European Commission Proposes Major Simplification of Medical Device Regulations

10 Feb 2026

Proposed reforms aim to cut costs, streamline compliance, and accelerate patient access to innovative medical technologies across the EU

The European Commission has unveiled long-anticipated proposals to simplify the European Union’s medical device (MDR) and in-vitro diagnostic (IVDR) regulatory frameworks. The revisions aim to reduce administrative burdens, improve coordination between regulatory authorities, and ensure patients gain faster access to safe and effective medical technologies particularly those designed for rare diseases.

Industry groups, including MedTech Europe, have broadly welcomed the proposals, calling them a necessary correction to regulatory systems that have struggled since MDR and IVDR came into force.

Why Change Is Needed

MDR and IVDR, which became applicable in 2021 and 2022 respectively, were designed to modernize a regulatory framework dating back to the 1990s. The goal was to improve patient safety and strengthen clinical evidence requirements following concerns about device performance and oversight.

However, implementation challenges quickly emerged. Manufacturers faced increased costs, regulatory uncertainty, and lengthy conformity assessment timelines. A shortage of designated notified bodies further exacerbated delays, contributing to supply disruptions and, in some cases, the withdrawal of devices from the EU market.

Recognizing these issues, the European Commission stated that the proposed revisions are intended to address “unnecessary costs, bottlenecks, uncertainty for companies, and delays for patients.”

Key Elements of the Proposal

The Commission estimates the revisions could deliver overall cost savings of approximately €3.3 billion per year. Among the most significant changes are:

• Simplified rules and clearer timelines for medical device conformity assessments, designed to speed up market access
• Stronger coordination across the EU, including an expanded role for the European Medicines Agency (EMA)
• Adjusted risk classifications for certain devices, such as reusable surgical instruments and accessories for implantable devices
• Exemptions for laboratory-developed tests when used exclusively in clinical trials

One notable proposal addresses medical devices incorporating artificial intelligence. Currently, such devices may be classified as high-risk under the EU AI Act. The revision would narrow the scope of the AI Act as it applies to medical devices, potentially reducing overlapping regulatory obligations.

Support for Orphan and Breakthrough Devices

The central focus of the proposal is improving access to devices intended for small patient populations. Transitioning from the previous regulatory framework to MDR and IVDR has led to the discontinuation of some devices used to treat rare conditions, largely due to the high cost of conformity assessments.

To address this, the Commission proposes new provisions for orphan devices, allowing certain products that were lawfully marketed under previous rules to remain available without undergoing a full conformity assessment, provided specific conditions are met. Notified bodies would also be encouraged to prioritize orphan and breakthrough devices.

MedTech Europe emphasized the importance of these measures, stating that dedicated pathways for breakthrough innovation and orphan devices are “critical for more rapid access to needed, safe and effective technologies.”

Industry Response and Remaining Concerns

While industry groups have praised the proposals, they have also highlighted areas for further improvement. MedTech Europe welcomed efforts to strengthen governance and system resources but noted that the proposal stopped short of creating a single, centralized governance structure. The group also urged lawmakers not to lose focus on long-needed amendments to IVDR, which are included in the same legislative package.

What Happens Next?

The legislative proposals will now be submitted to the European Parliament and the Council for consideration and adoption. Meanwhile, extended transition periods remain in place, allowing manufacturers until 2027 or 2028, depending on device risk class, to comply with MDR and IVDR requirements.

With the European Parliament already calling for reforms in 2024 and industry urging action by early 2026, momentum for change is clearly building.

Looking Ahead

If adopted, these revisions could mark a turning point for Europe’s medical device regulatory environment balancing patient safety with innovation, reducing regulatory friction, and helping ensure continued access to critical medical technologies across the EU.

For manufacturers, notified bodies, and healthcare providers alike, the coming months will be crucial in shaping how these reforms translate into practice.