NEWS | New Insight on the Implementation of MDR Article 17

Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation – MDR) regulates the reprocessing of single-use devices (SUDs) with relevance for the European Economic Area (EEA) which may only take place where permitted by national law and in accordance with this article.

Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation – MDR) regulates the reprocessing of single-use devices (SUDs) with relevance for the European Economic Area (EEA) which may only take place where permitted by national law and in accordance with this article.
April 12, 2024

The European Commission has unveiled a pivotal study on the implementation of Article 17 of Regulation (EU) 2017/745 (MDR), which governs the reprocessing of single-use devices (SUDs) within the EEA. This study evaluates how the provisions established in Article 17 MDR have been implemented and how such provisions function in practice.

Conducted across 30 European countries, the study offers a comprehensive analysis of the current market dynamics for SUDs reprocessing and reuse.

Key Highlights:

  • National decisions on SUDs reprocessing vary significantly -> 17 out of 30 countries indicated that reprocessing is not allowed.
  • Detailed examination of certification processes by notified bodies.
  • Insight into manufacturer and health institution practices regarding SUDs reprocessing.
  • Evaluation of health institutions’ reuse of purchased reprocessed SUDs.
  • Challenges, opportunities, and stakeholder-recommended actions are thoroughly discussed, culminating in strategic conclusions and recommendations to optimise the implementation of Article 17 MDR.

 

Read the full study here: IMPLEMENTATION OF ARTICLE 17 OF REGULATION (EU) 2017/745 (MDR) 

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