Survey Article 17 – Reprocessing of single-use devices

The document focuses on the implementation of Article 17, which regulates the reprocessing of single-use devices (SUDs) of Regulation (EU) 2017/745 concerning medical devices in the European Union (EU).

Implementation of Article 17 of Regulation (EU) 2017/745

The European Commission tasked a consortium led by the Austrian National Public Health Institute (Gesundheit ?sterreich GmbH), in collaboration with Civic Consulting, S&P Global and Areté to evaluate the implementation of Article 17 of Regulation (EU) 2017/745 on Medical Devices (MDR) regarding the reprocessing of Single-Use Devices (SUDs) in the EU. This regulation impacts reprocessing, which may only take place when permitted by national law. The study covers 30 countries, including EU Member States and other members of the European Economic Area (EEA), specifically focusing on the regulatory framework, certification, and practical challenges.

Key Background of Article 17

Article 17 of MDR:

Introduced new legal requirements for the reprocessing of SUDs, establishing that any natural or legal person who reprocesses a SUD must be considered its manufacturer and assume all related obligations. Health institutions reprocessing SUDs internally must comply with Common Specifications (CS). Reprocessing is subject to national regulations, and the Article allows countries to extend reprocessing permission or prohibition based on their laws.

Regulatory Implementation Across Europe

• 17 countries prohibit the reprocessing of SUDs (e.g., Austria, France, Norway).
• 10 countries allow reprocessing (e.g., Germany, Denmark, Sweden).
• ?3 countries (e.g., Portugal, Slovenia) have not yet made a decision.

National provisions for reprocessing exist in some countries, regulating either the practice or outright prohibiting it. A lack of standardized implementation contributes to a fragmented regulatory landscape.

Certification Process

The study found that of the 42 Notified Bodies (NBs) surveyed, only 6 certify reprocessed SUDs, citing reasons such as a lack of designation or low client demand. Despite some reprocessors operating, only a limited number of certificates have been issued for compliance with CS.

Challenges and Opportunities

Challenges:

• Safety concerns: Reprocessing may present potential health risks for patients. Stakeholders expressed uncertainty due to inconsistent data.
• Certification bottlenecks: Difficulty in identifying NBs capable of certifying reprocessed SUDs creates obstacles.
• Legal and ethical issues: Varying national laws create complexity and confusion in the implementation of Article 17 across borders.

Opportunities:

• ?Cost savings: Reprocessing SUDs can reduce healthcare costs.
• Environmental benefits: Stakeholders recognized that reprocessing could help reduce medical waste.

Stakeholder Actions and Recommendations

Stakeholders recommended several actions to optimize the reprocessing of SUDs such as:

• Regulatory clarity: Strengthen and standardize legal requirements to ensure all stakeholders are aligned.
• Training and risk management: Ensure health institutions and manufacturers are properly trained to manage risks and follow safety protocols.
• ?Tracking systems: Implement clear and consistent tracking of reprocessed devices to monitor outcomes and reduce risks.

There is a consensus that further scientific evidence is needed to address concerns and optimize the reprocessing of SUDs. Ongoing discussions in several countries could lead to legislative changes allowing the reprocessing of SUDs.

Conclusions and Recommendations

The fragmented regulatory landscape across Europe presents a significant challenge for the reprocessing of SUDs. Only 10 countries currently allow reprocessing, and certification processes remain limited. The report concluded that there is a need for further studies and clear guidelines at the EU level to standardize practices, reduce risks, and improve the overall process of reprocessing SUDs. Recommendations include developing further evidence-based research, increasing transparency in national regulations, and facilitating access to certification. This summary distills the main findings and suggestions from the report, covering its goals, challenges, regulatory insights, and future directions for implementing Article 17 MDR across the EU.