57 results

Posted on 17.07.2023
Harnessing the Potential of Artificial Intelligence in Healthcare
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 […]

Posted on 22.05.2023
A European Health Data Space for a stronger Europe
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 […]

Posted on 31.03.2022
How strong data protection can help drive digital health
It’s hard to think of information that feels more personal than data about our own health. Yet we’re generating and monitoring more health data now than ever before. From specific technology designed to help manage certain medical conditions to home monitoring tools, there are more and more digital options to help manage patient health. The […]

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 26.05.2021
MDR enters into full application and challenges remain
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 […]

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 01.04.2020
5 ways innovation is changing orthopaedics
Innovation is the driving force behind the evolution of orthopaedics, continually delivering advances in surgical techniques and products. Now, technology improvements and data open up a world of new possibilities. Here are the top 5 areas where I believe innovation is transforming the field. 1. Co-creation: addressing unmet clinical, demographic and environmental needs We already […]

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 […]