ivdd

This blog is part of the Early Diagnosis campaign #BeFirst Early diagnosis and care can prevent illness from developing and slow disease progression. Lab tests, genetic tests, tests for chronic diseases and modern lab diagnostics can help facilitate earlier intervention and improves outcomes for patients and are increasingly valuable in informing treatment choice. Read the other blogs here: Why should we prevent cervical cancer? Because we can , A smarter way to fight colorectal cancer , Kidney Disease: catch it early to save lives and money , For kidney disease patients, treatment education and choice are key to better outcomes , Diagnosing severe hearing loss and deafness ****************************************** World Cancer Day (4 February) is an annual reminder of the heavy burden of cancer globally. We all know someone affected by this disease – a friend, a neighbour, a loved one. While outcomes are improving in many forms of the disease, the word ‘cancer’ still strikes fear in the hearts of those who hear it. Lung cancer is a case in point. The disease kills more Europeans than any other cancer. More than 250,000 citizens of the EU-28 die annually. [1] Lung cancer is often diagnosed late. [2] The impact of the disease can be curbed by diagnosing cases as early as possible – maximising the opportunity for successful surgery or treatment. 2 When diagnosed in the late stages of disease, the chances of being alive in five years’ time are not good: for those diagnosed with stage IV non-small cell lung cancer, the average five-year survival rates range from 2% to 13%. [3] The outlook is considerably better when diagnosed at stage I. Globally, most patients (58-73%) whose lung cancer is picked up in the earliest stage live longer than five years. 3 Reducing the burden Low-dose computed tomography (LDCT)...
One year has now passed since the ‘new’ EU IVD and medical devices regulations entered into force. Since Day 1, the medical technology industry has been working at full capacity to achieve and maintain maximum possible readiness. While I’d love to claim the same for all other essential elements of the new regulatory system, progress has so far been too slow and piecemeal. Let me repeat that: To the fullest extent possible, industry is ready, but the system is not. Time is running, and it’s running fast. Unless all essential elements of the new system are in place soon, time could very well run out. It could run out for our industry, for sure, but also for the hospitals, laboratories, patients and physicians who rely, every day, on life-saving and life-transforming medical technology products. Why, you ask? Surely the new EU regulations were designed to increase patient safety, better protect public health, and ensure both legal certainty and an innovation-friendly environment, right? Yes, those are the goals, but as we have been saying from the very beginning , these benefits can only be achieved if the necessary building blocks of the new regulatory system are in place early-on . Well, one-third of the transition period is now gone for medical devices. There is a little more time for IVDs, but on that front the work is even more daunting. Time running out to put the system in place Our regulators have been working as fast as they can, despite systemic resource constraints , it’s true that a few pieces of the system have started to emerge in the past 12 months. However, a huge amount is still outstanding, and is needed for manufacturers to fully comply by the dates of application. For instance, to date, we still have none of...
We are now over 15% of the transition period of the new European IVD Regulation (IVDR) and over 25% of the Medical Devices Regulation (MDR) transition. That said, transitioning to the new system comes with highly-ambitious timelines, and success will require great effort, by industry and authorities alike. Last week, at the Association of the European Self-Medication Industry’s (AESGP) regulatory conference, I presented MedTech Europe’s vision to the Heads of EU Medicines Agencies. In most Member States, these agencies are the home of our IVD and medical device competent authorities, meaning that the heads of these agencies bear ultimate responsibility for the successes (and failures) of our present regulatory journey. Building on MedTech Europe’s political messages for a successful IVDR and MDR implementation, our messages to the regulatory leaders are: 1) INVEST! The new Regulations are 2-3 times larger than the former Directives and they’re more detailed and burdensome, for business and for regulators. Good regulatory practice states that authorities need expertise and resources proportionate to the legislation they implement. After 50+ years of EU pharmaceutical legislation, most of our industry’s competent authorities sit in agencies with excellent pharmaceutical expertise. Several even have respectable medical devices’ expertise. Only a few have noteworthy IVD expertise and nearly none have ‘enough’ general expertise and (human) resources to properly implement the new Regulations. To their credit, several agencies are staffing up or would like to. Not many have received enough support – financial or political – from their leaders in the Ministries. Where support exists, it’s often challenging to find suitably trained people, especially in IVDs and emerging technologies. This needs to improve and quickly. Industry and Notified Bodies are already recruiting the best people they can find, and national authorities will struggle to compete in this well-tapped labour market. If staffing up...
