medical device – any tool, apparatus, appliance, software, implant, reagent or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or several of the following specific medical purposes:
– diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a 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 specimens derived from the human body, including organ, blood and tissue donations, 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.
active device – any device whose activity is based on a source of energy other than generated for this purpose by the human body or by gravity and which acts by changing the density or by converting this energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant modification, are not considered active devices. Softwares are also considered active devices.
implantable medical device – any medical device which is intended:
– to be totally inserted into the human body; or
– to replace an epithelial surface or the eye surface, through clinical intervention, and which is intended to remain inside the human body following the intervention.
Any device intended to be partially inserted into the human body through a clinical intervention and to remain inside the body after the procedure for at least 30 days is also considered an implantable device.
in vitro medical device – any medical device which is a reagent, reagent product, calibrator, control material, kit, tool, apparatus, piece of equipment, software 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 mainly for the purpose of providing information on one or more of the following:
– concerning a physiological or pathological process or state;
– concerning a congenital, physical or mental impairment;
– concerning the predisposition to a medical condition/disease;
– to determine the safety and compatibility with potential recipients;
– to predict the response or reactions to treatment;
– to define/monitor therapeutic measures.
Specimen containers are also considered in vitro diagnostic medical devices.
companion diagnostic device – a device which is essential to the safe and effective use of an appropriate medicinal product for the purpose of:
– identification, before and/or during treatment, of patients who can benefit the most from the appropriate medicinal product; or
–identification, before and/or during treatment, of patients with potential increased risk of serious adverse reactions following treatment with the respective medicinal product.
Classification of medical devices
Medical devices are classified into four risk classes: I, IIa, IIb and III, taking into account the proposed purpose of the devices and their inherent risks.
Class I is associated with low risk and class III with the highest risk. The manufacturer of class I devices is responsible for the assessment of conformity in order to apply the conformity CE marking.
For medical devices belonging to classes I – placed on the market under sterile conditions, I – with a measuring function, IIa, IIb and III, the manufacturer must contact a notified body for assessment of the medical device’s compliance with the legislation in force.
MDCG 2021-24 Guidance on classification of medical devices (https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf) shall be observed for the purpose of classification of medical devices.
In vitro diagnostic medical devices (IVD)
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (IVDR) enters into force starting with 26 May 2022 and introduces a rule-based classification system for IVD.
IVDs shall be classified into four different classes, depending on the risk, class A (low risk), B, C, D (high risk) and their regulation and assessment is carried out according to the degree of risk.
In the classification of in vitro diagnostic medical devices (IVD), MDCG 2020-16 rev.1 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 shall be taken into account (https://health.ec.europa.eu/system/files/2022-01/md_mdcg_2020_guidance_classification_ivd-md_en.pdf)