Regulatory barriers for the circular economy Case study

Regulatory barriers for the circular economy Case study: Remanufacturing of medical equipment Natalia Duque Ciceri, thinkstep

Overview Landfill Recovery, Recycling Treatment as EEE waste; disassembling End-of-life Use of spare parts in new products Collection, quality assessment Reuse, repair, maintenance, refurbish Collection by OEM (time lag) Import Extraction Production Use in hospitals Competition point Regulative barrier Conventional stream Circular stream 2

Regulatory barrier • Restriction of Hazardous Substances (Ro. HS) and Medical Device Directive (MDD) limit access to used equipment and parts sourced outside of the EU • • For medical imaging certain substances are needed to provide good accurate diagnosis The interpretation of the term “placing on the market” according to the Blue Guide causes issues related to Ro. HS and MDD with the sourcing of products from outside the EU 3

Effects of regulatory barrier • Economic effects • EU producers: loss of 30% of revenue cuts or potential business losses • Estimated global expenditure for Ro. HS compliance since 2006: 2 bn. Euros • Eventually, more access to used equipment can lead to cheaper healthcare in the EU • Environmental effects • Resource inefficiency – favors recycling/landfill over refurbishment/ reuse • Refurbishment case: limited access to used parts and equipment • Reuse case: inability to used parts in new products (usable parts become obsolete) 4

Observations on removal of regulatory barrier • Exemptions are only temporary, have to be adapted and renewed which takes a lot of time and resources • If imaging devices are considered “large-scale fixed installations” then Ro. HS would not apply • Once a product or component reaches its end-of-life, it is treated by a network of disassembly and recycling facilities under high quality standards - controlled by the OEM’s • Generally, refurbished equipment compete with new equipment though OEM’s produce and refurbish • A refurbished product can be up to 20% cheaper than a new product 5