As Germany goes to the polls, the VDGH, which represents in vitro diagnostics companies in Germany, has published a new policy paper on the future of healthcare. VDGH Managing Director Martin Walger tells Gary Finnegan why this is a crucial moment for health policy The paper was released just ahead of federal elections in Germany and seeks to highlight the value of laboratory diagnostics. Tackling major challenges such as access to laboratory innovations, pricing challenges and personalised medicines, the report also applies to other European markets. What practical steps can be taken to accelerate access to laboratory innovations? This is one of the most difficult tasks we have to tackle and there are no simple solutions. If assessment procedures take significantly longer than the IVD product lifecycle, industry will suffer. But do we persuade politicians and decision makers with that argument? We are asking for appropriate methods and decision procedures which are transparent. Are you concerned that prices do not match the quality/value of diagnostic products? Is the situation any worse for diagnostics than it is for devices, IT or medicines? The German market is faced with very low prices for most diagnostics services, and this is especially pronounced in clinical chemistry. A high market concentration among the medical laboratories makes this problem worse. In the long run, the innovation capabilities of our industry also depend on the level of remuneration. Can you give an example of how early diagnosis can improve outcomes for patients and deliver long-term value for the economy and society? As far as I can see, the benefits of early diagnosis to prevent colon cancer are the best documented. Germany will rearrange its early detection programme this year, introducing specific cancer screening tests called "iFOB-Tests" and regular invitations for statutory health insurance patients to participate. The...
It is important that the medical technology sector functions within a healthy ecosystem. Our sector needs an environment that is open, supportive and free from unnecessary bureaucracy in order to innovate and provide patients safe and effective solutions to their condition. Within the product lifecycle of a medical technology product, we work with patients, doctors, authorities and notified bodies to ensure that the product meets all the essential safety and performance requirements. Each group has a critical role to play, which in turn enables manufacturers to deliver to patients the medical technology products they need. What’s up? Notified bodies are the authority-controlled third-party, independent entities responsible for assessing whether a medical technology (device or a medical test) conforms to the relevant legislation in force. Over the last three years, however, we’ve noticed a significant decrease in the number of notified bodies. Some have been de-designated, had their scope restricted or voluntarily stepped down as a notified body in the field of medical technology. This decrease has meant fewer notified bodies are available to assess new products and renew certificates needed by companies to operate. At the same time, existing bodies are finding it difficult to find qualified personnel to help with the extra workload. The current situation with respect to notified bodies threatens the stability of the medical technology ecosystem. Without fully functioning notified bodies, our industry’s capacity to innovate is stifled. More importantly, it risks delaying or blocking patients’ access to needed medical technology. Because of these limitations, the approval process can take longer, subjecting products to considerable delays. In a time where product innovation is growing at a fast rate, we need a stable ecosystem of notified bodies that’s able to fulfil their roles and guarantee an efficient and timely service. And without this stable ecosystem, how can...
A month ago, the trilogue on the medical devices (MD) and in-vitro diagnostics (IVDs) regulation proposals have started.This discussion between the Council of the European Union, European Parliament and European Commission is one of the last steps of the process to land a consolidated text for the regulation. It’s almost the end of the road yet I can’t help but feel the underlying need to improve how the trilogue process is being organised so far. In the current three-way trilogue, I am concerned that the discussions on the IVD proposal are being overshadowed by topics on the medical device proposal. This concern is shared not only by the industry alone but also by several member states and officials from both the European Parliament and Commission. I’ve written in my last two blogposts the actions and consequences we needed to understand about the in-vitro diagnostics and medical devices proposals. While it may seem that these two medical technology sectors have a lot of similarities, it’s also important to note their striking differences. This is simply because, by nature and function, IVDs and medical devices are two different sectors with each having a distinct use, issues and applications. In reality, unlike other forms of medical technology, IVDs never interact directly with the human body. Their purpose is not to have a direct therapeutic effect, but rather to provide valuable information on a patient's health status. The value of IVDs comes from the information they provide. This means that the expertise of the healthcare professional in using an IVD is crucial to ensure the correct decision making for patient treatment and care. This sets IVDs apart from medical devices and pharmaceuticals, and is part of what makes them unique amongst health technologies. Given this reality, the requirements that will be put in place...