Electronic Medical Device Recovery and Recycling Targets Take Effect in Europe

The revision of the Waste Electrical and Electronic Equipment (WEEE2) Directive (2012/19/EU) came into force today in Europe. EU member states have until February 14, 2014, to transpose the directive into national law. In addition to defining products which are subject to regulation, the directive sets out target rates of recovery and recycling of waste electrical and electronic devices, including those used for medical applications.

Until now any medical equipment entering the waste stream did not have to meet any recovery and recycling targets, however from today waste medical devices will be subject to a recovery target of 70% and a recycling target of 50%. These targets will be increased on August 15, 2015, to 75% and 55% respectively.

On August 15, 2018, there will be an introduction of new equipment categories and recovery and recycling targets will increase to 85% and 80% respectively for newly categorised "large" equipment and remain at 75% and 55% respectively for "small’ equipment.

According to a report on the Eucomed website, member states are allowed to set more ambitious target rates for separate collection than that specified in the directive. The author of the report, Andy Vaughan, an environmental consultant at Ecomed, Europe's most important medical technology trade association, points out that the European Commission is empowered to update various aspects of WEEE2 in the light of technical and scientific progress via delegated acts. This is expected to give greater flexibility while making WEEE2 a much more ‘light-footed’ and dynamic piece of legislation than its predecessor.

One of the most controversial proposals in WEEE2 from the standpoint of the medical device industry was the requirements for electrical and electronic equipment (EEE) shipped across national borders. This was perceived to be a major issue as medical device companies ship non-working devices across borders all the time, whether for repair, reconditioning or investigation. There has long been a problem with EEE being shipped to developing countries under the pretext of being for ‘reuse’ when in fact it was destined for suboptimal recycling with consequent risks to those recycling hazardous products as well as the risk of pollution to the environment. The EU signed the Basel Convention on the Control of Trans-boundary Movements of Hazardous Wastes and their Disposal in 1989 and the changes to the WEEE Directive reflect that policy. Annex VI of WEEE2 gives the requirements for ‘used’ EEE that is not WEEE being shipped across borders, and amongst its requirements are evidence that the device is functional if it is not to be perceived as illegally shipped waste EEE. A derogation does exist “…where it is documented by conclusive proof that the shipment is taking place in the framework of a business-to-business transfer agreement’ for repair or for the investigation of a failure. However what constitutes ‘documented by conclusive proof’ remains to be seen and has the potential to vary from Member State to Member State.

According to the Eucomed report, WEEE2 represents a significant tightening of the legislation surrounding the disposal of waste EEE and it will be necessary for medical device producers to review the legislation and if necessary liaise with their compliance schemes on meeting the new requirements. The shipping of non-functioning EEE across borders is likely to also get more complicated though it is too early to tell what the exact implications are likely to be.

Andy Vaughan's full report is available here.