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Global Semiconductor Shortage Need for Prioritisation of Healthcare Capabilities
The ongoing global semiconductor shortage is severely impacting the manufacturing and assembly of medical technologies, i.e., medical devices and in vitro diagnostic (IVD). These industries combined use approximately 1% of the current global supply of semiconductors, and yet even this small amount is under threat of undersupply. The gap between supply and demand is likely to increase even further in the months and years ahead, as demand for medical technologies is expected to grow continuously. Ramping up medical technology supply to meet demand is essential, if healthcare systems are to clear the significant COVID-19 related patient backlogs that still persist in many Member States, while continuing to tackle the chronic challenges of ageing population and the resulting prevalence of chronic conditions and the aspiration for a digital transformation of healthcare that is desired in order to ease these pressures. It is therefore critical to ensure a continuous and sufficient supply of semiconductors, to meet the growing demand of healthcare systems for medical technologies needed to deliver patient care. Call for Action: Immediate global and European actions are needed to safeguard against harm to patients and healthcare systems stemming from the semiconductor shortage, including: (1) prioritized allocation of mature and advanced semiconductors to the healthcare sector, now and in the future (2) measures to allow for transparency in the allocation of semiconductors (3) flexibility to incorporate varying semiconductor types under the medical device and IVD regulatory frameworks in a swift manner (4) incentives to increase global production of various semiconductor types, and to facilitate efforts of end users to redesign medical technologies so they can use newer generations of semiconductors Read below the full paper.
Posted on 26.07.2022
MedTech Europe Survey Report – Analysing the availability of Medical Devices in 2022 in connection to the Medical Device Regulation (MDR) implementation
During the month of April 2022, MedTech Europe members participated to a survey commissioned by the Medical Device Coordination Group (MDCG) Task Force on Certification Capacity Monitoring to assess the availability of MDs in 2022 in connection to the Medical Device Regulation (MDR) implementation. As such, the MDCG drafted part of the questions included in the survey. MedTech Europe included additional questions with the aim to cover some areas that were not tackled by the MDCG questions. The responses by the companies that participated to the survey lead to the following conclusions: MDR certificates have not been issued yet for >85% of the >500,000 devices previously certified under the MDD or AIMDD 54% of survey respondents said that they do not intend to transition some of their portfolio to the MDR. All product categories are impacted by potential device discontinuations. Small and Medium Enterprises (SMEs) face more challenges in MDR implementation than larger companies. At least 15 % and up to 30% of SMEs still have no access to an MDR-designated Notified Body. For SMEs progress to MDR certification is slower than average. MDR is currently a disincentive against launching medical device innovation in the EU: approximately 50% of respondents are deprioritising the EU market (or will do so) as the geography of choice for first regulatory approval of their new devices.
Posted on 15.07.2022
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!”
Addressing new expectations for the future of health
The past few years have seen a seismic shift in the entire healthcare landscape.
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
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).
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.
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.
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.
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.
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.
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
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.
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).
International
International
MedTech Europe engages with global agencies, decision-makers and stakeholders on key international issues facing medical technology companies.
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.
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.
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 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.
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.
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.
