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.

Liese noted that the proposed timetable requirement was blocked by Social Democrats, Liberals, and Green party members. He acknowledged that the MDR was well-intentioned and necessary after several scandals in which patients were harmed because there wasn't sufficient regulatory oversight, but he also added that the EU has "overshot the mark" in its efforts to correct the problem.

"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.

"It is good that the European Parliament voted by a large majority for targeted changes to be made as early as the first quarter of next year," he added. "Unfortunately, however, the Social Democrats, Liberals and Greens rejected the proposal to establish a clear timetable for the comprehensive revision that would tackle all the problems."

Liese said the EPP wants revisions to the regulations completed by the third quarter of 2025 and urged the European Commission to "massively accelerate" its process of revising the laws.

"There is no time to lose, and this must be an absolute priority," he added.

The European medical device lobby 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.

“Thus, MedTech Europe proposes immediate action to address the most pressing challenges and reduce bottlenecks: reducing and making predictable initial assessment timelines and costs, making assessments of changes to medical technologies more efficient, building an accelerated pathway for breakthrough innovation, and adapting certification timelines to follow a life-cycle approach,” said the group. “MedTech Europe also supports the Parliament’s call on the Commission to propose the systematic revision of all relevant articles of these regulations, accompanied by an impact assessment, to be conducted as soon as possible.”

“MedTech Europe welcomes the specific areas for attention which are called out in the Resolution, including its focus on bringing predictability, support for innovative and life-saving medical technologies, the support of [small and medium-sized enterprises (SMEs)] and eliminating unnecessary administrative burdens,” the group added. “In addition to these items, it is critical that a systematic revision of these regulations also include establishing a single, dedicated governance structure to oversee the regulatory system and ensure that it remains sustainable, efficient and delivers for patients.”

Besides asking for proposed revisions to MDR and IVDR by the first quarter of 2025, the resolution also asks the European Commission "to resolve issues of divergent interpretation and of practical application to streamline the regulatory process, improve transparency, and eliminate unnecessary administrative work for notified bodies and manufacturers, particularly SMEs, without compromising patient safety."

The resolution also calls on the Commission and member states to ensure that notified bodies have all the resources they need to implement the new regulatory framework and asked for more transparency around the fees and fee structures used by notified bodies. It also said the regulations should be updated to eliminate unnecessary recertifications and that certain products shouldn't be required to undergo the entire recertification process.

Joint resolution

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

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