MedTech Europe MDR/IVDR 2.0 Position Paper: What the Industry Wants Changed in the EU's Regulatory Overhaul

What Just Happened

On May 5, 2026, MedTech Europe — the European trade association representing the medical technology industry — published a detailed position paper responding to the European Commission's proposed revision of the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). The document runs over 40 pages and provides specific legislative amendments organized into three categories: WELCOME (strongly supported), RETHINK (course correction needed), and STRENGTHEN (targeted improvements).

The position paper does not oppose the revision. MedTech Europe explicitly supports the Commission's direction on simplification, international cooperation, and innovation pathways. But it identifies significant gaps between the proposal's stated ambition and its actual legislative text — gaps that, if unaddressed, could reproduce the same implementation failures that have plagued MDR and IVDR since 2021.

This is not an academic exercise. The MDR/IVDR revision is the most consequential regulatory update since the original regulations were adopted in 2017. The European Parliament and Council are now reviewing the proposal, with a legislative timeline that could see adoption by 2028.

Background: Why the Revision Exists

Structural Problems with MDR/IVDR

The MDR (Regulation 2017/745) and IVDR (Regulation 2017/746) were designed to replace the outdated Medical Device Directives with a more robust framework. They delivered important improvements: stronger clinical evidence requirements, better post-market surveillance, and enhanced transparency through EUDAMED.

But the regulations also introduced significant unintended consequences:

• Notified Body bottlenecks — certification timelines stretched to 12–18 months or longer, creating backlogs that forced some manufacturers to exit the EU market entirely
• Reduced device availability — hundreds of device types disappeared from EU hospitals, particularly in niche and pediatric categories
• SME strain — small and medium enterprises bore disproportionate compliance costs relative to their revenue
• Innovation flight — the EU became the last major jurisdiction without dedicated breakthrough or orphan device pathways, pushing innovators toward the US (FDA Breakthrough Device Program) and Japan (PMDA SAKIGAKE)

In December 2025, the European Commission published its proposal to revise both regulations, aiming for a more proportionate, risk-based framework. MedTech Europe's May 2026 position paper is the industry's comprehensive response.

What MedTech Europe Supports (WELCOME)

1. Breakthrough and Orphan Device Pathways

MedTech Europe strongly welcomes the introduction of dedicated breakthrough (BtX) and orphan device pathways in the proposed revision. Europe is currently the last major regulatory jurisdiction without such pathways. The US has the FDA Breakthrough Device Program, Japan has the SAKIGAKE designation and conditional early approval system, and Australia has the TGA priority review pathway.

The proposal introduces new Articles 52a (MDR) and 48a (IVDR) that would create adaptive conformity assessment procedures for devices meeting breakthrough or orphan criteria. These include priority review, rolling submissions, and early engagement with expert panels and Notified Bodies.

However, MedTech Europe identifies two critical refinements needed:

2. Cybersecurity Reporting

The proposal includes explicit cybersecurity requirements in the General Safety and Performance Requirements (GSPR), requiring manufacturers to report actively exploited vulnerabilities and severe incidents to national CSIRTs and ENISA via EUDAMED.

MedTech Europe supports the direction but calls for proportionality in implementation. The concern is that overly broad reporting obligations — without clear thresholds for what constitutes a reportable event — could overwhelm both manufacturers and regulators with low-signal noise. The position paper asks for:

• Clear thresholds for reportable cybersecurity events
• Alignment with existing NIS2 and Cyber Resilience Act definitions
• Proportionate timelines that reflect the severity of different vulnerability classes

3. AI Integration into MDR/IVDR

The revision proposes that AI-enabled medical devices be primarily regulated under the MDR/IVDR conformity assessment pathway, with the EU AI Act's high-risk requirements not applying where MDR/IVDR already cover the same ground. This would avoid duplicative assessments.

MedTech Europe welcomes this direction but warns that implementation timelines must be realistic. The AI Act's compliance deadlines are approaching (2026–2027 for high-risk systems), and manufacturers need certainty about which requirements apply through which regulatory pathway — and when.

4. Digitalization (EUDAMED, UDI, e-Labeling)

The proposal pushes toward digital-by-default: broader use of EUDAMED, reinforced UDI requirements, and expanded e-labeling options. MedTech Europe supports these moves, noting that EUDAMED's mandatory activation on May 28, 2026, creates the infrastructure foundation these reforms need.

Specific supported elements include:

• Basic UDI-DI assignment before Notified Body submission
• More public UDI data
• Proportionality for small-volume and individualized devices
• Preferential conditions for SMEs

5. Simplified Rules for Health Institutions

The revision proposes more flexible rules for in-house devices manufactured by health institutions. MedTech Europe supports simplification here, but with a critical safeguard: CE-marking must remain the gold standard. In-house exemptions should be narrowly tailored so they do not undermine the regulatory framework for commercial devices.

What MedTech Europe Wants Changed (RETHINK)

1. Proportionality of Requirements

MedTech Europe argues that several proposed changes reduce regulatory scrutiny to levels below those that existed under the original Medical Device Directives — going too far in the name of simplification. Specific areas of concern include:

• Reduced QMS audit frequency — could weaken ongoing compliance verification
• Reduced technical documentation sampling — could allow deficient files to reach the market
• Reduced unannounced audit requirements — removes a critical deterrent against non-compliance
• Weakened vigilance data review — including SSCPs and PSURs
• Relaxed re-certification and expiry date requirements — could create gaps in oversight

Team-NB (the European association of Notified Bodies) published its own position paper in March 2026 echoing these concerns, noting that "reduced scrutiny may create short-term administrative relief but can undermine patient safety, weaken market trust and require substantially increased market surveillance resources from competent authorities."

