12 June 2024

Implementing Article 17 of EU Medical Device Regulation: A Step Towards Harmonized Practices

Research on the reprocessing of single-use devices (SUDs) in the EU was commissioned by the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) to evaluate the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices. The study, which began in December 2022 and lasted for 14 months, was carried out by a consortium headed by Gesundheit Österreich GmbH (GÖG) in cooperation with Civic Consulting, S&P Global, and Areté. Its objective was to evaluate the situation, difficulties, and possible solutions for reprocessing SUDs throughout Europe.

The research sought to address three primary questions:

What is the current situation in the EU regarding the reprocessing of single-use devices (SUDs)?

What obstacles and challenges may affect the reprocessing of SUDs in EU?

What potential solutions and recommendations could address identified issues?

Important conclusions from the research show that, mostly because of concerns regarding health risks, 17 of the 30 nations surveyed have prohibited the reprocessing of SUDs. The research made several recommendations to solve the problems and difficulties found:

  • Harmonized legislation: To provide a uniform approach to the reprocessing of SUDs, harmonized legislation and guidelines are being developed throughout the EU.
  • Strong Evidence Base: Carrying out additional research to establish a solid body of knowledge that clarifies the advantages and disadvantages of reprocessed SUDs for health.
  • Stakeholder interaction: To resolve issues and reach an agreement on the best methods for SUD reprocessing, it is important to increase stakeholder interaction.

Furthermore, a dashboard that offers a thorough summary of the study’s conclusions has been created to help visualize data and trends on SUD reprocessing in the EU. Informed decision-making and policy formation in the medical device industry are the objectives of this tool.