Module 18 2021

Risk Classification - IVDs

• There are 4 main groups of IVD medical devices: “General” IVDs – considered low risk IVDs for self-testing – medium risk

Annex II, List B – high risk Annex II, List A – high risk

• Which class a device fits into is determined by the intended purpose and whether it is listed in Annex II.

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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 (eg Rubella, 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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