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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 […]

The power of diagnostics information (VODI) to public health and society was a topic of keen interest even before the COVID-19 outbreak. The pandemic offers us fresh lessons on how health systems can harness this value.  Many of us will recall one of the earliest recommendation from the Director General of the WHO during the […]

Prevention is better than cure. It’s cheaper too. In fact, preventing future illnesses and preventing complications from existing conditions, are vital to the future sustainability of health systems.  For a vaccine that prevents measles, or a medication that prevents a heart attack, the value is obvious. But what about the value of learning that you […]

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 […]

We all know that the healthcare landscape is undergoing significant transformation. Today’s patients and clinicians are savvy consumers, demanding access to trusted product information to make informed decisions about health care. In parallel, government organisations are supporting patient safety through regulatory mandates around product traceability. To me, one of the biggest changes on the horizon […]

With the updated in vitro diagnostic medical devices (IVD) classification moving at least 80% of IVDs under Notified Body scrutiny (compared to 20% previously!), most manufacturers should now be gearing up to shift from self-certification to notified body oversight as we enter into the third year of the In Vitro Diagnostic Regulation’s transition period. A […]

The new EU regulations on medical devices and in vitro diagnostics (IVDs) share a laudable aim: They seek to modernise the regulatory framework and enhance transparency. The goal, shared by all stakeholders, is to enhance patient safety without harming innovations that improve patient outcomes. However, with these two regulations coming into force by May 2020 […]

New EU Regulations on medical devices and in vitro diagnostic medical devices (IVDs) mean all stakeholders, including manufacturers, competent authorities, and Notified Bodies – need new knowledge and skills. The Regulations seek to harmonise requirements, capacities and competencies of Notified Bodies and to me, one of the key advances is the new responsibilities for Notified […]

As I followed the 1,075 km cycling route starting at the Belgium coast and ending in Basel, Switzerland, along the Western Front line of the First World War, I began to consider the plight of soldiers and generals a century ago. For military leaders, it was impossible to have an overview of what was happening […]