EU Commission: Spare Parts in Medical Devices May No Longer Contain Harmful Substances

The EU Commission has modified Annex IV of Regulation 2011/65/EU to limit the use of certain harmful substances in electric and electronic devices. Annex IV of the regulation states that spare parts that contain such materials may no longer be installed in imaging devices like MRI devices, computer tomography, in-vitro diagnostics, patient monitoring devices, and electron microscopes. Up to now, an exception applied to such materials. The harmful substances include heavy metals (lead and cadmium), hexavalent chromium, and polybrominated diphenyl ether (PBDE).

Because medical imaging devices are so expensive, appropriate spare parts management along with a repair service has proven itself helpful. But given that the spare parts contain small quantities of the harmful substances noted here, their use has now been stopped and the exception overturned. As a result, the availability of spare parts has become limited.

Nonetheless, Article 4(3) of Regulation 2011/65/EU limits the use of harmful substances in such devices as of specific dates for different types of devices:

• July 21, 2021 for medical devices except those used in in-vitro diagnostics

  

• July 21, 2023 for in-vitro diagnostics
• July 21, 2024 for electron microscopes and their accessories

If you are affected by these changes and have any questions about them, please contact us at any time at reach@kft.de.