Medical devicesEU: Amendments to the Medical Devices Regulation

Draft Commission Implementing Regulation laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 (Medical Devices Regulation) on medical devices was published.

Generally, the Medical Devices Regulation applies to medical devices for human use and accessories for such devices in the Union.  However, it shall also apply, as from the date of application of the so called common specifications, to the groups of products without an intended medical purpose that are listed in Annex XVI, taking into account the state of the art, and in particular existing harmonised standards for analogous devices with a medical purpose, based on similar technology.

The common specifications for each of the groups of products listed in Annex XVI shall address, at least, application of risk management as set out in Annex I for the group of products in question and, where necessary, clinical evaluation regarding safety.

These common specifications were just published in a draft form

Examples for those Annex XVI products with common specifications are cosmetic contact lenses; implants without medical purpose; facial, dermal or mucous membrane fillers; liposuction equipment; intense pulsed light or laser equipment for hair removal and brain stimulators.