for Classification of
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Depending on its Intended Purpose, a medical device may be classified as Class I (including Is & Im), Class IIa, IIb and III, with Class III covering the highest risk products. The higher the classification the greater the level of assessment required. All Class Is, Im, IIa, IIb and III medical devices require the intervention of third party: the so-called Notified Body.
Classification of a medical device will depend upon a series of factors, including:
The classification rules are set out in Annex IX of the directive. This annex includes definitions of the terminology used in the classification rules.
- how long the device is intended to be in continuous use
- whether or not the device is invasive or surgically invasive,
- whether the device is implantable or active
- whether or not the device contains a substance, which in its own right is considered to be a medicinal substance and has action ancillary to that of the device.
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.
medical devices classification guidance chart
for initial identification of probable device class
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- 85/374/eec: Directive of Liability for Defective Products (for all products)
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- 2000: (Proposal for a new) General Products Safety Directive (for all products)
- 92/59/eec: Directive of General Products Safety (for all products)
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- 93/465/eec: Conformity Assessment Procedures & CE Marking Rules, & Annex (for all products)
- Guide to Implementation of directives based on new approach & global approach (for all products)
- 73/23/eec: Directive of Low Voltage Electrical Equipment
- Guideline to Low Voltage Directive (LVD) 73/23/eec & Annex I, II
- 2000&2001 Framework of implementation of (LVD) Directive 73/23/eec
- 98/37/ec: Directive of Machinery
- 2000: Comments on Directive of Machinery 98/37/ec
- Useful Facts relating to Machinery 98/37/ec
- 2001 Proposal to amend Directive of Machinery 98/37/ec
- 99/5/ec: Directive of Radio Equipment & Telecommunications Terminal Equipment (R&TTE)
- 2001 Framework of implementation of Directive 99/5/EC R&TTE
- 2001 Guidance on Directive 99/5/EC R&TTE
- 2000/9/ec: Directive of Cableway Installations to Carry Persons
- 2000/14/ec: Directive of Noise Emission in the environment by equipment for use outdoors
- 1999 Agreement on Mutual Recognition of conformity assessment between European Union and United States of America
- 2000 amendation to Agreement on Mutual Recognition of conformity assessment between European Union and United States of America
- 1998 Agreement on Mutual Recognition of conformity assessment between European Union and Canada
- 1998 Agreement on Mutual Recognition of conformity assessment between European Union and Australia
- 1998 Agreement on Mutual Recognition of conformity assessment between European Union and New Zealand
- 1999 Agreement on Mutual Recognition of conformity assessment between European Union and Israel
- 2001 proposal Agreement on Mutual Recognition of conformity assessment between European Union and Japan
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