Latest updates
MedTech Europe’s vision for cybersecurity in the medical technology ecosystem – position paper
The digital ecosystem has dramatically changed the way in which healthcare is delivered to patients. Nowadays, medical technology companies concentrate not only on ensuring the safety and security of MDs and IVDs, but also on the protection of patients’ and users’ confidential data. As such, medical device manufacturers invest substantial resources in guaranteeing state of the art cybersecurity for all their products and services, ensuring the resilience of the digital health ecosystem. In this position paper, MedTech Europe outlines three key areas of discussion for regulators, medical device manufacturers, healthcare systems and society-at-large. Firstly, that the security of medical technologies continues to be regulated under sectoral legislation. The Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation (‘MDR’ and ‘IVDR’) lay out essential requirements for digital medical technologies and services, including Medical Device Software (MDSW) placed on the EU market. In addition, MDCG 2019-16 rev.1 guidance on cybersecurity, provides medical technology manufacturers with the necessary guidance on fulfilling the relevant General Safety and Performance Requirements of MDR and IVDR respectively, with regards to cybersecurity. It also provides guidance on how to comply with both the Network and Information Security Directive (‘NIS1’), and the General Data Protection Regulation (‘GDPR’), both of which apply to medical technology manufacturers. Secondly, the paper underlines MedTech Europe’s commitment against ransomware, and other malicious interference with healthcare delivery in Europe. MedTech Europe welcomes legislative interventions aimed at reinforcing existing cybersecurity responsibilities and curbing tactics employed by potential cyber-attackers and cyber-criminals. The ongoing digital transformation of society and the lagging digitalisation of healthcare institutions and healthcare delivery continue to lead to healthcare being prime target for malign actors. MedTech Europe welcomed the revision of the Network and Information Security Directive (known as ‘NIS2’), as a means of reinforcing the digital resilience of states and businesses, while ensuring that they increase their investments in cybersecurity. While we welcome such legislative intervention, we believe that it should be combined with tangible investments in organisations’ security postures, resilience of digital tools and processes, and the investment in people and the skills necessary to deliver on such legislation. Finally, the paper highlights MedTech Europe’s support for measures aimed at improving the level of overall digital literacy, and particularly, cybersecurity skills. The evolving cybersecurity threat landscape coupled with a significant European cybersecurity skills shortage is an untenable situation, and must be addressed. MedTech Europe supports a public-private partnership approach to confront these issues. We also applaud the European Commission’s efforts to improve the situation, particularly through the European Skills Agenda Digital Education Action Plan, as well as the recently published communication for a Cybersecurity Skills Academy. Please find the full position paper below.
Posted on 23.05.2023
Small and Medium-sized Entreprises now Partners in Research at MedTech Europe
Posted on 06.04.2023
My family’s encounter with antimicrobial resistance
Pernilla Rönnholm, from Gothenburg, Sweden, shared the story of how antimicrobial resistance affected her family and her life.
Can IVD market sustain stellar growth?
Europe’s in vitro diagnostics (IVD) market has expanded sharply since 2020, with demand for SARS-CoV-2 tests driving double-digit growth for the past two years.
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.
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.
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.
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).
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.
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.
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.
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.
International
International
MedTech Europe engages with global agencies, decision-makers and stakeholders on key international issues facing medical technology companies.
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.
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.
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.
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.
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.
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.
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.
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.
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.
