1. Executive Summary

The EU medical technology framework is entering a new phase. After the difficult implementation of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), the European Commission has moved from emergency transition measures to a targeted simplification and competitiveness agenda.

The central question is no longer only whether the MDR/IVDR system can guarantee safety, but whether it can do so without delaying access to essential, innovative and biomedical technologies.

This eDossier covers the legal architecture, the latest simplification proposal, EUDAMED, notified-body bottlenecks, market data, the political debate and the biomedical dimension of medical devices. It also maps how MDR/IVDR now intersect with the European Health Data Space, the AI Act, the Cyber Resilience Act, Horizon Europe health research and the emerging EU biotechnology agenda.

Biomedical is used here in its policy-relevant EU sense: technologies at the intersection of medicine, biology, diagnostics, data and engineering. This includes technologies regulated directly as devices or IVDs, and technologies that support the development, validation, clinical evaluation, performance assessment, monitoring or market access of devices and IVDs.

Who should read this eDossier

• Manufacturers, authorised representatives, importers and distributors of medical devices and IVDs.
• Biomedical companies, laboratories, diagnostics developers, software and AI-medical-device teams.
• Hospitals, health systems, procurement teams and public authorities concerned by shortages, certification delays and patient access.
• Investors, SMEs, start-ups and policy teams tracking EU competitiveness, health innovation and regulatory simplification.

2. Introduction

In 2024, there was political pressure around the MDR/IVDR transition, certification bottlenecks, EUDAMED delays, SME costs and tensions between patient safety and market access.

Since then, the policy file has evolved in four important directions.

• First, the EU moved beyond one-off transitional extensions. Regulation (EU) 2023/607 and Regulation (EU) 2024/1860 gave additional time and enabled a more gradual EUDAMED roll-out, but the Commission is now proposing structural simplification rather than only deadline management.
• Second, EUDAMED has become an operational compliance issue. From 28 May 2026, the actor registration, UDI/device registration, notified bodies/certificates and market surveillance modules are mandatory.
• Third, the medical-device file has been inserted into a broader health-industrial competitiveness package, together with the proposed EU Biotech Act and the EU Cardiovascular Health Plan.
• Fourth, biomedical convergence has become unavoidable: diagnostics, implants, AI software, clinical data, electronic health records, cybersecurity and health-technology assessment increasingly interact with MDR/IVDR compliance.

3. What EUMED covers and why biomedical matters

EUMED should not be read as a narrow regulatory note on devices. It is a policy-intelligence dossier on the EU medical technology ecosystem. The core legal perimeter is MDR/IVDR, but the business and biomedical perimeter is wider: the dossier includes medical devices, IVDs, diagnostic platforms, medical software, AI-enabled decision-support tools, connected wearables, implantable devices, laboratory technologies, performance studies, clinical evidence, cybersecurity, health data and biomedical innovation programmes.

4. Core legal framework: MDR and IVDR

The core legal acts are Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The MDR replaced the former Medical Devices Directive and Active Implantable Medical Devices Directive, while the IVDR replaced the former IVD Directive. The aim is a high level of health protection, stronger clinical evidence, better traceability and more harmonised market surveillance across the Union.

4.1. MDR: main regulatory innovations

• Risk-based classification and more stringent scrutiny for high-risk devices.
• Expanded requirements for clinical evaluation, clinical investigations and post-market clinical follow-up.
• Unique Device Identification (UDI) and device registration obligations.
• Clearer obligations for manufacturers, authorised representatives, importers and distributors.
• Stronger post-market surveillance, vigilance, trend reporting and market surveillance coordination.
• Designation and monitoring of notified bodies under stricter requirements.

4.2. IVDR: the diagnostics transformation

The IVDR is not merely a technical update. It shifts the IVD sector from a largely manufacturer-self-declared regime to a risk-based system with much broader notified-body involvement. This is critical for biomedical innovation because diagnostics are increasingly linked to personalised medicine, genomic testing, companion diagnostics, data analytics and AI-assisted interpretation.

