Essentials of European Medical Device Regulatory Affairs - June 2020

Is the Product a Medical Device?

A medical device is different to •

Cosmetic Products -Regulation 1223/2009 • Invitro diagnostics -Regulation 2017/746 • Medicinal Products -Regulation 2001/83 • Advanced therapy medicinal products - Regulation 1394/2007 • Human blood products • Biocide products • Toys • Foods - Regulation 178/2002

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Medical Device Definition: ‘medical device’ means any instrument, apparatus, appliance, software, implant , reagent , material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the followingspecific medical purposes • diagnosis,prevention, monitoring, prediction , prognosis, treatment or alleviationof disease, • diagnosis,monitoring, treatment, alleviationof, or compensation for an injury or disability , • investigation, replacement or modificationof the anatomy or of a physiological or pathological process or state , • providing informationby means of in vitro examinationof specimens derived from the human body, includingorgan bloodand tissue donations And which does not achieve its principal intended action by pharmacological, immunologicalor metabolic means , in or on the human body, but which may be assisted in its function by such means. The followingproducts shall also be deemed to be medical devices – Devices for the control or support of conception, – products specifically intended for the cleaning , disinfectionor sterilisationof devices as referred to in article1(4) and those referred to in the first paragraph of this point.

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Onecomb is for humanbeings

for the specific medical purposeof prevention,ortreatmentdisease

andother is for humanbeings tokeep theirhair tidy butdoesnothaveamedical purpose.

TheOrganisation for Professionals in Regulatory Affairs

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