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GUIDELINES FOR THE CLASSIFICATION OF MEDICAL DEVICES
Index:
1. PURPOSE AND PHILOSOPHY OF MEDICAL DEVICE CLASSIFICATION
2. PRACTICAL RELEVANCE OF CLASSIFICATION
2.1. General requirements
2.2. Conformity assessment
2.3. Clinical data
2.4. Labelling
2.5. Miscellaneous
3. HOW TO CARRY OUT CLASSIFICATION
3.1. Basic definitions
3.2. Application rules
3.3. How to use the rules and the decision tree
3.4. Practical example
3.5. Handling of interpretational problems
4. EXPLANATIONS OF INDIVIDUAL RULES
4.1. Graphical summary - Guidance chart
4.2. General explanation of rules/Practical issues/Examples
APPENDICES:
1. Annex IX of the Medical Device Directive
1. PURPOSE AND PHILOSOPHY OF MEDICAL DEVICE CLASSIFICATION
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 channel medical devices into the proper conformity assessment route.
In order to ensure that conformity assessment under the Medical Device Directive functions effectively from January 1995, manufacturers should be able to know as early as possible in which class their product is. Identification of the class of each individual type of device by a committee procedure would have taken too long to achieve this goal. It was therefore decided to set up a system of classification rules within the directive, so that each manufacturer could classify its own devices.
A simple set of classification rules based on technical features of medical devices existing now and in the future is impossible, because of the vast number and the changing nature of variables involved. The human body, however, is a relatively unchanging element of the equation. The European legislator established therefore a classification concept which is essentially based on potential hazards related to the use and possible failure of devices taking account of technology used and of health policy considerations. This approach in turn allows the use of a small set of criteria that can be combined in various ways: duration of contact with the body, degree of invasiveness and local vs. systemic effect.
It is recognized that although the existing rules will adequately classify the vast majority of existing devices, a small number of difficult cases may arise. Such cases may in particular include the determination of the borderline between two classes. 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.
2.2. Conformity Assessment
Graphical Summary
medical devices classification guidance chart
for initial identification of probable device class
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