Medical devices

Medical devices and in-vitro-diagnostics are out of scope of the ElektroG if they are expected to be infectious before the end of their life cycle. The same applies to active, implantable medical equipment (§ 2 paragraph 2 number 10 ElektroG). 

When an equipment is to be considered infectious and therefore is out of scope must in principle be decided individually. The following guidelines apply though:

  • A b2c equipment generally counts as infectious if the equipment is determined to be in contact with blood and 
    • fluid can collect inside the electrical or electronic equipment and can be retained for more than a few days (with b2c equipment that are meant for single use it cannot be expected that there will be a longer period between utilisation and transfer to disposal, so that the fluid could lose its pathogenic agents)
    • or the equipment can lead to the danger of injuring employees handling the equipment due to its properties/construction on dismantling.

A b2c equipment that only incidentally has contact with blood is generally not to be regarded as infectious.

Infectivity can generally be excluded for re-usable b2b electrical and electronic equipment due to the existing legal or subordinate obligations to decontaminate prior to re-use or respectively prior to transfer to disposal.

This does not apply to medical products for single use, as the above-named obligations to decontaminate do not exist to the same extent. With this electrical and electronic equipment, the infectivity must be checked in each case individually.