The European Medicines Agency (EMA) published on 4 May 2026 the minutes of its Executive Steering Group on Shortages of Medical Devices (MDSSG) meeting held on 23 March 2026, detailing persistent shortages in categories such as in vitro diagnostics and implantable devices, and debating regulatory flexibilities to ease supply pressures while maintaining safety standards.
The MDSSG, established under Regulation (EU) 2022/123, coordinates prevention and mitigation of critical medical device shortages. During the 23 March meeting, members reported ongoing supply chain vulnerabilities and reviewed the effectiveness of existing measures, including voluntary stock redistribution and prioritisation of at-risk patients.
Policy orientations and trade-offs
The minutes reveal a tension between ensuring rapid device availability and upholding safety and performance standards. Members debated extending the validity of CE marks for certain devices to alleviate supply pressures—a move supported by industry but questioned by some national competent authorities concerned about quality assurance. The group also considered enhanced transparency requirements for manufacturers to report production disruptions, which could increase administrative burden but improve early warning capabilities.
Impact on stakeholders
Medical device manufacturers face potentially tighter reporting obligations and costs from accelerated recertification processes. Healthcare providers may benefit from more stable supply chains but face uncertainty during transition periods. National authorities gain better oversight but must allocate resources for monitoring. Patients stand to gain from reduced shortages, though some may face delays if quality checks are expedited.
Expected institutional follow-up
The MDSSG agreed to develop a list of critical medical devices by June 2026, with updated shortage prevention plans. The European Commission is expected to consider legislative proposals based on the group's recommendations, potentially amending the Medical Devices Regulation (MDR) to introduce permanent shortage management tools. The next MDSSG meeting is scheduled for September 2026.