mdd

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...
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...
The medtech industry in Europe is made up almost uniquely of Small and Medium-sized Enterprises (SMEs). These have brought incredible innovations to patients, healthcare systems, the economy and society, and will continue to do so in the future. But if we put ever more data demands on these companies, in return, they need to be able to operate in a clear, efficient and predictable funding environment. Pop-quiz: What is the most innovative industry in Europe, measured by patents filed? It’s not the ICT industry. No, it’s not the pharma industry neither… It’s the medical technology industry, a sector that in general files over 10,000 patents per year. And it’s the SMEs that make up 95% of this sector in Europe that are the drivers of innovation. These deliver value at every level: Patients live longer, healthier lives Healthcare systems can use products that make more efficient use of limited resources European economies benefit from a brake on rising healthcare expenditure, while The medtech industry creates jobs (over 575,000 of them!) and growth (a positive trade balance of €15 billion). The medtech SMEs in Europe form a rich ecosystem that we cannot simply equate to the pharmaceutical sector, which in Europe is predominantly made up of multinationals and has product lifecycles of 10-15 years. At the same time, healthcare systems want more data and evidence of the value of innovations. The medtech industry, including SMEs, are committed to providing this data. However, while large multinational companies can easily move around (human) resources to cope with the additional work, this is much more difficult to do for companies that work with staff of between 1 and 250 people. Moreover, new legislation set to be introduced in a number of member states will considerably impact how innovations get reimbursed. Germany for instance has...
A 3D Printed Breakthrough for Complex Children’s Fractures from Materialise NV on Vimeo . Imagine that you break your arm and it heals back together incorrectly, making it difficult to perform simple, everyday tasks. Wouldn’t it be wonderful if your surgeon could use medical imaging data from your arm, make a 3D virtual model and test multiple approaches to figure out the best way to fix it? With 3D visualization software, this is possible. What about going one step further and your surgeon making surgical guides so he/she would know exactly where to cut and drill your bone, and use implants and plates designed to fit your unique anatomy? 3D Printing can make this happen. 3D Printing software and services have drastically grown over the past few years in the medical sector, particularly when it comes to surgical planning software and patient-specific medical devices. Patient-specific guides by Materialise More patients have benefited from 3D Printing software and solutions as more medical centers have adopted this technology. However, with this advancement comes the flipside, which is that regulatory bodies face the challenge to make this technology available while maintaining patient safety standards. This is why we advocate for dedicated regulation when it comes to medical devices so that it can continue to grow consistently and safely in the years to come. Regulatory Obstacles along the Road… This lack of regulation for 3D-printed, patient-specific medical devices can be seen in the current version of the EU’s regulatory framework. The EU has been working for many years on an update to the Medical Devices Directive. This proposed legislation has many noble attributes in addition to overcoming the flaws and gaps of the existing Medical Devices Directive, such as supporting technology and science innovation while simultaneously strengthening patient safety. This is something that we...