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The Transformative Power of Artificial Intelligence in Healthcare Artificial Intelligence (AI) can change many industries, such as healthcare. It can help healthcare professionals with tasks, improve patient outcomes, and advance medical knowledge. When AI is used in medical devices and in vitro diagnostics, it must follow specific rules under the Medical Devices Regulation and the […]

Making primary use of health data and electronic health records work for citizens and patients A fundamental belief of the medical technology sector is that the great potential of emerging technologies must be harnessed through a patient-centred approach. The main objective is to deliver high-quality patient care and provide transparent information that builds trust between […]

Working for a company that is at the frontline of digital innovation in medical technologies, I believe that with continued advances in artificial intelligence (AI)-enabled medical devices, the possibility for improving patient lives can reach an entirely new level. AI in healthcare has the potential to solve pressing challenges for European healthcare systems. However, there […]

As lawyers we tend to use academic journals to tease out complex legal questions. (See our latest contribution to the literature here). However, today we’re taking the opportunity to discuss a hot topic with a broader audience, as we feel it will have a profound impact on the public, patients and health systems. That topic […]

The pandemic has changed many aspects of our lives. This is no different for those of us in the medtech space where we were pushed to rethink how we work. In the process, we learned how to find robust alternatives to important processes such as physical audits. These changes also revealed the need for greater […]

Policymakers spent years on agreeing on one of the most modern medtech rules in the world – this should not be undermined by revisions to horizontal legislation. As Brussels powers down for a short summer lull, I find myself in a reflective mode. The pandemic has transformed our lives – suffice to say that we […]

On 26th of May 2021 the EU Medical Device Regulation (MDR) became fully applicable. It is a modern piece of legislation that strives to ’establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation’. It further aims ’to ensure the smooth […]

After 4 years of transition period followed by a pandemic year, we reached the date of application of the medical device regulation 2017/745 on May 26, 2021. A lot of uncertainty is still associated with this date and key stakeholders are still questioning the readiness of the system. Twenty notified bodies out of fifty applicants […]

In 2017 the European Commission changed and updated the legal framework regarding the medical devices, superseding the existing directives, with two new regulations which added new responsibilities for European Medicines Agency and national regulatory authorities. The two new regulations, the MDR 2017/745 on medical devices and IVDR 2017/746 on in vitro diagnostic devices are scheduled […]