Are EU Regulations Ready to Allow Circularity in Digital Healthcare Devices?

Figure 1: European countries and their regulatory status on the authorization (or not) of reprocessing of single-use medical devices.

Brought to you by Sonia Valdivia, Adrien Specker from World Resources Forum and Maria Anta from the WEEE Forum 

In light of the European New Green Deal and the Circular Economy Action Plan, regulations’ alignment with the advancement of circular economy in European policies is growing and some laws are already in place such as:

These regulations promote increased circularity through reuse, repair, reprocessing, remanufacturing and recycling.  

As for circular electronics,

Improving circularity is becoming essential and a crucial step in business practices not only due to regulatory and social pressures, but also due to growing supply chain risks and increasing costs of critical and strategic raw materials and end-of-life services. 

International standards play also a key role in harmonising processes towards the recovery of resources. The recently published ISO 59020 standard on Circularity Indicators and the upcoming ISO 59014 on Sustainability and traceability of secondary materials recovery are also worthwhile to be considered. These standards have been developed following a multi-stakeholder-based approach with a strong and active participation of National Standardisation Bodies including the European delegations. 

A key question is to what extent these directives and regulations contribute in practice to the circular flow of resources in the context of single-use digital devices.  

The ‘Digital Health in the Circular Economy’ (DiCE) project aims to shed light on this question, given that the healthcare sector must transition from a single-use and make-use-dispose mentality to a circular economy vision. Main circular pathways covered by DiCE include reuse and reprocessing the devices or recycling of materials. 

A preliminary assessment of the directives and regulations developments shows us that the reuse or reprocessing of single-use digital devices are not sufficiently covered in the existing European Union (EU) legislations and policies. In the EU Medical Device Regulation (MDR) ((EU) 2017/745), the cornerstone governing the production and management of the medical devices, reprocessing refers to ‘…a process carried out on a used device in order to allow its safe reuse. Reprocessing includes its cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device.’   

 Despite this improvement in clarity on the definition of reprocessing, this is not enough to operationalize its application at national levels as this is left to the prerogative of the countries. This explains the differences among European countries when it comes to reprocessing. 

National examples with more pro-active policies for promoting reprocessing (see Figure 1) can inspire future developments at EU level. 

At national level, it was identified that: 

  • Not all countries have developed regulations that clearly authorise the reprocessing of single-use devices (see countries in red in Figure 1).  
  • Countries that do authorise the reprocessing of single-use devices (see those in green in Figure 1) present differences on how cumbersome or simplified the process can be conducted. For example, while both Germany and the Netherlands permit reprocessing, the formalities required appear to be more challenging to comply with in the Netherlands than in Germany. 
  • There are still countries where policies and regulations on the matter are either still being developed or have not yet been discussed (see those in grey in Figure 1). 

In light of the aforementioned considerations, the DiCE project aims to further investigate political and regulatory barriers to provide policy recommendations that enable a level playing field for the development of circularity in digital health devices.  

Do you have any feedback and updates regarding the map? Contact us at info@circulardigitalhealth.eu! 

Nanett Kalapos
June 27, 2024