It is very important to determine:
• if your product is a Medical Device
• if it is a MD or an In Vitro MD,
• which class it is
because it determines what you have to do before you may sell the product (CE-Routes) on the Community Market.
Medical Device
• Definition [MDD]:
‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be
used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
• Determine with help of MedDev 2.1/6 the first Flow, if your product is a MD or not.
In Vitro Medical Device
• Definition [IVDD]:
‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used
alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally
for the purpose of providing information:
— concerning a physiological or pathological state, or
— concerning a congenital abnormality, or
— to determine the safety and compatibility with potential recipients, or
— to monitor therapeutic measures.
Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for
in vitro diagnostic examination;
• Determine with help of MedDev 2.1/6 the second Flow, if your product is a MD or IVD.
Determine the Class
• For MD use: MedDev 2.4/1
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Class I, Is, Im : medical devices with a low risk
(special sub-class for Sterile and with Measurement function) -
Class IIa, IIb : medical devices with a medium risk
-
Class III : medical devices with a high risk
• For IVD use: IVDD Annex II
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Being on List A or B : IVD medical devices with a high risk
-
Not being on List A or B : medical devices with a low risk
(special sub-class for Self-test)