Regulatory barriers for the circular economy Case study: Remanufacturing of medical equipment Natalia Duque Ciceri, thinkstep Im going to talk about the case on remanufacturing of medical equipment the outcome from the interviews conducted with the industry association, main producers and remanufactures as well as one from the custumer side, a public hospital in Germany.

Overview Extraction Production Use in hospitals Collection, quality assessment Treatment as EEE waste; disassembling Reuse, repair, maintenance, refurbish Recovery, Recycling Collection by OEM (time lag) End-of-life Use of spare parts in new products Import Landfill This graph represents the life cycle of medical equipment from extraction of materials throuh production, use and the different end of life options… Conventional stream Circular stream Regulative barrier Competition point

Regulatory barrier Restriction of Hazardous Substances (RoHS) 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 RoHS and MDD with the sourcing of products from outside the EU The regulatory barrier is embedded in the RoHS and the MDD through the limitation to acess used medical equipment and functional parts that are sourced outside of the EU. according to the interviewed companies – the interpretation of the term „placing on the market“ according to the Blue Guide is one of the main issues related to these two regulations.

Effects of regulatory barrier Economic effects EU producers: loss of 30% of revenue cuts or potential business losses Estimated global expenditure for RoHS 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 use used parts in new products (usable parts become obsolete) In regards to economic effects, EU producers reported loss of 30% of revenue cuts they estimate, that Since 2006, 2 billion Euros to be the global expenditure for implementation of RoHS It is claimed that without this barrier, eventually, more access to used equipment can lead to cheaper healthcare in the EU On the other hand, in terms of the environment, resource inefficiency is the main effect – limited access to used parts and equipment hinders refurbishment and reuse and therefore less efficient end of life options such as recycling are favored with this barrier

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 RoHS 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 And finally, some observations on the removal of this barrier There are actually exemptions for which companies can apply – they report that these are only temporary … Medical imaging equipment are for the most part “large-scale fixed installations” but they are not considered as such under RoHS And last but not least, …. An observation worth mentioning is that