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The European Directive on WEEE: Relevant for Medical Equipment Donations

Learn about the European WEEE Directive and its impact on medical equipment donations to low-income countries. Understand the obligations and requirements for NGOs distributing second-hand medical devices. Compliance is crucial to prevent shipment of faulty equipment.

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The European Directive on WEEE: Relevant for Medical Equipment Donations

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  1. The European Directive on WEEE :Whyisit relevant to medicalequipment donations to low- income countries? Cathy Blanc-GonnetDirectorNGO Humatem, FRANCE 4th WHO Global Forum on MedicalDevices, Visakhapatnam, India, 13-15/12/2018

  2. The European WEEE Directive • European Directive 2012/19/UE on Waste Electrical and Electronic Equipment (WEEE) • Has replaced the Directive 2002/96/EC • Forming part of the EU’s environmental and sustainability agenda • Transposed in the national law of eachEuropean country

  3. To fight against the growing waste stream… By reducing the disposal of WEE By encouraging : • Recycling • Re-use

  4. … And to preventshipment of faultyequipment

  5. Why are medicalequipment donations concerned ? • Medical devices are one of the 10 product categories of electrical and electronic equipment covered by the directive. >>> The directive has clear consequences on the re-use and transfer of medical devices >>> It directly concerns the NGOs involved in the distribution of second-hand medical devices to LMIC

  6. What are the new obligations to meet ? • Obligations and documents to provide are detailed in the Annex VI “minimal requirements for shipment” • Principle: the holder must prove that the equipment he wants to send is a used EEE andnot a WEEE

  7. HOW TO PROVE THE MEDICAL EQUIPMENT IS AN EEE AND NOT A WEEE ?

  8. HOW TO PROVE THE MEDICAL EQUIPMENT IS AN EEE AND NOT A WEEE ?

  9. HOW TO PROVE THE MEDICAL EQUIPMENT IS AN EEE AND NOT A WEEE ? To be fixed securely on the equipment itself or on the packaging/load

  10. HOW TO PROVE THE MEDICAL EQUIPMENT IS AN EEE AND NOT A WEEE ? To be fixed securely on the equipment itself or on the packaging/load

  11. HOW TO PROVE THE MEDICAL EQUIPMENT IS AN EEE AND NOT A WEEE ? EEE To be fixed securely on the equipment itself or on the packaging/load

  12. Whowillverify compliance with the requirements? • Inspection and monitoring are likely to be implemented by national authorities • Sanctions mayoccur in case of transfer of WEEE (enforced return)

  13. Key take home messages • The directive should have a positive impact on the technical quality of medical equipment donations by impeaching the shipment of faulty second hand equipment • NGOs have to comply with the new regulation (measures are legally binding) • LMIC must require from their development partners to comply with this new regulation • Shipment of defective medical equipment from Europe has now become illegal. 5 other documents Testingcertificate Appropriate packaging

  14. Collective publicationavailable in French and English on Humatem’s Centre of resourceswww.humatem.org cathy.blanc-gonnet@humatem.org

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