European Commission’s Dashboard about reprocessing of medical devices
The concept of “reprocessing” in the context of medical devices refers to the process of safely preparing a used device for reuse through cleaning, disinfection, sterilization, and related procedures. The European Commission’s Directorate-General for Health and Food Safety commissioned a study to evaluate the implementation of Article 17 of the MDR on the EU market. As part of the study, a dashboard has been developed to provide an overview of mapping activities related to the reprocessing and reuse of single-use devices in the EU.
The term “reprocessing” denotes the procedure undertaken on a previously used medical device to ensure its safe reuse. This process encompasses cleaning, disinfection, sterilization, and associated steps, along with testing and reinstating the technical and functional integrity of the device.
In delineating the criteria for reprocessing and subsequent reuse of single-use devices, the Medical Devices Regulation (EU) 2017/745 (MDR) explicitly employs the term “reprocessing.” Conversely, when establishing requisites for reusable devices, the Regulation refrains from using the term “reprocessing” and instead refers to “appropriate processes” to allow for reuse, including cleaning, disinfection, packaging, and, when necessary, validated sterilization methods specific to the Member State(s) where the device is placed on the market.
While single-use devices are designed by the manufacturer for a one-time use, reusable devices are intended for multiple uses post undergoing proper procedures such as cleaning, disinfection, and sterilization. Consequently, the MDR stipulates distinct responsibilities and criteria for reprocessing single-use devices versus reusable ones.
The European Commission’s Directorate-General for Health and Food Safety commissioned a comprehensive study to assess the implementation of Article 17 of the MDR within the EU market. This study, conducted over 14 months by a consortium led by the Austrian National Public Health Institute, aims to evaluate the execution of MDR provisions across European countries.
As part of this study, a dashboard has been developed to provide a summary of mapping activities related to the reprocessing and reuse of single-use devices within the EU.
Access to dashboard: