“Due to the long lifetime of medicals devices (in excess of 10 years), most are returned to the producer (or third party acting on their behalf) for repair or refurbishment outside of the warranty period making this exception critical to the medical device industry. The EU proposal introduces
geographical limits to shipments of used equipment. Used equipment designated waste would be impossible to ship from an Annex VII country to a non-Annex VII country. Furthermore, repair and refurbishing facilities do not have the authority to accept consignments designated as waste or hazardous waste. For these reason, the EU proposal is unacceptable in regions with a few Annex VII countries such as APAC, Middle East and LATAM. The medical device industry is highly regulated, requiring specialized and controlled processes for repairing, refurbishing and remanufacturing. There are a limited number of locations globally where medical devices can undergo these processes. These programs rely on transboundary movement of used professional equipment and used parts to the producer or a regional authorized service center. Singapore and China are major repair hubs, which could not accept shipments of used equipment from Japan and Korea under this proposal.
Philips believes that the destination of a shipment should not be used by Control Authorities as a criteria for distinguish between legal and illegal activities. Objective criteria based on the nature of the shipped goods, packaging, and accompanied by appropriate documentation should be preferred. Medical devices destined for repair and refurbishment are packaged with the same care as new products and accompanied with shipping documentation that show clear traceability and individual identification of each part or system in the shipment. Additional assurances can accompany consignments such as a document with owner and shipper signatures certifying the
used equipment is destined for repair or refurbishment at the producers repair facility (or third party contracted directly by the producer) and is not waste. Consignment value is objective criteria as well.
Additionally, the EU proposal would make intra-company shipments of used equipment and components (or shipments to authorized third parties acting on behalf of the manufacturer) impossible from Annex VII countries to non-Annex VII countries as some used electronics would be classified as hazardous wastes and others classified as wastes, adding red tape and burdening companies and control. Repairing used parts is critical to maintaining equipment, keeping customer repair costs down, and ensuring medical equipment servicing worldwide. Without the return flow of used parts, the cost to healthcare providers would increase by €500M annually. Furthermore, industry standards used to comply with legislation requires producers to return non-functional (defective) medical devices to the manufacturer or a regional testing center for root cause (failure) analysis.”
From p. 3 of response by Philips to Basel Secretariat. 2012. ‘Draft Technical Guidelines on Transboundary Movement of E-Waste, in Particular Regarding the Distinction between Waste and Non-Waste (Version of 27 September 2012)’. http://www.basel.int/Portals/4/download.aspx?d=UNEP-CHW-OEWG.8-INF-9-Rev.1.English.doc.