What is a Medical Device?

Before a Medical Device can be placed on the market it must be appropriately CE marked.

What is a Medical Device?

Medical Devices are used on a daily basis within the dental practice, but what constitutes a 'Medical Device'?

A Medical Device is defined by the Medical Device Directive as:

'... an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body'.

Before a Medical Device can be placed on the market it must be appropriately CE marked. This is done in accordance with the Directive. For most devices this necessitates the involvement of a 'Notified Body' who are authorised to assess the safety and performance of the device. Only after the product's technical file has been assessed by a Notified Body can a CE mark be affixed to the product.

Medical Devices in the UK are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) which is an executive agency of the Department of Health.