• Risk classes A to D, with highest scrutiny for Class D devices.
• Performance evaluation and performance studies as central evidence tools.
• EU reference laboratories and expert input for certain high-risk diagnostics.
• Specific requirements for companion diagnostics and genetic tests.
• Traceability through UDI and registration through EUDAMED.

5. EUDAMED, UDI and traceability

The European database on medical devices, EUDAMED, is designed to provide a living picture of device lifecycle information and to increase transparency for competent authorities, notified bodies, economic operators, healthcare professionals and the public. Commission Implementing Regulation (EU) 2021/2078 lays down detailed arrangements for setting up and maintaining the database.

6. The 2025-2026 simplification agenda

On 16 December 2025, the Commission presented a targeted revision proposal, COM(2025)1023, supported by the targeted evaluation SWD(2025)1051. The proposal should be read as part of a wider EU health package including medical-device simplification, the proposed EU Biotech Act and the Safe Hearts initiative. It seeks to reduce unnecessary administrative burden while preserving safety, performance and public-health safeguards.

6.1. What the proposal does not do

The proposal does not abolish the MDR/IVDR system. It does not remove the obligation to demonstrate safety and performance, nor does it eliminate notified-body scrutiny for high-risk technologies. Its logic is targeted: remove unnecessary friction, improve predictability and strengthen availability safeguards without lowering the baseline of patient protection.

7. Political debate and stakeholder positions

The political debate has converged around a shared diagnosis but not a single remedy. Parliament, Member States, the Commission, industry, SMEs, patient representatives, scientific societies and consumer organisations all recognise bottlenecks. The disagreement lies in how far simplification should go, how much discretion notified bodies should have, and how to prevent regulatory relief from becoming weaker protection.

7.1. BioMed Alliance: clinical and biomedical stakeholder input

The Biomedical Alliance in Europe (BioMed Alliance) is a European not-for-profit stakeholder organisation bringing together leading medical and research societies. It acts as a common voice for healthcare professionals and researchers in EU health policy and contributes clinical and scientific expertise to evidence-based policy-making. Its website presents the Alliance as representing 34 European medical and research societies and as a platform to improve biomedical research, training, mobility, policy representation and public understanding of medical science in Europe.

For EUMED, BioMed Alliance is particularly relevant because it works directly on the EU medical-device and IVD regulatory framework. Its Medical Devices workstream discusses the latest developments in the regulatory framework for medical devices, exchanges interpretations of the EU framework and identifies where clinical expertise can enhance medical-device safety in Europe. Its In Vitro Diagnostics workstream is relevant to the IVDR transition, in-house diagnostic devices, laboratory medicine, personalised care and the availability of essential diagnostic tools.

In the MDR/IVDR revision debate, BioMed Alliance supports meaningful simplification but stresses that simplification should not weaken patient safety, clinical evidence requirements or transparency. Its medical-device position highlights concerns about excessive administrative burden, reduced access to essential devices and diagnostics, the treatment of in-house IVDs, AI-enabled medical devices, orphan and breakthrough devices, expert-panel support, clinical-evidence transparency and the long-term monitoring of high-risk implantable devices.

Useful political sources include the EP Legislative Train file on medical devices, the EESC opinion on the targeted revision and the BioMed Alliance medical devices workstream.

8. EU governance and agencies map

9. Biomedical technologies, AI and software as medical device

Medical devices are increasingly biomedical systems rather than standalone products. A diagnostic product may combine a test, a digital interface, an algorithm and a data pipeline. A hospital device may be connected to cloud services. An implant may rely on software updates. These developments make MDR/IVDR compliance inseparable from AI governance, cybersecurity, interoperability, data quality and clinical validation.

9.1. AI-enabled medical devices

AI-enabled medical devices sit at the intersection of MDR/IVDR and the AI Act. In practice, developers must consider medical-device conformity assessment together with AI-system requirements on data governance, transparency, human oversight, technical documentation, post-market monitoring and risk management. MDCG guidance on the MDR/IVDR and AI Act interplay is therefore a key monitoring item for EUMED.

