Europe’s Regulatory Overhaul and the IVD Gap
The European Union is revising its medical-device rules to reduce compliance costs, simplify certification, and improve access to innovative technologies. However, in-vitro diagnostics (IVDs) risk receiving insufficient attention under the proposed reforms, raising concerns about whether the revised framework will address the sector’s specific challenges.
A 24 September 2026 report by Euractiv highlighted that only a fraction of Members of the European Parliament’s proposed amendments addressed IVD-specific issues. MedTech Europe has also called for changes that better reflect the scientific and regulatory requirements of diagnostic manufacturers.
The issue has significant healthcare implications. MedTech Europe estimates that diagnostic tests inform up to 70% of clinical decisions, supporting disease detection, treatment selection, and patient monitoring. Regulatory delays can affect both the availability of tests and investment in diagnostic innovation.
On 16 December 2025, the European Commission proposed amendments to the Medical Devices Regulation (MDR), Regulation (EU) 2017/745, and the In Vitro Diagnostic Medical Devices Regulation (IVDR), Regulation (EU) 2017/746. The proposal aims to reduce administrative burdens, improve certification predictability, and support innovation while maintaining patient safety.
The Commission estimates that the reforms could generate approximately €3.3 billion in annual savings, comprising €2.4 billion in administrative savings and €0.9 billion in adjustment-cost savings across the medical-device sector. These estimates cover the wider industry rather than IVD manufacturers alone.
Why In-Vitro Diagnostics Face Different Challenges
IVDs include tests, reagents, instruments, and software used to analyse human samples for disease detection, monitoring, and treatment decisions. They range from routine blood tests to advanced genetic testing and companion diagnostics that help determine whether a patient may benefit from a particular medicine.
IVD manufacturers must establish performance across three areas:
- Scientific validity: Whether the measured marker is associated with the clinical condition.
- Analytical performance: Whether the test accurately and reliably detects or measures its target.
- Clinical performance: How effectively the test identifies or predicts a clinically relevant condition in its intended population.
The IVDR became applicable on 26 May 2022, introducing a risk-based classification system covering four classes. The classification determines the level of regulatory scrutiny and the conformity assessment requirements applicable to a device.
| IVDR class | General risk level | Examples or characteristics |
| Class A | Lowest | Many general laboratory products and certain low-risk IVDs |
| Class B | Moderate | IVDs with moderate individual and public-health risks |
| Class C | Higher | Certain tests involving significant individual-health risks, including some genetic and cancer-related diagnostics |
| Class D | Highest | Tests associated with the highest individual and public-health risks, such as certain blood-donor screening tests |
Many IVDs require assessment by a notified body, increasing the importance of certification capacity, technical documentation, and performance evidence. These requirements can be particularly demanding for smaller manufacturers developing tests for rare diseases, emerging infections, or specialised patient populations.
To help manufacturers transition to the IVDR, the EU introduced extended deadlines for eligible legacy devices. Depending on the device classification and applicable conditions, these deadlines extend to December 2027, December 2028, or December 2029. The extensions provide additional time but do not remove the need to meet the regulation’s requirements.
The wider industry illustrates the economic stakes. The European medical-technology sector comprises more than 38,000 companies, approximately 90% of which are small and medium-sized enterprises (SMEs). It employs more than 930,000 people, and the European market was estimated at approximately €170 billion in 2024.
What the European Commission’s Proposed Reforms Could Change
The Commission’s proposal introduces measures intended to simplify conformity assessment, improve regulatory efficiency, and make requirements more proportionate to risk.
| Proposed change | Potential effect on IVD manufacturers |
| Simplified conformity assessment | Reduce unnecessary administrative work and make assessment more proportionate to device risk. |
| Certificate validity and oversight | Remove the general five-year maximum validity period for relevant certificates, replacing routine recertification with risk-proportionate oversight and periodic reviews. |
| Priority and rolling reviews | Support designated breakthrough and orphan devices, potentially improving access for tests addressing unmet medical needs. |
| Digital procedures and remote audits | Make regulatory interactions and documentation processes more efficient. |
| Support for SMEs | Reduce compliance burdens and help smaller developers manage regulatory requirements. |
| Improved coordination | Strengthen cooperation among the European Commission, national competent authorities, the European Medicines Agency, and notified bodies. |
These changes could improve planning and reduce repetitive administrative work. However, their impact will depend on the final legislation and its implementation. Faster administrative procedures alone may not resolve delays caused by limited notified-body capacity or the need to generate extensive performance evidence.
The proposals remain part of the legislative process and are not yet binding law.
