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MedTech ON AIR

The Lifeblood of Europe’s Medical Technology Sector: Collaborative Research and Innovation with Guest Mark Lloyd Davies

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The Innovative Health Initiative (IHI)

Health Innovators, are you ready? Innovative Health Initiative launches Calls for Proposals #6 and #7  

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The MedTech Forum

Registrations for the MedTech Forum 2024 are open!

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European Union

MedTech Europe Manifesto for 2024 – 2029 | Empowering Patients, Inspiring Innovation

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Connecting the Dots

Wacth season 2 of 'Connecting the Dots'!

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Market Data

Check out the Facts & Figures 2023 report!

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MedTech Europe Code of Ethical Business Practice

R&I

Interested in finding out how your medical technology company can participate in the Innovative Health Initiative (IHI)?

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R&I

Start-ups & Small and Medium-sized Enterprises (SMEs) can now apply as Partners in Research

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Latest updates

Resource library AI Digital Health

Medical technology industry perspective on the final AI Act

In response to the European Parliament Plenary endorsement of the AI Act, MedTech Europe would like to present a medical technology industry perspective on the final agreed text of the AI Act. We welcome the significant efforts made by the co-legislators to reduce unnecessary administrative complexities and legal uncertainties arising from the simultaneous application of multiple Union Harmonisation Legislation and encourage consistency across the relevant applicable rules for the medical technology sector. However, further clarity is still needed to ensure that the AI Act supports European technological innovation, and the wider integration of AI within and across European healthcare settings, ensuring timely delivery of trustworthy, safe and effective care and diagnosis, for the benefit of patients and healthcare systems. Read more below.

Posted on 13.03.2024

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MedTech Europe views on the ‘One Substance, One Assessment’ European Commission package of legislative proposals

MedTech Europe published its views and recommendations on the ‘One Substance, One Assessment’ (OSOA) package of legislative proposals published on 7 December 2023. The concept behind the OSOA package to streamline the assessment of chemicals across EU legislation is welcomed as a means to bring efficiency and a harmonised approach to chemical assessments and processes. Some potential benefits include reduced animal testing and the prevention of duplicate testing and regulatory activities. Furthermore, ECHA’s involvement in RoHS could lead to more transparency, predictability, and legal certainty in the exemption process for businesses. The medical technology industry finds it important to have opportunities in the long-term to continue shaping the OSOA approach and the three legislative proposals that implement it. We consider that several clarifications are needed to optimise the legislative proposals in the OSOA package, including the following: Ensuring ECHA has the necessary expertise at hand to handle the new responsibilities envisaged in the targeted amendments to RoHS and the Medical Devices Regulation (MDR), i.e. in specific technologies (electronics, medical devices and IVDs) and their respective legislation (medical devices and IVDs in the scope of RoHS are regulated by sectoral legislation MDR and IVDR). Ensuring that a formal Impact Assessment is carried out, considering the additional resources and budget needed for ECHA to deliver on its new tasks. Providing ECHA with the necessary funding via the ECHA Founding Regulation, to ensure it is empowered to complete its (new) tasks. The reallocation of tasks to an already overburdened ECHA and its Committees raises concerns about resource efficiency, effectiveness and accuracy of evaluation outcomes. Using the OSOA package and specifically the common data platform as an opportunity to streamline existing databases and regulatory requirements for business operators and remove any such duplication of existing information requirements. Clarifying the interface between REACH and RoHS, considering the new role of ECHA, e.g. preventing regulatory overlaps. A common data platform seems to be an improvement in principle; however, more details need to be provided as to what information will be made available in the public domain and how confidential business information will be protected. Read the full position paper below

Posted on 14.03.2024

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Uniting for change on Rare Disease Day

It’s been a long but rewarding journey for Iuliana Dumitriu, whose 9-year-old son Victor has a rare genetic disorder called Coffin-Lowry syndrome. Now she’s helping other families by connecting them and raising awareness around the world.

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Empowering patients will boost the quality of healthcare

Across Europe, campaigning is underway ahead of June’s European Parliament elections. This marks the beginning of a new chapter in the cycle of EU decision-making and offers us all a moment to take stock.

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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 500,000 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 730,000 people. There are more than 32,000 medical technology companies in Europe, of which 95% are SMEs.

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What we work on

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.

New EU Regulations governing medical devices (MD) and in vitro diagnostic (IVD) were published in May 2017. MedTech Europe is working with our members and the authorities to support companies in complying with the new legislation by the end of the transition periods – 2021 for MDs and 2022 for IVDs.

The European Neighbourhood

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.

Access to medical technology picture

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).

Interactions with the Medical Community Picture

COVID-19 Information Hub

COVID-19 Information Hub

As the spread of the coronavirus COVID-19 continues to impact the health of people and the economy of countries around the world, the medical technology industry is working to support all ongoing efforts against this pandemic.

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Privacy, Liability and Collective Redress

Privacy, Liability and Collective Redress

MedTech Europe engages with members and EU stakeholders on key topics such as privacy, liability and collective redress. The reason for this engagement stems from the fact that medical technology companies doing business in Europe are subject to a host of legislation they comply with.

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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.

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Environmental and Social Sustainability

Environmental and Social Sustainability

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.

Environmental sustainability picture

Digital Health

Digital Health

Medical technologies generate information and data that are critical for the prevention, diagnosis, treatment, monitoring and management of health and lifestyle. This data can be stored and accessed on electronic health records and personal devices, shared among patients and healthcare professionals, aggregated and processed with advanced data analytics.

Digital Picture

International

International

MedTech Europe engages with global agencies, decision-makers and stakeholders on key international issues facing medical technology companies.

International Picture

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.

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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.

Research and Innovation

Ophthalmology

Ophthalmology

Vision loss can have a profound impact on those affected, resulting in lost independence and significantly limiting daily activities. Ageing increases the risk of eye diseases that can lead to visual impairment. The medical technology industry develops products that reduce the burden of eye disease on individuals, families and the wider economy. These innovations add enormous value to European society.

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Homecare & Community Care

Homecare & Community Care

The medical technology sector develops products, services and solutions aimed at delivering care in the community setting and in people's homes. These technologies are convenient for patients, improve their quality of life and can save lives, while being an efficient use of healthcare resources.

Homecare and community care

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.

Cardiovascular Picture

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.

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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.

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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.

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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.

Diabetes Picture