1. 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.

2. 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

3. 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.

4. 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

5. 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