ivdd

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...
Last week, the European Parliament and the Council of the EU led by the Dutch Presidency came to an agreement on the medical devices and in vitro diagnostics regulations. To say the least, it has been a long process, and for the medical technology industry, we expect these regulations will have a significant impact on our products and services. Our industry needs this modern legislation. And I welcome the fact that the specific nature of medical technologies was considered during the legislative process. With over 500,000 medical technologies registered, it is important that these regulations take into account the diversity of our products and services while acknowledging our sector’s significant role and relevance in the healthcare continuum of patients. Importance of these new regulations to patients Medical technologies save lives, improve health and contribute to sustainable healthcare. These technologies are developed and produced for the welfare of patients. Despite the sweeping overhaul, many of the proposed updates in the regulations are welcomed by our industry as they will enhance patient safety and facilitate access to new technology for patients. I believe that the new regulations are critical in filling in the gaps of the existing laws and in bringing more harmonised set of guidelines across the region. Implementation will be key Now watch out, there’s still a lot to be done. Now, we are entering an even a more critical phase for the industry. After the lengthy legislative and political discussions, our regulatory focus will now shift towards the implementation process. And this is going to be more complicated. Once this agreement has been formalised, a set of legal process will take place including translation. From our side, we at MedTech Europe, Eucomed, and EDMA expect to work on a deeper analysis once we get a sight of the consolidated...
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...
Happy New Year! The year 2016 is set to be yet another eventful year for everyone. The world will be busy in 2016 with the Summer Olympics in Rio de Janeiro, and the European Football Championship across France. And we at MedTech Europe, EDMA and Eucomed are gearing for an exciting year ahead as well. I expect this year will continue to be busy as ever, with changes ahead of us - which I can assure you will impact the industry and the healthcare sector at large. At last December’s MedTech Forum and in front of the associations’ general assemblies, I presented our priorities next year for MedTechEurope, EDMA and Eucomed. And below, I listed our key priority areas in 2016: MD and IVD regulations: End of the road In 2015, the trilogue on the IVD and the medical regulation revisions started. While expectations that the trilogue would be finalised by end of last year, we knew that it would take more time due to the complexity and technical specificities of the two files. The trilogue will continue again this year, and with more provisions still waiting to be addressed, we expect the process to take more time and effort across the different stakeholders involved. We will remain an active contributor in safeguarding that this regulation upholds patient safety and welfare. Nevertheless, we will continue to ensure the industry is prepared and ready to make the adequate changes and investments to support the regulation. Value 2.0 The successful rollouts of our value initiatives in 2015 with the first ever MedTech Week and MedTech Discoveries, we are gearing up towards pushing these activities to the next level. The next MedTech Week in June 2016 will continue to bring members, partners and health stakeholders across Europe in promoting stories, facts and insights...
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...
Summer has ended and while most are just coming back from their holidays, I’ve been busy with the team in finalising our comments on the in-vitro diagnostic regulation proposal, which is finally moving towards the last phase in the legislative process. Council is close to landing their final positioning, enabling the trilogue discussions to begin between the Council, Commission and Parliament. Let me be clear - the industry wants this regulation to happen. But the uncertainty and lack of clarity from the recent council position will yield difficulties for everyone in the future. More attention to the IVD file is needed – and the lack of thorough considerations on the technical specifications applied will have a huge impact on the industry and in the end on patients. Details matter: the quality management system clause example Quality management systems are in place to ensure that products undergo a thorough check so the quality of the devices is maintained. However, the council position on the regulation did not take into consideration the specific needs of certain products like self-tests or near-patient tests. Most have been given more requirements that require additional yet unnecessary checks that do not go with the nature of the products themselves. The requirements should be feasible and applicable towards the nature of IVD tests and should be treated in detail separately. A requirement that might sound right for one device doesn’t mean that it makes sense to the other. Do we need more regulation? Don’t get me wrong, I welcome the fact that regulation is important. But adding too much can render more issues than benefits, for regulators, the industry and patients alike. A balance has to be made right between regulation and innovation. The discussions on clinical evidence and companion diagnostics are primary examples that make this...