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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 […]

We all know that the healthcare landscape is undergoing significant transformation. Today’s patients and clinicians are savvy consumers, demanding access to trusted product information to make informed decisions about health care. In parallel, government organisations are supporting patient safety through regulatory mandates around product traceability. To me, one of the biggest changes on the horizon […]

With the updated in vitro diagnostic medical devices (IVD) classification moving at least 80% of IVDs under Notified Body scrutiny (compared to 20% previously!), most manufacturers should now be gearing up to shift from self-certification to notified body oversight as we enter into the third year of the In Vitro Diagnostic Regulation’s transition period. A […]

On May 25, 2018, the GDPR became effective across the EU, simultaneously resulting in a ‘consistent and homogenous application’ of data protection rules across the Union (per Recital 10 of the Regulation). For data protection professionals at medical technology companies, the clarity brought by the GDPR has meant that resources can be redirected towards ensuring […]

This year, GMTCC is fully part of the MedTech Forum. By joining forces to build synergies between the business and compliance communities, the industry is sending a clear message: compliance is part of the business! I have always been in favour of having the compliance officer seen as a true business partner. Indeed, compliance programmes […]

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 […]

By combining the GMTCC with the annual European MedTech Forum, the medtech industry is signalling that compliance is moving centre-stage, writes Nancy Travis, Vice President, International Compliance & Governance, AdvaMed For more than a decade, MedTech Europe and AdvaMed have jointly organised the key event on compliance professionals’ calendars. The Global MedTech Compliance Conference (GMTCC) […]

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 […]