76 results
Posted on 08.11.2022
International trade in medical technology leaves the COVID-19 pandemic behind
COVID-19 dampened global trade in medical technology products. So, when we compiled the latest edition of MedTech Europe Facts & Figures (F&F), we knew readers would be keen to see whether the sector had rebounded. (Spoiler alert: it has!) F&F is the ‘go to’ guide to Europe’s medical technology sector. Packed with robust data drawn […]
Posted on 01.07.2022
Putting medical technologies at the heart of health innovation in Europe
From robotic surgery and wearables to connected devices and AI-powered diagnostics, medical technologies are reinventing healthcare. Europe’s medtech sector is making unprecedented investments in research & innovation – and joining the Innovative Healthcare Initiative for the first time. I sense that something big is happening in healthcare research. A tectonic shift in Europe’s health innovation […]
Posted on 27.07.2021
This is no time to further unsettle EU medtech legislation
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 […]
Posted on 17.03.2021
MedTech Slovenia: building the future together
The next chapter in the story of Slovenia’s medical technology industry has begun – and it is being co-written by leaders from the in-vitro diagnostics and medical devices sectors. SIEDMA and SLO-MED have formally merged to become MedTech Slovenia. Together, we are combining our expertise to speak for our diverse industry with one voice. […]
Posted on 26.11.2020
In vitro diagnostics at risk: Covid-19 delays progresses towards the new European 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 […]
Posted on 27.08.2020
COVID-19 & diagnostics: the value of ‘test, test, test’
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 […]
Posted on 15.11.2019
Prevention is better than cure: it’s time we value diagnostic information
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 […]
Posted on 19.08.2019
The increased role of Clinical Research Organizations in the context of the new EU regulations on medical devices
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 […]
Posted on 05.07.2019
Are you ready for Eudamed?
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 […]