regulations

In order to keep them available to the health care system and to patients, more than 85% of IVDs will need to be updated in view of the new in vitro Diagnostic Regulation (IVDR) which is at risk due to the ongoing COVID-19 pandemic. The remaining IVDR transition time is not sustainable and requires attention and effective solutions. An exponential increase in swabs and serological tests, a continuously evolving demand for quicker and accurate diagnosis as well as for tests monitoring respiratory functions and diagnosing complications are some examples of the high pressure that the IVD sector had to face and has been responding to since the beginning of the COVID-19 pandemic. IVD manufacturers have been on the frontlines of this fight, supporting Europe’s health services. They have invested in production, logistics, and expertise support to meet this challenge and have put research and innovation front and centre in order to define ways to identify the virus with increasingly effective methods. COVID-19 is monopolising the scene, increasing the already existing challenges for the sector in implementing the new IVDR. It has diverted the resources of companies, institutions, and all parties involved, with the result of slowing down implementation. The remaining transition time for the IVDR is no longer sustainable. The IVDR is scheduled to enter into full legal application from May 26 th , 2022 – in merely 18 months from today. The key elements of the regulatory system have been substantially upgraded, especially the requirements for clinical studies and post-marketing ones, the role of notified bodies, and a new risk classification system. However, the structural elements of the new regulatory framework have not yet been prepared. The guidance documents for new processes, such as on clinical evidence, are lacking. Expert panels and expert laboratories that are necessary to certify...
20 years ago, I'd have called you foolish if you suggested that the world's largest taxi company would not own any taxis. I'd have called you ill-advised if you suggested that the world's largest hotelier would not own any hotels. I'd have thought you unwise if you suggested that the world's largest book store could have centered its business model around not owning physical sales points. The world is changing, fast. The next sector in line for this wholescale disruption is healthcare. Regulation, high entry barriers and the sacred place healthcare holds in society have slowed the disruption. Now, it is gathering momentum. Robotics are entering the operating room with confidence1. New digital services are facilitating procedures for the healthcare community2. Virtual, AI assisted, consultations are becoming a reality with large scale deployment in London3. Digital reviews of doctors, which might someday evolve into public national rankings, are catching on in the US with questionable consequences4. Will we soon see healthcare primarily provided outside the hospital setting? Will our smartphone become our patient record? Will we go to our local 3D printer instead of pharmacies for personalised pills? None of these are as far away as we think. This changing landscape casts major questions for legacy players in the market: how should we react to forces that are disrupting and re-shaping our industry? The medical technology industry has major choices to make in the coming years that will shape our destiny. As I think through this, I increasingly believe a profoundly new vision is needed for medtech. I will be asking myself 3 big questions as we discuss amongst industry leaders in the coming months what such a direction might be: 1. Is the strategy bold enough? 2. Does it truly put people at the centre? 3. Will it protect...
New Medical Device Regulation – an obstacle to progress
On May 25 th , 2017, a new era began. The date marks the beginning of the Medical Device Regulation, the MDR in short. It provides a new framework for the certification of medical devices in Europe and is supposed to increase the transparency of the approval and application of medical devices, as well as to improve patient safety. New guidelines are challenging for all parties involved Patient safety is always of utmost priority; everybody agrees on this goal. However, with the new EU legal framework, we, in the medical technology industry, are faced with existential challenges: New clinical requirements as well as comprehensive documentation and reporting obligations will result in an increased bureaucracy. This also threatens to overstrain the notified bodies, which will be intensified through the decline in the total number of bodies and also through the loss of the British notified bodies in the course of Brexit. A lack of implementation regulations due to delayed detail regulations of the MDR significantly reduce the three-year transitional period for companies’ implementation. In my opinion, this represents a very critical situation for the medium-sized MedTech sector. But it is not just the medical technology companies that are affected by the current developments: Patients’ immediate access to modern procedures, devices, and examination methods will be made more difficult, and innovation will be delayed. Pragmatic solutions for a stronger culture of progress A development that I see as very critical, considering that our goal is to bring medical progress to patients more quickly. Meaning there is a stronger culture of progress in patient care through new technical solutions, a positive atmosphere for medical and technical progress, and a quicker transfer of research findings. To expedite this development and to protect and improve the health of people all around the world, we need...