88 results
Posted on 06.12.2021
How can we overcome barriers to homecare?
If the current COVID-19 pandemic has taught us anything, it is that critical hospital capacity can quickly become saturated in times of crisis. On several occasions over the past two years, this has led to delays in standard care to make room for extra capacity in intensive care units (ICU). However, we know that moving […]
Posted on 19.11.2021
EU move on mergers threatens innovation
At first sight, EU policy on mergers and acquisitions might not need to concern patients and frontline healthcare workers too much. However, a subtle shift in the rules on whether two companies can agree to become one could have a profound impact on access to medical innovation. To understand why this might be, it’s important […]
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 25.03.2021
New training video boosts global compliance – and public confidence
Bringing innovative medical technology to patients around the world is a priority for the medtech industry. This task often relies on a wide network of third-party intermediaries and distributors. While third parties provide valuable local knowledge, logistics and skills, it is important to appreciate that everyone working on behalf of medtech companies is bound by […]
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 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 15.07.2019
Medical technology and the new European institutions
Medical technology needs to communicate better about its value. Some people think it is the same as pharmaceutical healthcare. It is not. Medical technology has a different innovation approach, timeline and model. The European Union needs to communicate better about its value. Some people think it is the same as the national entities that make […]
Posted on 11.07.2019
Digital medtech: Rising to the GDPR opportunity
I believe that data has the power to transform patient care. But do the legal and regulatory landscapes in Europe and around the world pose some sort of obstacle to digital health innovation in the medical technology sector? This is a hot topic right now as patients – indeed, all citizens – become increasingly aware […]