2. Reuse of Single-Use Devices

The proposal places the burden on manufacturers to justify why a device cannot be reused. MedTech Europe argues this should be reversed: the indication should be based on risk management and the actual risks of reusing the device, not on a manufacturer's justification for single-use design.

3. Clinical Evidence Flexibility

MedTech Europe supports broader acceptance of non-clinical data (including in silico models and other New Approach Methodologies) for demonstrating safety and performance. The position paper also endorses flexibility to rely on published literature and the removal of the requirement for contractual access to technical documentation when claiming equivalence.

However, MedTech Europe cautions that the criteria for when non-clinical data is sufficient must be clear, predictable, and consistently applied across Notified Bodies.

4. IVDR-Specific Concerns

MedTech Europe emphasizes that the IVDR revision must not be overshadowed by the MDR revision. Key IVDR-specific issues include:

• Class C IVD transition deadline — the May 26, 2026 deadline for Class C IVD manufacturers to submit formal Notified Body applications is creating acute pressure
• Legacy IVD device workload — legacy devices still dominate the market, suggesting a heavy workload for Notified Bodies in the near future
• Diagnostics availability — without targeted IVDR amendments, Europe risks losing access to key diagnostic technologies for decades

What MedTech Europe Wants Strengthened (STRENGTHEN)

1. Governance and Single Accountability Structure

MedTech Europe identifies a significant missed opportunity: the proposal does not establish a single governance structure accountable for ensuring that the full range of safe and performing devices is available to patients in a timely way. Instead, governance remains fragmented across the European Commission, MDCG, competent authorities, expert panels, and Notified Bodies.

The position paper calls for a unified governance model that can resolve systemic issues (like Notified Body capacity) rather than treating them as individual national problems.

2. Notified Body Capacity and Predictability

The position paper explicitly links the success of the revision to Notified Body capacity. Even the best-designed regulatory pathway fails if there are not enough Notified Bodies to process applications in a timely manner. Key asks include:

• Uniform quality management and procedural requirements (addressed partly by Implementing Regulation 2026/977, adopted May 4, 2026)
• Structured dialogue pre- and post-submission
• Pre-agreed change control plans to reduce surprises during assessment
• Clear timelines for conformity assessment decisions

3. International Regulatory Cooperation

MedTech Europe strongly supports strengthening international cooperation through initiatives like the Medical Device Single Audit Program (MDSAP). The argument is straightforward: if a device has already undergone rigorous assessment by a trusted regulator (FDA, TGA, Health Canada, PMDA), the EU should be able to rely on that work rather than requiring a de novo assessment.

This is not about lowering standards. It is about avoiding redundant reviews that waste both regulatory and industry resources without improving patient safety.

4. SME Support

The revision includes fee reductions for micro and small enterprises, which MedTech Europe welcomes. But the position paper argues that financial support alone is insufficient. SMEs also need:

• Earlier scientific advice from expert panels
• Regulatory sandboxes for emerging technologies
• Simpler documentation requirements proportional to device risk

Comparison: MedTech Europe Position vs. Team-NB Position

Two major position papers have been published in response to the MDR/IVDR revision proposal. Their perspectives are complementary but not identical:

What This Means for Manufacturers

Immediate Actions

1. Track the legislative timeline — the European Parliament and Council are reviewing the proposal now. If adopted as planned, new requirements could take effect between 2028 and 2030
2. Prepare for EUDAMED — the mandatory activation on May 28, 2026, is the foundation for many of the revision's digital initiatives. Manufacturers who are not EUDAMED-ready will face compounding challenges
3. Assess breakthrough eligibility — the EMA's BtX pilot program opened for applications on April 28, 2026. Manufacturers with innovative devices should evaluate whether they qualify
4. Engage with Notified Bodies — structured dialogue and pre-agreed change control plans are coming. Early engagement positions manufacturers to benefit from these provisions

Strategic Considerations

• The revision favors proactive manufacturers. Companies that invest in EUDAMED readiness, digital labeling infrastructure, and early regulatory engagement will navigate the transition more smoothly
• IVDR remains a priority. Do not let the broader MDR revision distract from IVDR compliance obligations, especially the Class C transition deadline
• AI and cybersecurity requirements are converging. Start building integrated compliance frameworks that address MDR/IVDR, the AI Act, and NIS2/CRA simultaneously rather than treating each as a separate project

Key Takeaway

MedTech Europe's position paper is a constructive but firm response to the MDR/IVDR revision proposal. The core message is that the Commission's direction is right, but the legislative text needs targeted improvements to deliver on its promises. For manufacturers, the revision represents both an opportunity (simplified pathways, innovation support, international cooperation) and a risk (if implementation is rushed, under-resourced, or inconsistently applied).

The European Parliament and Council are expected to engage with these amendments throughout 2026 and 2027. The MedTech Forum 2026 in Stockholm (May 11–13) will be a key venue for stakeholder discussion.