Europe’s care in Europe’s control: secure continuity of care through medical device reprocessing under the Medical Device Regulation
Your family member’s surgery shouldn’t depend on an oil tanker getting through the Strait of Hormuz. And yet it does. Empty supply cabinets in operating theaters and nursing wards across the EU are an increasingly realistic threat as trade wars, disease outbreaks, natural disasters and armed conflicts break global supply chains. Every device that can be safely reprocessed is one less device that needs to be sourced through these fragile supply chains. Yet a large share of devices on the EU market is designated for single use under the Medical Device Regulation (MDR), which generally prevents reprocessing. Designing a device for single use is a choice, not a necessity. Devices reprocessed through appropriate and validated procedures are safe. The European Commission has proposed revising Article 17 of the MDR to require manufacturers to justify single-use designations. We strongly support this proposal.
The European Parliament’s Committee on Public Health (SANT) is currently working on its position on the MDR revision, including Article 17. The SANT Committee is expected to vote in early December, ahead of a plenary vote in the European Parliament that is tentatively scheduled for the 14th of December 2026. In parallel, the Council of the European Union, under the Irish Presidency, is developing its position with the aim of finalizing it by the end of 2026. Join our coalition and let them know what we want before they decide:
- Keep intact the European Commission’s requirement that a single-use designation of medical devices should be duly justified by manufacturers.
- Set the evidentiary standard for justification of this single-use designation by requiring manufacturers to provide objective and verifiable arguments that substantiate its necessity. This prevents a regulatory loophole whereby avoidable design choices themselves become sufficient justification.
Read our full statement here: Coalition Statement MDR
How can you help?
- Join the coalition with your organization. Please take a moment to fill out this short form: https://forms.cloud.microsoft/e/C6BdbtnrRU. With this information we will add your organization as a coalition partner on this webpage. Do you have a question or a suggestion? Feel free to contact coalition coordinator Thijs Elzer at l.elzer@lumc.nl.
- Share this statement in your network. As we regularly add new coalition partners, please share the link to this webpage rather than the PDF.
- Contact your country’s Ministry of Health. Urge them to champion our two asks in the ongoing negotiations in the Council of the European Union.
- Contact MEPs from your country. Urge them, both in the SANT Committee and in the wider European Parliament, to champion our two asks in the ongoing negotiations and upcoming plenary vote. An overview of all SANT Committee members, the Member States they represent, and their contact details is available at: https://www.europarl.europa.eu/committees/en/sant/home/members
