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Guidelines
  for Classification of  
Medical Devices

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FAQ- Questions & Answers on CE Marking

Other CE Publications Related to Medical Devices:
  1. 93/465/eec: Conformity Assessment Procedures & CE Marking Rules
  2. 2001 Guidelines for Classification of Medical Devices
  3. Guidelines relating to the demarcation between Directives 90/385/eec, 93/42/eec and 65/65/eec.
  4. 90/385/eec: Directive of Active Implantable Medical Devices
  5. 98/79/ec: Directive of In Vitro Diagnostic Medical Devices
  6. Guidelines to Medical Devices Vigilance System
  7. List of Harmonised (European) Standards for Medical Devices
  8. List of Notified Bodies for Medical Devices Directive
  9. Guidelines for Conformity Assessment of Breast Implants According to Directive 93/42/eec
  10. Guidelines on Assessment of Medical Devices Incorporating Materials of Animal Origin
  11. Guidelines on Medical Devices With Measuring Function
  12. Guidelines on Medical Devices: Subcontracting – Quality System Related
  13. Guidelines on Medical Devices: Treatment of Computers used to program Implantable Pulse Generators
  14. Guidelines on Medical Devices: Demarcation with other Directives- Directive 89/336/EEC EMC & Directive 89/686/EEC PPE
  15. Guidelines on Medical Devices: EMC Requirements
  16. Guidelines on Medical Devices Labelling: USE-BY DATE
  17. Guidelines on Medical Devices Labelling: Translation procedures
  18. Guidelines on Homogeneous Production Batches

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:
  • 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.
The classification rules are set out in Annex IX of the directive. This annex includes definitions of the terminology used in the classification rules.


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CONTENTS

Contents


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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.

conformity assessment procedures


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Graphical Summary
medical devices classification guidance chart
for initial identification of probable device class




Non Invasive Devices


Invasive Devices


Active Devices


Special Rules



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Please click the following links to learn more about every CE-Marking-related European Union Directive, Guidelines to Directives, Frameworks of implementation of Directives, and Agreements on Mutual Recognition of conformity assessment between European Union and other countries such as USA, Japan, Canada, Australia, New Zealand and Israel:-

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  1. Does my product need CE Marking in order to be sold/exported on/to the European Market?
  2. How to obtain CE Marking for my product?
  3. How can Wellkang Consultant Firm help me to obtain CE Marking for my product?
  4. Wellkang can be your Authorized Representative in Europe for CE Marking purpose !
  5. Buy a Directive or Guideline on Directive in Chinese, English, French, Portuguese and/or Spanish.
  6. Complete list of all CE Marking Directives and Guidelines to Directives
  7. Complete list of all (more than 1000) Notified Bodies for CE marking
  8. Complete list of all European and/or international standards related to CE marking
  9. 85/374/eec: Directive of Liability for Defective Products (for all products)
  10. 1999/34/ec: Directive of Liability for Defective Products (amending) (for all products)
  11. 2000: (Proposal for a new) General Products Safety Directive (for all products)
  12. 92/59/eec: Directive of General Products Safety (for all products)
  13. 93/68/eec: "CE Marking" Directive (for all products)
  14. 93/465/eec: Conformity Assessment Procedures & CE Marking Rules, & Annex (for all products)
  15. Guide to Implementation of directives based on new approach & global approach (for all products)
  16. 73/23/eec: Directive of Low Voltage Electrical Equipment
  17. Guideline to Low Voltage Directive (LVD) 73/23/eec & Annex I, II
  18. 2000&2001 Framework of implementation of (LVD) Directive 73/23/eec
  19. 98/37/ec: Directive of Machinery
  20. 2000: Comments on Directive of Machinery 98/37/ec
  21. Useful Facts relating to Machinery 98/37/ec
  22. 2001 Proposal to amend Directive of Machinery 98/37/ec
  23. 99/5/ec: Directive of Radio Equipment & Telecommunications Terminal Equipment (R&TTE)
  24. 2001 Framework of implementation of Directive 99/5/EC R&TTE
  25. 2001 Guidance on Directive 99/5/EC R&TTE
  26. 2000/9/ec: Directive of Cableway Installations to Carry Persons
  27. 2000/14/ec: Directive of Noise Emission in the environment by equipment for use outdoors
  28. 1999 Agreement on Mutual Recognition of conformity assessment between European Union and United States of America
  29. 2000 amendation to Agreement on Mutual Recognition of conformity assessment between European Union and United States of America
  30. 1998 Agreement on Mutual Recognition of conformity assessment between European Union and Canada
  31. 1998 Agreement on Mutual Recognition of conformity assessment between European Union and Australia
  32. 1998 Agreement on Mutual Recognition of conformity assessment between European Union and New Zealand
  33. 1999 Agreement on Mutual Recognition of conformity assessment between European Union and Israel
  34. 2001 proposal Agreement on Mutual Recognition of conformity assessment between European Union and Japan

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