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IHI

Innovative Health Initiative launches first calls for proposals

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#DataForHealth

Health Data sharing brings essentials insights to solve the health problems of tomorrow

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Awareness campaign

Shining a Light on Medical Technologies

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COVID-19

COVID-19 MedTech Europe Information Hub

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Latest updates

News Innovative Health Initiative

Innovative Health Initiative launches first calls for proposals

Brussels, Belgium, 28 June 2022 – The Innovative Health Initiative (IHI) has launched its first calls for proposals, with topics on diseases such as cancer, cardiovascular disease and neurodegenerative diseases, as well as cross-cutting issues like health data and early-stage studies of medical devices.

Posted on 28.06.2022

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Resource library Digital Health

Data Act & amended rules on the legal protection of databases – the view from MedTech Europe

MedTech Europe welcomes the opportunity to provide feedback to the proposed Data Act and amended rules on the legal protection of databases, published on 23 February 2022. As indicated in our initial statement, MedTech Europe shares the Commission’s overarching objective to address barriers for the safe and secure sharing of data in the EU and leveraging the economic and societal potential of data. We call on EU legislators to support a data-driven economy that harnesses the power of data to advance and accelerate research and innovation in medical technologies and services for the benefit of European citizens, while preserving incentives for industry to invest in data innovation and protect citizens’ rights and interests. The medical technology industry is committed to doing its part by delivering medical devices that produce meaningful data available to healthcare professionals and patients to further improve patient outcomes whilst upholding the highest patient safety standards.

Posted on 13.05.2022

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Transition to EU IVD Regulation (EU) 2017/746 and considerations for non-EU regulatory authorities on managing the impact to product registrations

More than 31,000 in vitro diagnostic medical devices (IVDs) are expected to transition to the European Union’s (EU) in vitro diagnostic medical devices Regulation (IVDR) 2017/746 within the next years. Non-EU regulators will see changes to these devices’ regulatory documentation and labelling arising from the transition to EU IVDR. Because so many of these devices are transitioning around the same time, it is important for non-EU regulators to consider how to minimise disruption to the supply of IVDs in their country: In most cases, changes to regulatory documentation and labelling do not impact on the device’s safety and performance – it will be the same IVD medical test with updated information. A pragmatic approach may be needed for handling e.g. change notification applications or other national regulatory requirements. This document identifies considerations that can be shared with non-EU regulators on the recommended approach for handling changes deriving from the transition to the new EU regulatory framework. It builds on the experience gained so far with the transition as well as on a previous MedTech Europe’s publication which informed about the nature of the changes and their relevance for international registrations.

Posted on 13.05.2022

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Walking again after paralysis

“The first time that I stood up… it was like when you start a run. Now you are a starter for the challenge – the game has begun!”

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Predictive genomics: how Europe can tackle the barriers to better prevention

I believe technology is no longer the key barrier to unlocking the potential of predictive genomics.

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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

Interactions with the Medical Community

Interactions with the Medical Community

The medical technology industry is expected to find new ways to keep us healthy, and to do so 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).

Interactions with the Medical Community Picture

Brexit

Brexit

Brexit is a critical topic for the medical technology industry which has developed highly complex ties between the United Kingdom (UK) and the rest of the EU. Medical technologies are often moved between different EU countries during their production lifecycle and their clinical use. Crucially, up to 30% of our industry’s products have been authorised via UK Notified Bodies (CE marking) and could lose such authorisation overnight in the case of a “cliff edge” Brexit. MedTech Europe is tracking developments closely and has produced a position paper and other relevant documents to help medtech companies to navigate Brexit.

Brexit Picture

Access to Medical Technology

Access to Medical Technology

Medical technologies have the potential to save and improve lives, to inform citizens on the state of their health and to guide healthcare delivery.

Access to medical technology picture

New Medical Technology Regulations

New 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

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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Homecare & Community Care

Homecare & Community Care

The MedTech industry develops products that facilitate the delivery of health services in the community care setting and in people's homes. These technologies save lives, are convenient for patients and make efficient use of healthcare resources.

Homecare and community care

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

Market Data

Market Data

Information is power. Medical technology companies need to stay on top of the latest trends impacting their business. Informed decisions require up-to-date market intelligence from a trusted service.

Business stats displayed as graph and chart on a futuristic interface - Business concept

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. More and more of this data is now digitised; it can be stored and accessed on electronic health records and personal devices, shared among patients and healthcare professionals, and aggregated and processed with data advanced analytics
MedTech Europe works with policymakers and relevant stakeholders to realise the potential of data-driven healthcare. Together we focus on legal and regulatory issues (privacy, safety), technology (cybersecurity, interoperability), the business case (incentives, reimbursement), and emerging technologies (precision medicine, artificial intelligence).

Digital Picture

International

International

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

International Picture

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. EU 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 shared solutions to our common 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 MedTech 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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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.

Pathogen growth on selective media.

Cardiovascular

Cardiovascular

Cardiovascular diseases can impact millions of people of all ages. Diseases of the heart and circulatory system are the leading cause of death in Europe and a major cause of disability.

The medical technology industry provides high-quality solutions to the burden of cardiovascular diseases on individuals, families and the wider society. These innovations, which span the full spectrum of patient care from diagnosis to cure, save lives and add tremendous value to European 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 your bones, joints, ligaments, tendons, muscles, and nerves and allows you to move, work, and be active.

The MedTech 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 European society.

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Diabetes

Diabetes

1 in 11 adults around the world have diabetes. That’s about 60 million people across Europe, equivalent to the total Italian population. This number increases significantly every year. If current trends continue, diabetes will be the number one health threat in the coming years.

The European Diabetes Sector Group aims to reverse this trend by taking meaningful collective action to help avoid the diabetes pandemic where possible, and when diagnosis occurs to put people at the centre of care and give them back a full and fear-free life.

Diabetes Picture