• Software may qualify as a medical device where it has a medical purpose such as diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
• AI diagnostic tools may also fall into IVDR-relevant workflows where they interpret or support diagnostic information.
• Cybersecurity is no longer peripheral: connected devices may also interact with the Cyber Resilience Act, NIS2-related expectations and sectoral security requirements.
• Clinical performance and real-world monitoring will become more important for adaptive or learning systems, even when the legal framework still relies on fixed conformity-assessment checkpoints.

9.2. Breakthrough and orphan devices

The EMA breakthrough medical devices pilot is relevant for biomedical innovation because it gives selected high-risk devices access to expert-panel scientific advice. According to EMA materials, the pilot focuses on devices that address unmet medical needs and can support the generation of evidence for technologies with high patient benefit but difficult development pathways.

10. Health data, EHDS, HTA and clinical evidence

The European Health Data Space Regulation is becoming strategically important for medical devices and biomedical technologies. It will affect interoperability, electronic health data access, secondary use of health data and the evidence environment in which devices are developed, monitored and assessed. The EHDS transition timeline also matters for real-world evidence, post-market surveillance and AI training/validation governance.

The HTA Regulation also matters for selected high-impact technologies, because the clinical evidence used for regulatory purposes and the evidence required for health-technology assessment may converge in practice, even though the legal functions remain different.

11. Market and statistical profile

The EU medical technology sector is economically significant and structurally fragmented. It combines large global players with a very large number of SMEs, specialised manufacturers and niche biomedical innovators. This explains why the MDR/IVDR debate has become a competitiveness debate: certification delays and compliance costs affect not only regulatory departments, but investment, product pipelines, market exits and patient access.

For sector statistics and market framing, see the Commission SWD(2025)1051 targeted evaluation and MedTech Europe Facts and Figures 2025.

12. Bottlenecks, risks and availability of critical devices

The most persistent EUMED bottleneck is not the absence of rules, but the capacity and predictability of the compliance system. Manufacturers report long timelines, repeated documentation questions, uneven interpretation, high fees and uncertainty around clinical evidence. Notified bodies face workload, designation and staffing constraints. Authorities face the problem of preserving safety while preventing market withdrawals, especially for orphan, paediatric, niche, low-volume and high-clinical-need devices.

13. Research, Innovation and EU Funding

13.1. Strategic relevance

Research and EU funding are no longer a secondary policy layer for the European medical devices sector. They have become one of the main instruments through which the European Union seeks to reconcile four objectives that are increasingly difficult to balance: patient safety, innovation, industrial competitiveness and strategic autonomy.

This is particularly relevant for medical devices, in vitro diagnostic medical devices, AI-enabled medical technologies and the broader biomedical ecosystem, where innovation depends not only on laboratory research, but also on clinical validation, regulatory science, health-data access, manufacturing capacity and market uptake.

The EU’s policy approach has progressively moved from a fragmented set of research grants towards a more integrated “health-industrial” agenda. Medical technologies are now linked to the European Health Union, the Life Sciences Strategy, the European Health Data Space, the AI Act, the MDR/IVDR framework, cybersecurity rules and the EU’s wider competitiveness agenda.

This means that EU funding should be read not only as financial support, but also as a policy signal: areas funded by the EU often indicate where future regulatory, industrial and market priorities are expected to concentrate.

The Commission’s Strategy for European Life Sciences, launched in July 2025, is particularly important for EUMED. It aims to position Europe as the world’s most attractive place for life sciences by 2030 and explicitly links biomedical innovation, health technologies, biotechnology, market access and public trust. The strategy is backed by more than EUR 10 billion annually from the current EU budget and, according to the Commission, has already mobilised EUR 793 million in 2026-2027 for research activities under the Health Work Programme, together with EUR 589 million from the Food, Bioeconomy, Natural Resources, Agriculture and Environment Work Programme.

13.2. Horizon Europe: the central research pillar

Horizon Europe remains the EU’s main programme for research and innovation. Following the mid-term revision of the Multiannual Financial Framework, its indicative funding amount for 2021-2027 is EUR 93.5 billion. For the EUMED sector, the most relevant part is Cluster 1 - Health, which supports research and innovation across health systems, disease prevention, digital health, personalised medicine, medical technologies and biomedical research.

