MDR CLASSIFICATION DOCUMENT according to MDR ANNEX VIII
Properly classify your device is the most important step toward transitioning to MDR.
This document wll provide guidance to confirm your product is a medical device.
Medical Device are defined according to article 2 as:
(1) ‘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 following specific medical purposes:
|—||diagnosis, prevention, monitoring, prediction, prognosis, treatment oralleviation of disease,|
|—||diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,|
|—||investigation, replacement or modification of the anatomy or of a
physiological or pathological process or state,
|—||providing information by means of in vitro examination of specimensderived from the human body, including organ, blood and tissue
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
|—||devices for the control or support of conception;|
|—||products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.|
This document helps define the risk classification of your medical device according to MDR annex VIII and MDCG 2021-24
As first step Duration of Use needs to be defined
1. DURATION OF USE
1.1. ‘Transient’ means normally intended for continuous use for less than 60 minutes.
1.2. ‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days.
1.3. ‘Long term’ means normally intended for continuous use for more than 30 days.
Second the product needs to be checked against the following definition
INVASIVE AND ACTIVE DEVICES
2.1. ‘Body orifice’ means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.
2.2. ‘Surgically invasive device’ means:
|(a)||an invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; and|
|(b)||a device which produces penetration other than through a body orifice.|
2.3. ‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.
2.4. ‘Active therapeutic device’ means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability.
2.5. ‘Active device intended for diagnosis and monitoring’ means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities.
2.6. ‘Central circulatory system’ means the following blood vessels: arteriae pulmonales, aorta ascendens, arcus aortae, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior and vena cava inferior.
2.7. ‘Central nervous system’ means the brain, meninges and spinal cord.
2.8. ‘Injured skin or mucous membrane’ means an area of skin or a mucous membrane presenting a pathological change or change following disease or a wound.
Device needs then to be classified according the 22 rules provided in Annex VIII.
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