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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 […]

The Advamed Latin America Compliance Conference and the upcoming Global MedTech Compliance Conference  Sometimes I feel that compliance is like a jigsaw puzzle where every new piece brings us closer to the complete picture: Codes of Ethics. After being heavily involved in the adoption of the MedTech Europe Code of Business Ethical Practice, during my […]

I recently sat down with Peter Blenkinsop, a Partner at DrinkerBiddle, an expert on data privacy and one of the panelists at our upcoming GMTCC Conference (Amsterdam, May 3-4), to get his take on the biggest privacy law challenges currently facing Medtech companies. Peter pointed to two trends that are changing the Medtech sector and provided insight on how privacy […]

Each fall the two of us meet to discuss global healthcare legal and compliance developments and to assess implications on the medical technology industry, patient care and innovation. When we first began collaborating the iPhone was just invented (healthcare apps were unimaginable) and, since that time, quite a bit has changed! When we annually meet, […]

As a medtech lawyer, my focus naturally gravitates to assessing “downstream” relationships and risk; that is, analysis of the legal arrangements between manufacturers, distribution agents, and health care providers that together bring medical technologies to the patient’s bedside. These relationships can be complex, as are the legal issues they raise. But ensuring ethical standards in these relationships […]

The MedTech Europe Code of Ethical Business Practice entered into force on the 1st January 2017, with the phase-out of direct sponsorship that needs to be implemented in less than a year from now. The Code has been the topic of many conversations. However, until recently, we did not have the opinion of individual Healthcare […]

The new MedTech Europe Code of Ethical Business Practice (the “Code”) came in force on the 1st January 2017 and replaces the Eucomed Code of Ethical Business Practices and the EDMA Code of Ethics. The Code allows for an additional year to phase out direct sponsorship by the entire medtech industry but this may be […]

“All men make mistakes, but a good man yields when he knows his course is wrong, and repairs the evil. The only crime is pride.”— Sophocles, Antigone Just two decades ago, in the late ‘90s, the Institute of Medicine presented shocking statistics, comparing the death occurring from medical errors to the equivalent of a jumbo jet crashing every […]