MedTech Europe Calls for Targeted MDR/IVDR Reforms to Restore Predictability and Competitiveness

MedTech Europe has published a new position paper on the ongoing revision of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), describing the current framework as “a regulatory system at a crossroads.”

The document supports the European Commission’s simplification proposal while also calling for targeted amendments to ensure the revised framework remains workable for manufacturers, notified bodies, and health systems.

The industry association argues that nearly a decade of MDR/IVDR implementation has exposed structural weaknesses, including lengthy conformity assessment timelines, inconsistent interpretation across Member States, and increasing administrative burden for manufacturers.

Focus on simplification

Among the measures strongly supported by MedTech Europe are:

• Open-ended certificates with periodic risk-based reviews instead of fixed five-year recertification cycles;

• Streamlined change control requirements;

• Risk-based sampling during conformity assessment;

• Broader recognition of clinical evidence, including modelling and simulation;

• Digitalisation of technical documentation and declarations of conformity;

• More proportionate requirements for near-patient IVD testing.

According to the paper, these changes could significantly reduce administrative bottlenecks without lowering safety requirements.

For manufacturers, one of the most relevant proposed changes concerns substantial changes and notified body approvals. MedTech Europe argues that only changes with a potential adverse impact on safety or performance should require prior notified body approval. Positive or neutral changes — including some cybersecurity updates or shelf-life extensions — could instead be reviewed during surveillance activities.

If adopted, this approach could improve regulatory agility and reduce delays in implementing product improvements.

Concerns around additional administrative burden

While supporting simplification overall, MedTech Europe also raises concerns about several proposed provisions that may unintentionally increase burden for manufacturers.

One example relates to the proposed requirement for notified bodies to validate UDI and registration data in EUDAMED. The association argues that manufacturers remain the legal data owners and that shifting validation responsibilities to notified bodies could create additional delays, higher costs, and new bottlenecks in market access.

The paper also opposes the proposal to include manufacturing sites on MDR and IVDR certificates, citing concerns around commercially sensitive information, administrative complexity, and export implications for international registrations.

AI integration and cybersecurity

The position paper strongly supports integrating AI requirements into the MDR and IVDR framework rather than creating parallel compliance routes under the AI Act.

MedTech Europe is calling for a time-bound process requiring the European Commission to adopt delegated acts within 12 months to align AI Act high-risk requirements with MDR and IVDR General Safety and Performance Requirements.

For manufacturers developing AI-enabled software or diagnostics, this could eventually lead to a more unified conformity assessment process and reduced duplication between regulatory frameworks.

Cybersecurity is another major focus area. The association proposes separating cybersecurity reporting obligations from traditional vigilance reporting within MDR and IVDR.

According to the paper, cybersecurity vulnerabilities that do not directly impact patient safety should follow dedicated cybersecurity processes rather than triggering MDR vigilance obligations. Manufacturers may welcome this clarification, particularly for connected devices and software-based products where vulnerability management timelines can differ significantly from safety incident reporting timelines.

Orphan and paediatric pathways

The document also supports the creation of dedicated breakthrough and orphan device pathways.

However, MedTech Europe argues that paediatric devices should be explicitly included in MDR Article 52a, even when they do not qualify as orphan or breakthrough technologies.

For IVDR, the association proposes aligning orphan device definitions with the existing EU rare disease threshold of 5 in 10,000 individuals instead of the proposed 1 in 12,000 annual prevalence threshold.

Manufacturers developing rare disease diagnostics may view this as particularly important for maintaining access pathways for niche products with limited patient populations.

Reprocessing of single-use devices remains controversial

One of the strongest criticisms in the paper concerns the proposed shift toward a “reusable by default” approach for single-use devices.

The Commission proposal would require manufacturers to justify why a device should remain designated as single-use. MedTech Europe argues this reverses long-standing regulatory principles and could create significant new obligations without clear safety benefits.

Instead, the association proposes maintaining a risk-based approach where single-use designation is supported through manufacturer risk management documentation.

This issue is likely to remain highly debated during the legislative process, particularly for manufacturers of consumables and infection-sensitive devices.

What this means for manufacturers

The MedTech Europe paper signals that the next phase of MDR and IVDR revision discussions will likely focus less on headline simplification and more on how the final legal text is implemented in practice.

For manufacturers, several themes stand out:

• Greater emphasis on risk-based oversight;

• Potential reduction of unnecessary notified body interactions;

• Increased focus on AI and cybersecurity integration;

• Ongoing pressure to maintain CE marking as the regulatory gold standard;

• Continued uncertainty around single-use device reprocessing obligations.

The paper also highlights a broader competitiveness concern: according to MedTech Europe, one in three manufacturers is already deprioritising the EU as a first-launch market due to regulatory complexity and unpredictability.

As the European Parliament and Council begin reviewing the Commission proposal, manufacturers should closely monitor how these amendments evolve — particularly those affecting change management, software classification, AI compliance, and post-market obligations.

Read the full document below.