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Open letter to Commissioner for Health, Stella Kyriakides: Need for comprehensive structural reforms of the medical technology regulatory frameworks
Together with 34 national associations, MedTech Europe has sent an open letter to Commissioner for Health, Stella Kyriakides, regarding the need for comprehensive structural reform in the European regulatory framework for medical technologies (IVDR and MDR). Representing the medical technology industry across all EU Member States and Switzerland, the 35 organisations emphasise the importance of a fit-for-purpose regulatory system which ensures that medical technologies can reach patients and healthcare systems across Europe in a timely manner. Despite more than six years of implementation, the medical technology regulations IVDR and MDR have not fully achieved their intended objectives. There are structural issues in the regulations which cannot be solved simply through their implementation, and which make them unpredictable, complex, and lacking in agile pathways for innovation. We acknowledge the considerable work which has been done by the European Commission and Medical Device Coordination Group (MDCG) to address the short-term implementation challenges. But reaching the objectives of the IVDR and MDR in full will require comprehensive change across the areas of efficiency, innovation, and governance – all while maintaining the highest standards of patient safety. We call for: An Efficient CE Marking System: We advocate for a more efficient and resource-effective CE marking system that improves predictability, reduces administrative burden, and adapts to external changes. Support for Innovation: We propose the inclusion of an innovation principle that swiftly connects the latest medical technologies to European patients and health systems through dedicated assessment pathways and early dialogues with developers. An Accountable Governance Structure: We suggest the establishment of a single, dedicated structure to oversee and manage the regulatory system, including the designation and oversight of Notified Bodies, with the authority to make system-level decisions. We ask the European Commission to elevate these pressing issues in relevant health policy debates and work with all medical technology stakeholders to jointly craft lasting solutions. Only together can we deliver on the original goals of the IVDR and MDR to develop an effective and fit-for-purpose regulatory system for the benefit of European patients, health systems and society. Read the full letter below.
Posted on 15.09.2023
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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.
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.
