What are Medical technologies?

Currently, billions of patients worldwide depend on medical technology, at home, at the doctor’s office, in the hospital and in nursing homes. This sector is set to expand even further as the average life expectancy has steadily increased in the three biggest markets, the United States, Europe and Japan. Medical devices range from simple consumables such as bandages to electrically active implantable products such as artificial hearts. Cardiovascular stents, orthopaedics knees, wheelchairs, contact lenses, to medical software used to record patient data. Eucomed estimates that there are more than half a million different product groups on the market in Europe.

How are medical technologies regulated?

All devices must adhere to stringent regulations depending on the degree of inherent risk. In Europe, there are there four general categories for distinguishing increasingly active and invasive devices; Class I, II, IIa and III. The onus is on the manufacturer, along with their chosen notified body, to agree on the classification level for their product and then to ensure it meets European standards. Manufactures or their representatives are also expected to execute a post-market surveillance system to act as a final safety measure and to report any adverse incidents directly to the local government controlled Competent Authority. The Competent Authority in Ireland is the Health Products Regulatory Authority.
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