The 2026-2027 Horizon Europe Health Work Programme is the final Health Cluster work programme under Horizon Europe 2021-2027. It is therefore particularly relevant because it represents the last major opportunity to use Horizon Europe to close gaps identified during the current programming cycle. The programme explicitly covers healthcare innovation frameworks other than pharmaceuticals, including medical devices, in vitro diagnostics, AI and substances of human origin.

For medical device and IVD manufacturers, Horizon Europe is most useful at the research, validation and pre-commercial stages. It can support collaborative projects on breakthrough technologies, digital and AI-enabled diagnostics, new biomaterials, biomedical engineering, clinical decision-support systems, health-data infrastructures, personalised medicine and new approach methodologies in biomedical research and regulatory testing. However, Horizon Europe is usually not a direct substitute for commercial financing: it is designed to support research and innovation activities, often through consortia, and not routine conformity assessment, ordinary product certification or standard commercial expansion.

For EUMED, the most strategic Horizon Europe angle is the link between research and regulatory readiness. Under the MDR and IVDR, innovative devices need stronger clinical evidence, post-market follow-up, performance evaluation and risk management. EU research projects that generate high-quality clinical data, interoperable datasets, real-world evidence and validated methodologies can therefore reduce the gap between invention and market access. This is especially important for SMEs, university spin-offs and biomedical start-ups, which often have strong technology but insufficient resources to move from prototype to certified, reimbursed and scalable product.

13.3. EU4Health: resilience, access and targeted health priorities

EU4Health is the EU’s dedicated health programme for 2021-2027. It was initially established with a EUR 5.3 billion budget, later reduced to EUR 4.4 billion after the revision of the 2021-2027 Multiannual Financial Framework. Unlike Horizon Europe, EU4Health is more policy-oriented: it supports health-system resilience, disease prevention, preparedness, access to health products, cross-border cooperation and implementation of EU health priorities.

For the medical devices sector, EU4Health is relevant because it addresses the availability and affordability of medical devices and crisis-relevant products, as well as the resilience of health systems. It can therefore support actions that are closer to deployment, access and system capacity than pure research. This is particularly important in areas where market incentives are weak but public-health needs are significant.

A clear example is the EU4Health action on orphan medical devices, in particular targeting paediatric patients. HaDEA published the EU4Health call EU4H-2026-SANTE-PJ-07 to promote the development of innovative orphan devices, with a focus on unmet medical needs in paediatrics. This is a policy-relevant signal: the EU recognises that the MDR/IVDR system, while strengthening safety and evidence standards, can create particular economic difficulties for low-volume, high-need devices. Targeted public funding is therefore increasingly used to keep essential innovation pathways viable where the market alone may not be sufficient.

13.4. Innovative Health Initiative and public-private biomedical partnerships

The Innovative Health Initiative Joint Undertaking is one of the main EU-level public-private instruments for health innovation. It succeeded the Innovative Medicines Initiative and has a broader scope that includes pharmaceuticals, medical technologies, diagnostics, digital health and cross-sector health innovation. The IHI model is particularly relevant for EUMED because many medical device and biomedical challenges require collaboration between industry, hospitals, research organisations, patient groups, regulators and data-infrastructure providers.

IHI calls increasingly reflect the convergence between medical technology, data, digital health and sustainability. For example, IHI Call 10 included topics on digital labelling of medical technologies, the European Health Data Space and PFAS in the healthcare sector. IHI Call 12 was launched in January 2026 as a single-stage, applicant-driven call aligned with the IHI Strategic Research and Innovation Agenda.

For medical device and IVD companies, IHI is particularly relevant where innovation requires system-level validation rather than isolated product development. Examples include digital instructions for use, interoperable product information, clinical data pipelines, real-world evidence models, AI-enabled diagnostics, sustainability of healthcare materials and cross-border health data reuse. These themes are directly connected to MDR/IVDR implementation, EUDAMED, the European Health Data Space and the increasing regulatory importance of lifecycle evidence.

13.5. Digital Europe, EHDS and health-data infrastructure

Digital infrastructure is becoming a precondition for biomedical and medical-device innovation. The Digital Europe Programme is the EU funding programme focused on bringing digital technology to businesses, citizens and public administrations. For EUMED, its importance lies in health-data spaces, AI deployment, cybersecurity, cloud infrastructures, testing facilities and digital public infrastructure.

