Regulation

The EU medical technology regulations need a rethink to boost competitiveness that better safeguards patient access to innovation  Europe has a strong and diverse medical technology sector and some of the best health services in the world. However, a serious crisis is on the horizon, which threatens our shared progress. We must address this challenge […]

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 […]

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 […]

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 […]

Since January 2018 I am working for EUREGHA – European Regional and local health authorities– a Brussels-based association representing the interest at EU level of 15 regions coming from 10 countries across Europe. This vibrant network made me positively discover how local and regional health authorities are becoming more and more interested and engaged in […]