incubators, Surgical Lasers, Anaesthetic Machines, Nebulisers, Specified IVDs (egRubella, Chlamydia, PSA, Downs Syndrome) High Risk: Pacemakers, Cochlear Implants, Breast Implants, Devices containing Medicinal Substances, Devices containing Animal Materials, Cardiovascular and Devices, Neurological Implants, Absorbable Sutures, IUDs, HIV and Hepatitis Test Kits, Blood Grouping Reagents

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Classification

If it is a Medical Device..

• Is it an IVD, MD or AIMD?

• How long is it intended to be used for? • Is it invasive? • Is it implantable? • Is it ‘active’? • How does it work? (physically?) • Does a ‘special’ rule apply?

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