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Guideline on medical Devices MEDDEV 2.4/1 rev. 9 (June 2010) INTRODUCTION It is not feasible economically nor justifiable in practice to subject all medical devices to the most rigorous conformity assessment procedures available. A graduated system of control is more appropriate. In such a system, the level of control corresponds to the level of potential hazard inherent in the type of device
concerned. A medical device classification system is therefore needed, in order to apply to medical devices an appropriate conformity assessment procedure. In order to ensure that conformity assessment under the Medical Device Directive functions effectively, manufacturers should be able to determine the classification of their product as early as possible in device development. It was therefore decided to set up a system of classification rules within the Directive, so
that each manufacturer could classify its own devices. The classification of medical devices is a ‘risk based’ system based on the vulnerability of the human body taking account of the potential risks associated with the devices. This approach allows the use of a set of criteria that can be combined in various ways in order to determine classification, e.g. duration of contact with the body, degree of invasiveness and local vs. systemic effect. These criteria can then be applied to a vast range of different medical devices and technologies. These are referred to as the ‘classification rules’ and are set out in Annex IX of Directive 93/42/EEC . They correspond, to a large extent, to the classification rules
established by the Global Harmonization Task Force (GHTF) in the guidance document GHTF/SG1/N15:2006 . It is recognized that although the existing rules will adequately classify the vast majority of existing devices, a small number of products may be more difficult to classify. Such cases may in particular include devices which are borderline cases between two different classes of medical devices. In addition there may be
devices that cannot be classified by the existing rules because of their unusual nature or situations where the classification would result in the wrong level of conformity assessment in light of the hazard represented by the device. The MEDDEV is available in our library. Or may be downloaded directly here: MEDDEV 2.4/1 rev. 9
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