Posted on 05.05.2026
MDR/IVDR revision: Building a simpler, more predictable framework for patient access and innovation
Europe’s regulatory framework for medical technologies is at a pivotal moment. Nearly a decade after adoption, the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) has revealed structural challenges: slow and unpredictable conformity assessment timelines, a high administrative burden, and divergent interpretations across Member States. These issues are affecting patient access to technologies, the availability of certain devices and diagnostics, and Europe’s attractiveness for investment. MedTech Europe welcomes the European Commission’s proposal as a strong basis for reform. The focus on simplification and international cooperation is particularly important. Moving towards risk-based oversight, streamlining procedures, and advancing digitalisation can reduce unnecessary complexity and allow authorities and notified bodies to focus on what matters most: where risks truly lie. Strengthening international cooperation through initiatives such as the Medical Device Single Audit Programme (MDSAP) is essential to increase the attractiveness of the EU market. At the same time, targeted improvements are needed to ensure the proposal delivers in practice. The proposed breakthrough and orphan device pathways require targeted refinements to reach their full potential. This includes explicitly covering paediatric devices under Article 52a MDR and aligning the IVDR orphan device definition with the EU rare disease threshold. The integration of artificial intelligence requirements into a single MDR/IVDR conformity assessment pathway should be accompanied by a clear and timely implementation process. Proportionate approaches are also needed in areas such as cybersecurity reporting and performance studies, to avoid unnecessary burden while maintaining robust safeguards. Finally, the proposed approach to the reprocessing of single-use devices should be reconsidered. Single-use devices are specifically designed for one-time use, and this is fundamental to their safety profile. The current proposal should be rebalanced so that reuse is assessed based on risk, with full manufacturer responsibilities clearly assigned to any entity refurbishing such devices. Ultimately, a simpler and more predictable system is not a shortcut on safety. It is the condition for safety, for timely patient access, and for Europe’s long-term competitiveness. With targeted refinements, the MDR/IVDR revision can deliver a framework that works better for patients, healthcare systems and innovation across Europe. Read our full position on the MDR and IVDR revision below.
Posted on 31.03.2026
White paper: Shaping the future of wound care in Europe
The MedTech Europe Wound Care Sector Group brings together national associations and leading industry partners to jointly elevate the visibility and priority of wound care across Europe. By uniting expertise from across the sector, the group works to highlight the significant, yet often overlooked burden that wounds place on patients, caregivers, and healthcare systems. Despite affecting approximately 7.4 million to 14.9 million people across Europe, chronic wounds continue to be under-recognised in policy and healthcare planning. The Sector Group aims to address this gap by fostering collaboration, sharing evidence, and driving policy dialogue that positions wound care as an essential component of resilient, equitable, and sustainable health systems. As part of this mission, the Wound Care Sector Group has developed a comprehensive White Paper that outlines the urgent need to make chronic wound care a healthcare priority. The document assesses the current challenges in prevention, diagnosis, treatment, and system-level coordination, and highlights how fragmented care pathways, insufficient training, and misaligned reimbursement structures contribute to delayed care and higher long-term costs. Through clear strategic recommendations (focusing on patient‑centred care, workforce capacity, policy alignment, innovation, and real‑world evidence) the White Paper provides a roadmap for coordinated European action. Its goal is to support policymakers, clinicians, payers, patient organisations, and industry in improving outcomes for millions of people living with or at risk of chronic wounds. Read the White Paper below.
Posted on 24.03.2026
MedTech Europe’s response to the public consultation on the Digital Omnibus
MedTech Europe welcomes the opportunity to comment on the Digital Simplification Package (Digital Omnibus), a timely initiative aimed at improving regulatory coherence and strengthening Europe’s digital competitiveness. Representing the medical technology sector, our members develop innovative medical devices, connected solutions, diagnostic software, and AI‑enabled technologies within a robust regulatory framework that safeguards patient safety, quality, and trust. Digital medical technologies are increasingly central to improving healthcare outcomes, enabling earlier diagnosis, more personalised care, and better clinical decision‑making. Ensuring that horizontal digital legislation is simplified and aligned is therefore essential—not only for compliance, but to allow innovation to translate efficiently into safe and effective technologies for patients and health systems. MedTech Europe supports the ambition to streamline EU digital legislation and emphasises the need for concrete measures that deliver real improvements in legal clarity, operational certainty, and regulatory alignment. Read our full response below.
About us
MedTech Europe is the European trade association representing the medical technology industries, from diagnosis to cure.
We represent Diagnostics and Medical Devices manufacturers operating in Europe. There are more than 2,000,000 products, services and solutions currently made available by the medical technology industry. These range from bandages, blood tests and hearing aids to cancer screening tests, pacemakers and glucose monitors.
Our sector employs more than 930,000 people. There are more than 38,000 medical technology companies in Europe, of which 90% are SMEs.
What we work on
ExploreSector Priorities
Interactions with the Medical Community
Interactions with the Medical Community
The medical technology industry is expected to act in a responsible manner. MedTech Europe and its members are committed to a high level of ethical business practices and have put in place strict guidelines to advise medical technology manufacturers on how to collaborate ethically with Healthcare Professionals (HCPs), Healthcare Organisations (HCOs) and Patient Organisations (POs).
