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On May 25th, 2017, a new era began. The date marks the beginning of the Medical Device Regulation, the MDR in short. It provides a new framework for the certification of medical devices in Europe and is supposed to increase the transparency of the approval and application of medical devices, as well as to improve […]

One year has now passed since the ‘new’ EU IVD and medical devices regulations entered into force. Since Day 1, the medical technology industry has been working at full capacity to achieve and maintain maximum possible readiness.  While I’d love to claim the same for all other essential elements of the new regulatory system, progress […]

This blog is part of the GMTCC 2018 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com. Check out related blogs: Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global Stage, How to create and maintain an ethical culture, Global Responsibility, Global Ethics and Compliance, Global Principles for MedTech Innovation, Distributors […]

We are now over 15% of the transition period of the new European IVD Regulation (IVDR) and over 25% of the Medical Devices Regulation (MDR) transition. That said, transitioning to the new system comes with highly-ambitious timelines, and success will require great effort, by industry and authorities alike. Last week, at the Association of the […]

At long last, the date has arrived.  Organisations who aspire to be Notified Bodies under the European IVD and medical devices regulations can submit their applications as of yesterday, 26 November 2017.  In order for the new regulatory system to function as intended, it is essential that these assessment bodies be up-and-running as early as […]

As Germany goes to the polls, the VDGH, which represents in vitro diagnostics companies in Germany, has published a new policy paper on the future of healthcare. VDGH Managing Director Martin Walger tells Gary Finnegan why this is a crucial moment for health policy The paper was released just ahead of federal elections in Germany […]

According to the preliminary results of a study* aimed at the Finnish medical device industry, regulatory compliance pops up as the second biggest challenge burdening the industry. This, according to the study, comes in the wake of challenges for establishing effective international distributor channels. To me, this only verifies what I have experienced working in […]

MedTech Europe and IVDR & MDR training: a contribution There has been a lot of noise in the MedTech community on the recently adopted in vitro diagnostic medical devices regulation (IVDR) and the medical devices regulation (MDR). These new regulations were some 10 years in the making, yet many details still have to be clarified […]

Following on the footsteps of our American colleagues, MedTech Europe would like to offer some thoughts on the issue of transparency and disclosure laws and how certain adaptations could help to frame transparency for a new reality. Over the last few years, a number of European countries have passed transparency or disclosure (sometimes also called “Sunshine”) laws […]