The European Commission launched a public consultation and call for evidence as part of its targeted evaluation of the EU’s legislation on medical devices and in vitro diagnostic medical devices in 2024. The consultation was aimed to gather feedback from stakeholders on the effectiveness of the current regulations and identify potential areas for improvement.
The regulations governing medical devices and in vitro diagnostics are designed to ensure that only safe and effective products are available in the market, while fostering innovation and competitiveness within the industry.
The evaluation focused on several key aspects, including the effectiveness of the rules, their associated costs, and the administrative burden they impose. It also assessed the benefits for patients and users, as well as the impact on device availability, including “orphan devices,” and the development of innovative technologies.
Seizing the opportunity to shed light on the importance of circular practices for medical devices, DiCE experts submitted three key comments as part of the consultation:
- Insufficient Evidence - As outlined in the Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market, commissioned and published by the European Commission, decisions on whether reprocessing is allowed or not allowed are currently not evidence-based.
There is a need for further evidence and facts, particularly regarding safety, surveillance, economic and environmental impacts, and ethical considerations related to the reprocessing of single-use devices, taking into account the differences between reprocessing by healthcare institutions or manufacturers.
- Lack of Harmonisation – EU MDR states that reprocessing should be strictly controlled and allowed only for products where there is scientific evidence that such products can be reprocessed safely, including demonstration of cleaning, sterilisation, and relevant functionality. These regulations should be uniformly implemented across Member States. Reprocessing outside of these regulatory boundaries cannot guarantee the same level of patient safety and therefore should not be allowed.
Further, significant discussion can be triggered around the direct marking requirements for reprocessed devices. The EU requires direct marking regardless of the level of reprocessing, unlike the FDA, which bases it on the level of reprocessing/sterilisation.
- Unclear Reprocessing Criteria: Many products currently on the market, have not been designed with reprocessing in mind and therefore the materials and design may not withstand multiple uses. The Common Specifications of the MDR give some guidance on products which could be unsuitable for reprocessing, but there is still a need for further clarification on which types of devices are deemed suitable or unsuitable for reprocessing. Also, there are difficulties encountered with the different interpretations of “re-processed” and “single-use” vs. “single patient use.”
The Commission is currently reviewing the submitted comments (332 in total) and the amended rules should be adopted by the end of 2025.
