| Abstract |
The medical sector has requested an exemption from the substance restrictions of Directive 2011/65/EU (RoHS 2) for refurbished devices. Through global refurbishment practices, many of the larger medical devices are collected, refurbished and then resold to new end-users. Such practices are particularly of interest at present, in light of their contribution to the circular economy. Refurbishment prolongs the service lives of products, giving added benefit to resources that have already been used, as well as to the end-users who purchase them. According to the RoHS Directive, the first time placement on the EU market requires a device to be compliant with the substance restrictions. After this initial compliance, secondary market operations are not limited, as long as the product was compliant the first time placed on the EU market. However in a global practice, sometimes refurbished devices are imported to the EU requiring compliance with substance restrictions that may not have been relevant at the time of production. In some cases, parts may be harvested to be refurbished and used for the repair of other devices. When such parts are placed on the EU market, their compliance may need to be reestablished in some cases. However, refurbishment is often perceived to be a positive practice with both environmental, health, and economic benefits, and in this sense a first exemption has been granted. Refurbished medical devices are often resource intensive, meaning that prolonging use increases the marginal benefit of resources already used. From an economic perspective, the refurbished practices allow end-users to purchase additional devices or a newer model at lower prices, allowing the provision of better services to patients. Manufacturers, who in many cases operate OEM refurbishment, do not perceive the practice as a threat to sales of new devices, as purchasing customers would usually not be able to allocate the budget needed for a new device. In the context of the RoHS Directive, the medical device refurbishment practice is an interesting case study for learning as to aspects to be considered when developing refurbishment practices in other sub-groups of the electronics sector. Aspects shall be discussed beyond the realm of hazardous substances and their substitution, since impacts on health, on the environment and on the safety of consumers are also of importance in the context of the RoHS Directive. |