Why IVD-Specific Changes Matter
MedTech Europe has argued that the reform needs to address the distinct challenges faced by diagnostic manufacturers, including requirements for performance studies and evidence generation.
IVDs differ from many other medical devices in how they are developed and validated. A test may depend on a specific biomarker, reagent combination, sample-preparation method, or analytical algorithm. Demonstrating its performance can require specialised studies and access to appropriate clinical samples.
These requirements become more complex as diagnostic technologies advance.
| Technology | Regulatory and evidence considerations |
| Polymerase chain reaction (PCR) | Tests detecting genetic material must demonstrate appropriate analytical sensitivity, specificity, and reliability. |
| Next-generation sequencing (NGS) | Sequencing-based diagnostics may require evidence supporting bioinformatics pipelines, variant interpretation, and clinical relevance. |
| Artificial intelligence-enabled diagnostics | Manufacturers must establish performance for the intended use and assess how algorithm changes affect validation and reliability. |
| Companion diagnostics | Tests linked to specific medicines may require coordination with pharmaceutical development, clinical trials, and treatment approvals. |
These examples show why reducing general administrative requirements may not be sufficient. Manufacturers also need clear expectations for performance studies, predictable assessment timelines, and requirements suited to specialised diagnostic products.
Implications for Diagnostic Companies and Innovation
The final rules could influence research investment, product launches, and competition across the European diagnostics market.
Companies such as Roche Diagnostics, Abbott, and Siemens Healthineers operate across diagnostic instruments, laboratory testing, and related technologies. Smaller developers often focus on specialised assays, novel biomarkers, or software-enabled diagnostics. Both established manufacturers and emerging innovators depend on predictable regulatory pathways.
For established companies, more efficient reviews could support product updates and portfolio planning. For smaller developers, lower compliance costs could free resources for research and development. Conversely, regulatory uncertainty or demanding evidence requirements could delay launches and make commercialisation more difficult, particularly for tests serving small patient populations.
The implications extend to pharmaceutical development. Companion diagnostics help identify patients who may benefit from targeted therapies, making their availability relevant to clinical-trial planning, treatment selection, and the commercial development of medicines.
Intellectual Property and Commercialisation Considerations
Regulatory reform also has implications for intellectual property (IP) strategy. Diagnostic innovations may involve patentable biomarkers, assay chemistry, reagents, sample-preparation methods, sequencing techniques, instruments, and software. The scope of protection depends on the invention and applicable patent law.
Companies must consider patent protection alongside regulatory requirements. A patent does not establish that a diagnostic meets the evidence and conformity requirements for market access. Regulatory uncertainty can affect launch forecasts, licensing negotiations, and investment decisions.
More predictable certification timelines could help developers plan commercialisation and negotiate partnerships with pharmaceutical companies, diagnostic manufacturers, and distributors. Smaller innovators may need to prioritise which inventions to patent, which markets to enter, and when to pursue licensing or co-development agreements.
A more efficient IVDR framework could improve investment conditions, provided it reduces unnecessary burdens without creating uncertainty around performance evidence or post-market responsibilities.
Can Europe Simplify Regulation Without Slowing Diagnostic Innovation?
The EU’s proposed reforms aim to make medical-device regulation more efficient while preserving patient protection. Measures addressing conformity assessment, certificate oversight, priority reviews, digital procedures, and support for smaller companies could benefit the sector.
However, IVDs need a regulatory framework that reflects their distinct scientific and clinical evidence requirements. Simplifying general procedures may have limited effect if manufacturers continue to face disproportionate costs, unclear requirements, or delays in performance assessment.
The Commission’s estimated €3.3 billion in annual savings indicates the potential scale of the reform, but it does not establish how much IVD manufacturers will save. The actual impact will depend on the final legislation and how the provisions are implemented.
For diagnostic companies, pharmaceutical developers, and investors, the central question is whether the revised framework can make market access more predictable while preserving reliable diagnostic evidence. That balance will help determine whether Europe can reduce regulatory friction without slowing innovation in the tests that guide clinical decisions.
Sources:
- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025PC1023
- https://health.ec.europa.eu/medical-devices-new-regulations/overview_en
- https://health.ec.europa.eu/medical-devices-vitro-diagnostics_en
- https://health.ec.europa.eu/medical-devices-vitro-diagnostics/transitional-provisions_en
- https://oeil.europarl.europa.eu/oeil/en/procedure-file?reference=2025%2F0404%28COD%29
- https://www.euractiv.com/news/in-vitro-devices-get-less-attention-in-eu-reform/
- https://www.medtecheurope.org/2026/05/05/medtech-europe-backs-eu-device-regulation-overhaul-but-asks-key-changes/
