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In an era where transparency is expected, the healthcare industry has been at the centre of attention from the public and from authorities. We can see this in how governments around the world – notably the US and France – have developed ‘Sunshine Acts’ to mandate disclosure of industry support for healthcare institutions and professionals. […]

Healthcare is a complex system in which many actors and interests play a role. Unfortunately, the representation of some prevails over others, quite often even over patients’ interest, despite the fact that the whole system’s aim is to work for their well-being and safety. In mental health, in particular, industry and healthcare professionals have had […]

The new EU regulations on medical devices and in vitro diagnostics (IVDs) share a laudable aim: They seek to modernise the regulatory framework and enhance transparency. The goal, shared by all stakeholders, is to enhance patient safety without harming innovations that improve patient outcomes. However, with these two regulations coming into force by May 2020 […]

The new EU In Vitro Diagnostic Medical Devices Regulation (IVDR) was published in May 2017. While the IVDR has a five-year transition period (longer than the three-year transition for the EU Medical Devices Regulation), the procedures to designate Notified Bodies (NBs) under each of these two regulations have started at the same time. NBs are […]

As healthcare advocates, we know that dialogue between patients and the medical technology industry can deepen understanding between those who develop new healthcare solutions and those who use them. That is why our organisations, the European Patients’ Forum (EPF) and MedTech Europe, devised the Patient-Medtech Dialogue as a forum for regular interaction on topics of […]

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, Progress and […]

This blog is part 10 of a series on the MEAT value-based procurement project, an initiative that advocates towards a shift from price-based procurement towards value-based procurement. It does so by defining a Most Economically Advantageous Tendering (MEAT) framework that includes the value of medical technologies, services and solutions in procurement processes across Europe. Read part 1, part […]

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 […]

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 […]