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Medical Device Regulation: Help with classification (3/3)

Classification according to MDR, Part 3

For the scope of the MDD, the guidance document MEDDEV 2.4/1 "Classification of medical devices" provides valuable assistance on the interpretation of definitions. Likewise, the corresponding documents on borderline products provide useful advice on this topic, especially with regard to the scope of application.

As a rule, however, these documents refer to the MDD and are therefore not formally applicable to the MDR. This calls for good reasoning, showing that these documents represent the current state of the art and knowledge, taking into account the changes introduced by the MDR, and can therefore also be used as guidance for these topics within the scope of the MDR - at least as long as there are no contradictions with the new regulations or documents are published that compete with them.

 

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How about procedure packs?

Nothing has changed for manufacturers in this regard. If there are one or more non-CE-marked medical devices in the procedure pack, the manufacturer carries out a classification for each individual product. The procedure pack as a whole is then classified into the same risk class as the product with the highest risk class in the procedure set. However, the following still applies: If the procedure pack contains only products already bearing a CE mark and if the combination is compatible with the intended purpose of the products, the procedure pack does not have to bear its own CE mark as an independent product and therefore does not have to be classified.

A brief summary of the main changes

  • The former Rule 18 (blood bags) has now been integrated into Rule 2. However, the classification of blood bags as class IIb devices has not changed.
  • Rule 3 takes into account the fact that the technology of processing cells or tissues in vitro for subsequent implantation in the body has made immense progress in recent years and that an increasing number of products have been developed which must be regulated accordingly as medical devices.
  • Rule 4 now also takes into account the injured mucous membrane in addition to the injured skin and thus completes the rule. Furthermore, the rule has been extended to invasive devices that come into contact with injured mucous membrane.
  • Rules 6 and 7 close a gap: Until now, only devices for "monitoring, diagnosis, control or correction of a defect of the heart or the central circulatory system in direct contact with these parts of the body" were covered by the classification as class III devices. This did not include devices that had direct contact with these parts of the body but were not intended for monitoring, diagnosis, etc. This gap is now closed with the third indent.
  • Rule 8 now takes into account not only active implantable devices in general as class III devices but also the reclassifications of certain implants already made in the past within the scope of the MDD.
  • Rule 9 has made dedicated gradations in the active therapeutic devices and now differentiates the devices that deliver ionizing radiation for therapeutic purposes or control, direct or influence such devices and devices that control, direct or influence active implantable devices from other devices in this group.
  • Rule 10 extends the applicability of Class IIb in the third indent.
  • Rule 11 is completely new and regulates the classification of stand-alone software.
  • Rule 16 specifies products in the field of sterilization and disinfection.
  • Rule 18 now covers not only materials of animal origin but also materials of human origin.
  • Rules 19-22 have been newly included and, in addition to products made of nanomaterials, inhalation devices and products that are absorbed by or distributed in the body, also classify products that influence patient management, e.g. through closed control loops.

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