MDR IVDR (certyfikat CE) w upmedic

upmedic nie jest wyrobem medycznym i nie musi nim być, wobec czego nie potrzebuje certyfikatu CE

Dlaczego upmedic nie musi być wyrobem medycznym (Medical Device Software MDSW)? 

European Commision definiuje 5 punktów sprawdzających klasę urządzenia: 

Krok 2

• NIE SPEŁNIAMY MDR Annex XVI device

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 human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.

3. Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.

4. Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.

5. High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.

6. Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745#L_2017117EN.01017301

• upmedic NIE SPEŁNIA an ‘Accessory’ for a medical device according to Art. 2(2) of the MDR

accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s) https://www.medical-device-regulation.eu/2019/07/10/mdr-article-2-definitions/

• upmedic NIE SPEŁNIA IVDR (chodzi o in vitro)

• upmedic NIE SPEŁNIA software driving or influencing the use of a (hardware) medical device

Krok 3

odpowiedź "yes"

Krok 4

Kalkulatory nie dają wartości dodanej dla pacjentów a wspierają lekarzy (ułatwiają im liczenie skal medycznych), odpowiedź "No"

Podsumowanie

Odpowiedź "no" na diagramie dla kroku 4 sprawia, że konkluzją jest "not covered by the medical devices regulations" co sprawia, że upmedic nie musi być certyfikowanym wyrobem medycznym.