The European Health Data Space Regulation, Regulation (EU) 2025/327, entered into force on 26 March 2025, opening a transition phase towards staged application. Its relevance for medical devices is substantial. It creates a framework for primary use of electronic health data and secondary use for research, innovation, policy-making and regulatory purposes. Over time, this should support better access to health data for clinical research, AI training and validation, post-market surveillance, performance evaluation and real-world evidence generation.

For AI-enabled medical devices and software as a medical device, the interaction between EHDS, MDR/IVDR and the AI Act will be central. The economic value of AI medical technologies depends on high-quality, representative and legally usable datasets. At the same time, the regulatory value of these datasets depends on their traceability, interoperability, governance and compliance with EU data-protection and health-data rules. EU funding under Digital Europe and related programmes can therefore become a strategic enabler for companies that need to validate algorithms, build data pipelines and deploy trustworthy AI in clinical environments.

13.6. EIC, EIT Health and scale-up finance

The European Innovation Council provides EU support for breakthrough technologies and high-risk innovation, especially through Pathfinder, Transition and Accelerator instruments. The 2026 EIC Work Programme opens funding opportunities worth more than EUR 1.4 billion for strategic technologies and scaling companies. Its 2026 framework includes life and health sciences, biotechnology and medical technologies among areas relevant for scaling deep-tech solutions.

The EIC is particularly relevant for medical device SMEs and start-ups that have moved beyond academic research but still face high technical, regulatory and market risk. For EUMED companies, this risk often arises from the combined cost of prototype development, clinical investigation, quality-management systems, notified-body interaction, reimbursement strategy, AI validation, cybersecurity and manufacturing scale-up. These are precisely the phases where private investors may hesitate because timelines are long and regulatory uncertainty is high.

EIT Health complements this ecosystem by focusing on innovation, entrepreneurship and market-oriented healthcare solutions. Its 2026 Innovation Validation Call supports projects with up to 50% of the total project budget and up to EUR 850,000 per project. For digital and AI-enabled medical technologies, EIT Health instruments can be relevant where companies need validation, clinical adoption pathways, commercial partners and investor readiness rather than fundamental research.

13.7. HERA, preparedness and medical countermeasures

HERA, the Health Emergency Preparedness and Response Authority, is relevant to EUMED because medical devices, diagnostics and biomedical technologies are part of the EU’s preparedness architecture. HERA’s mandate is to ensure that the EU and Member States are ready to act in the face of cross-border health threats. Its funding opportunities are connected to Horizon Europe, EU4Health, HERA Invest and rescEU, with a focus on medical countermeasures selected through intelligence gathering and threat analysis.

This is particularly relevant for diagnostics, rapid testing, surveillance tools, protective equipment, critical components, laboratory technologies, pathogen detection systems and scalable manufacturing. The COVID-19 experience showed that Europe’s dependence on fragmented supply chains can become a public-health vulnerability. For this reason, EU funding increasingly aims not only to invent new technologies, but also to secure supply, production capacity and rapid deployment in emergencies.

13.8. Industrial policy instruments: IPCEI, InvestEU and EIB support

Medical technology is also becoming part of EU industrial policy. In July 2025, the Commission approved the IPCEI Tech4Cure, an Important Project of Common European Interest in the health ecosystem. The project involves ten companies from five Member States and authorises up to EUR 403 million in public support, expected to mobilise an additional EUR 826 million in private investment. The Commission indicated that the projects concern innovative medical devices, including digital and AI features, and are expected to contribute to patient outcomes, healthcare efficiency and employment.

The IPCEI model is important because it moves beyond ordinary grants. It targets strategic projects with cross-border spillovers, high innovation content and significant market failures. In the EUMED context, this suggests that future EU industrial interventions may increasingly focus on critical medical technologies, advanced diagnostics, AI-enabled devices, strategic components, manufacturing capacity and technologies that strengthen Europe’s resilience.