Legal
Legal
In close collaboration with in-house counsels & privacy experts in member companies, MedTech Europe empowers its members to navigate the evolving legal landscape, ensuring they remain compliant while driving innovation in medical technology. On relevant topics, MedTech Europe also advocates for a balanced and predictable legal environment that ensures patient access to safe and innovative medical technologies.
Access to Medical Technology
Access to Medical Technology
Medical technologies have the potential to save and improve the quality of life, to inform people on the state of their health and to guide healthcare delivery.
Medical Technology Regulations
Medical Technology Regulations
Medical technologies are tightly regulated in the European Union. Before a medical technology can be legally placed on the EU market, a manufacturer must comply with the requirements of all applicable EU legislation and affix a CE mark to their device.
EU Regulations governing medical devices (MD) and in vitro diagnostic medical devices (IVD) were published in May 2017. MedTech Europe is working with our members and the authorities to support companies in complying with the legislation by the end of the extended transition periods.
Competitiveness
Competitiveness
European medical technology industry's vibrant research ecosystem contributes to innovation while fostering a resilient, competitive and future-ready Europe. Medical technology is one of Europe’s most dynamic, and innovative sectors, delivering world-class solutions for patients and health systems in Europe while supporting local economies.
Digital Health
Digital Health
Medical technologies are transforming the way healthcare works for all of us. From faster diagnoses to remote monitoring, digital health contributes to smarter, safer, and more connected care.
International
International
MedTech Europe engages with global agencies, decision-makers and stakeholders on key international issues facing medical technology companies.
Sustainability and Environment
Sustainability and Environment
In addition to the medical technology sector’s core goal of saving lives and improving health, environmental and social considerations are an integral part of our industry’s operations. We acknowledge that preserving a healthy environment and building socially responsible value chains are essential in keeping human beings in good health. Our industry needs to be at the forefront of addressing challenges related to sustainable healthcare.
Market Data
Market Data
Taking decisions based on individual knowledge and market understanding has proven to be insufficient in the digital era. Successful medical technology companies have leveraged the power of technology and big data to take rigorous decisions based on empirical data. Staying up to date with the latest trends requires a trusted data provider and market intelligence service.
Research and Innovation
Research and Innovation
Research & Innovation (R&I) is the lifeblood of Europe’s medical technology sector. Industry investment in R&I delivers life-enhancing devices, diagnostics, and digital solutions. The European Union’s support for R&I offers valuable opportunities for academia and industry to generate new knowledge and use it to tackle the biggest challenges facing our societies. The quest for tomorrow’s healthcare innovations demands new, broad partnerships. R&I is most impactful when it is based on collaboration. MedTech Europe is committed to working with others in the public and private sectors to find solutions to our challenges.
Innovative Health Initiative (IHI)
Innovative Health Initiative (IHI)
The Innovative Health Initiative (IHI) is a public-private partnership between the European Union and the European life science industries, under the EU R&I funding programme Horizon Europe. IHI was launched in 2021 and will run until 2027.
Sector Groups
Cancer
Cancer
Medical technologies play an essential role throughout the whole cancer continuum: they help prevent and detect cancer at early stages, treat patients and prevent treatment complications, as well as improve the quality of life of cancer patients and survivors.
Diabetes
Diabetes
Diabetes is a silent pandemic. There are 60 million people across Europe living with the condition—equivalent to the population of Italy – and the numbers are rising each year. If current trends continue, diabetes will soon be the number one health threat in Europe.
The MedTech Europe Diabetes Group aims to reverse this trend by taking meaningful collective action on prevention, diagnosis and treatment for the millions of people living with diabetes, so that they can get back to leading full and fear-free lives.
Antimicrobial Resistance (AMR) and Healthcare Associated Infections (HAIS)
Antimicrobial Resistance (AMR) and Healthcare Associated Infections (HAIS)
Antimicrobial Resistance (AMR) and Healthcare Associated Infections (HAI) are among the biggest global public health challenges of our time. These infections cause significant morbidity and mortality, put pressure on health systems, and incur rising direct and indirect costs.
Medical technologies can help to address these problems by preventing, detecting, monitoring and managing infections and resistance.
Cardiovascular
Cardiovascular
Cardiovascular diseases, including heart failure, atrial fibrillation-related stroke, heart valve disease or coronary heart disease, can impact people of all ages and remain the leading cause of death in the European Union.
The medical technology industry provides high-quality solutions to safeguard and promote cardiovascular health and reduce the burden of cardiovascular diseases on individuals, families, and the wider society.
Orthopaedic
Orthopaedic
Orthopaedics is the medical specialty that focuses on injuries and diseases of the human body's musculoskeletal system. This complex system includes bones; joints; ligaments; tendons; muscles; and nerves; and allows you to move, work, and stay active.
The medical technology industry develops products that reduce the burden of musculoskeletal diseases on individuals, families, and the wider economy. These innovations improve quality of life and add enormous value to the European society.
Wound Care
Wound Care
Wound care is the medical speciality focusing on preventing wounds from developing, identifying them early, and ensuring they heal effectively.
Medical technologies play a crucial role in transforming wound care, enabling earlier detection, more precise assessment, and advanced treatments that accelerate healing, prevent complications, and reduce the burden on patients and health systems.
A place for dialogue about medical technologies
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