EU Parliament passes resolution citing ‘urgent need’ for MDR/IVDR revision

The European Parliament has adopted a resolution to update the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) to avoid potential product shortages in the region, sketching out a timeline for when such changes will be proposed. The move comes as manufacturers have continued to voice concerns about the ability to meet deadlines to transition their products to the new regulations.

On 11 October, several lawmakers, led by German Member of European Parliament (MEP) Peter Liese with the European People’s Party Group (EPP), introduced a joint motion for a resolution to urgently revise the MDR and IVDR, parts of which were adopted by the European Parliament on 23 October. The adopted resolution calls on the European Commission to propose changes to regulations and to complete an impact assessment by the end of the first quarter of 2025. However, a request to detail a timetable to revise certain articles completely was rejected.

“The regulation, in its current form, is far too bureaucratic,” said Liese. “This is costing jobs and competitiveness—but most importantly, patients are suffering.” Liese, who is also a physician, said that many of his colleagues have reported that they are already unable to get certain medical devices and warned the situation could become worse. “There is no time to lose, and this must be an absolute priority,” he added.

The European medical device industry group, MedTech Europe, said it supports the resolution and also asked the European Commission to move quickly to make changes to the MDR and IVDR. In particular, it said the Commission should immediately focus on reversing the trend in the market that are preventing devices from getting to patients.

A copy of the Joint Resolution can be accessed from here. It is worth noting in particular the following extracts:

“[S]ignificant challenges have been encountered in implementing the MDR and the IVDR, not only leading to delays but also resulting in failures to achieve certification and approval of medical devices and in vitro diagnostic medical devices, particularly impacting small and medium-sized enterprises (SMEs), as well as resulting in shortages of medical devices and in vitro diagnostic medical devices, thus restricting patient access to innovative and life-saving therapeutic and diagnostic technologies”.

“[M]any stakeholders, in particular small and medium-sized manufacturers, notified bodies and healthcare providers, have reported difficulties in navigating the complex regulatory procedures under the current MDR and IVDR framework, with potential risks posed to the continuous availability of life-saving medical devices and critical in vitro diagnostic tests in the EU”.