Essentials of European Medical Device Regulatory Affairs - June 2020

As a medical device, compliance to the regulation is needed and then a CE mark can be attached.

Having a CE mark, does not mean this toy penguin is a device

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• 1.Contact lenses or other items intended to be introduced into or onto the eye. • 2. Products intended to be totally or partially introduced into the humanbody through surgically invasive means for the purposeofmodifying the anatomyor fixation of bodypartswith the exceptionof tattooingproductsandpiercings. • 3.Substances,combinations of substances,or items intended to beused for facial or otherdermal or mucousmembrane filling by subcutaneous,submucousor intradermal injection or other introduction, excluding those for tattooing. • 4. Equipment intended to beused to reduce, remove or destroyadipose tissue, such as equipment for liposuction, lipolysis or lipoplasty. • 5.High intensity electromagnetic radiation (e.g. infra-red,visible light andultra-violet) emitting equipment intended for use on the humanbody, including coherentandnon-coherent sources, monochromatic andbroad spectrum,such as lasers and intense pulsed light equipment, for skin resurfacing, tattooor hair removalor other skin treatment. • 6. Equipment intended for brain stimulation thatapply electrical currentsor magnetic or electromagnetic fields thatpenetrate the cranium tomodify neuronalactivity in the brain.

This Regulation shallalso apply, as from the date of application of common specifications The necessarycommon specifications shall be adopted by 26 May 2021. They shall apply as from six months after the date of their entry into forceor from 26 May 2021, whichever is the latest.

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Device or Medicine ?

Consider the manufacturer’s claim

• Device – NOT by pharmacological, immunological or metabolic means • Medicine – correcting or modifying physiological functions

Device action tends to be physical e.g. a support or barrier.

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