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Re-issue of MEDDEV 2.4/1 Classification of Medical Devices guidance document now available

Changes to 93/42/EEC by the 2007/47/EC in March 2010 have been incorporated in MEDDEV 2.4/1 rev 9 June 2010.

The changes introduced by the 2007/47/EC were:

  • Definition 1.4:  confirms software can be an active medical device
  • Definition 1.7:  enlarges the scope of the central circulatory system to include the descending aorta, etc.
  • Implementing Rule 2.6:  confirms previous guidance on the interpretation of "continuous use"
  • Rules 6 and 7:  adds the word "control" to the definition of devices which are Class III because of their impact on the central circulatory system
  • Rule 13:  adds devices containing human blood derivatives
  • Rule 15:  makes devices specifically intended to be used for disinfecting invasive devices into Class 2b
  • Rule 16:  makes all devices for recording X-ray images into Class 2a (i.e. software devices).

The revision to MEDDEV 2.4/1 has taken account of these changes thus:

  • Rule 6 and 7:  it does not further explain the significance of the word "control" although it does confirm that guidewires and similar devices used in the heart etc. are Class III
  • Rules 13 and 16:  example devices are added for the changes made by 2007/47/EC
  • Rule 16:  examples are added of such products, which also confirm that both disinfectants (e.g., liquids) and disinfectors (e.g., machines) can fall under this rule.

Other issues, which were considered to be controversial and lengthy to resolve, have not been included in revision 9 of the MEDDEV. They have been referred to the Medical Devices Expert Group on Borderline and Classification for eventual inclusion in their Manual. Additional information and the manual can be found on the Borderline and Classification issues page of the EC website.

The MEDDEVs are a set of guidelines relating to questions of application of EU directives on medical devices and are not legally binding.

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