The EIB Group and InvestEU are also relevant. InvestEU aims to support sustainable investment, innovation, social inclusion and job creation in Europe. In December 2025, the Commission and the EIB Group announced a new initiative intended to mobilise EUR 10 billion of investment for Europe’s biotech sector. While biotechnology is not identical to medical devices, the overlap is growing in areas such as diagnostics, biomaterials, biochips, lab-on-chip systems, tissue engineering, companion diagnostics and biomedical data platforms.

13.9. Cohesion policy and regional health innovation ecosystems

EU support for medical and biomedical innovation is not limited to centrally managed programmes. The European Regional Development Fund supports economic, social and territorial cohesion and, in the 2021-2027 period, enables investments in a smarter, greener, more connected and more social Europe. For EUMED, this matters because many medtech and biomedical ecosystems are regional: hospitals, universities, testing laboratories, incubators, manufacturing clusters, notified-body expertise and clinical networks are often concentrated in specific territories.

Regional programmes can support health innovation clusters, digital-health infrastructure, SME innovation, technology transfer, pilot lines, clinical-research facilities and skills. This is particularly relevant for Member States and regions seeking to build medtech capacity but lacking the density of established ecosystems found in Germany, France, the Netherlands, Belgium, Denmark, Sweden or Ireland.

13.10. Funding logic for EUMED stakeholders

For companies, research centres and public authorities, the EU funding landscape should be approached by innovation stage.

At early research stage, Horizon Europe, EIC Pathfinder and collaborative biomedical research partnerships are the most relevant instruments. At translational stage, Horizon Europe, IHI, EIC Transition and EIT Health can support validation, demonstrators and clinical evidence. At SME scale-up stage, EIC Accelerator, EIB instruments, InvestEU and selected national recovery or regional funds become more relevant. At system-deployment stage, EU4Health, Digital Europe, ERDF and public procurement instruments may support health-system adoption, data infrastructure and access to innovation.

For medical device and IVD manufacturers, the key practical point is that EU funding should be designed around the regulatory pathway from the beginning. A credible funding strategy should include MDR/IVDR classification, clinical evidence requirements, performance evaluation, quality management, notified-body capacity, EUDAMED data obligations, cybersecurity, AI Act obligations where relevant, reimbursement and post-market evidence. Projects that ignore these elements risk producing technically promising outputs that cannot be certified, adopted or reimbursed.

The EU funding landscape confirms the value of integrating medical devices into a broader EU Health Policy platform and positions health policy as a cross-cutting area covering public health, pharmaceuticals, medical devices, HTA, patient safety, digital health, preparedness and response. This is consistent with the direction of EU policy: medical devices are no longer treated as an isolated regulatory sector, but as part of a wider ecosystem involving industrial competitiveness, biomedical innovation, health data, AI, resilience and patient access.

The strategic message for EUMED readers is therefore clear. EU funding opportunities exist, but they are increasingly selective, policy-driven and linked to EU priorities. The strongest projects will be those that combine technological novelty with clinical value, regulatory readiness, data governance, European added value and credible market deployment. In this environment, the successful medical device or biomedical project is not simply a good invention: it is an innovation that can move through the full European pathway from research to evidence, certification, adoption, reimbursement and lifecycle surveillance.

14. Opportunities for industry and policy action

• Use the simplification proposal as a strategic compliance reset: map which products may benefit from reduced recertification or more proportionate surveillance.
• Treat EUDAMED as a data-governance project, not only a regulatory portal. Device master data, UDI records, certificates and economic-operator data must be clean and internally consistent.
• For AI-enabled or software devices, integrate MDR/IVDR, AI Act, cybersecurity and health-data governance from the design phase.
• For diagnostics and biomedical platforms, align IVDR performance evidence with clinical-use claims, health-data needs and possible HTA expectations.
• For SMEs, build an evidence and documentation calendar early. The policy direction is simplification, but high-risk devices will still require robust documentation and audit readiness.
• For public authorities and procurement teams, monitor critical-device availability and support early dialogue with manufacturers before market withdrawals become shortages.

15. Practical checklist

16. 2026-2028 watchlist

17. Legislative reference map

All key legislative references, EU institutional sources, agency pages and sector-statistics sources mentioned in this eDossier are listed below as active hyperlinks.