A lifetime dedicated to passionately following medtech regulations seems a big claim, but Amanda Maxwell, regulatory affairs editor, wears the badge and has a loyal list of followers. She still remains as passionate about the implications of changing requirements as 30 years ago when analysing the drafting of the first EU medical device and IVD rules. She tirelessly picks through the draft and existing requirements and the implications of the background debate, to bring you the reality of what the latest developments and discussions mean for you. Amanda knows where to get the vital information, who can offer the best inside knowledge and how to get it to readers quickly. She is well respected in the industry and has a history of moderating and chairing at many high-profile meetings in the EU and the US ( MedTech Forum (EU), AdvaMed (US), DIA (EU and US)), and a strong network of contacts among regulators, consultants, lawyers and EU institutions. She has also been active in consulting and training companies in EU medical device regulations. Amanda has been known to pick up stories while swimming in the Aegean, and there are rumours of her renting a window cleaning scaffold outside the European Commission, but she won’t comment on this and would not recommend anyone to try it!
When not writing, Amanda is a strong well-being advocate and loves health and wellness apps. She rarely sits still and loves to be out and about, actively participating in life with family and friends.
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Amanda Maxwell
Why are there so many more pages and articles in the latest, likely final, versions of the Medical Devices Regulation and the IVD Regulation compared to the 2016 versions? What do these changes mean for the regulations, which are due to be adopted imminently?
Industry recognizes considerable work has been done on cleaning up the texts of EU's future Medical Device and IVD Regulations. But it emphasized that further work is needed in the implementation phase to bring legal certainty and clarification.
The Council of the European Union published the latest versions of the Medical Device and IVD Regulations, and the timelines to full implementation are now clearer.
Members of the TEAM-NB association, which account for about half of the anticipated future force of EU medtech notified bodies, are taking a coordinated approach to applying for redesignations against the new EU Medical Device and IVD Regulations. Will they succeed?
Will notified bodies be let off the hook when it comes to unannounced audits now that it is official they are not mandatory? And what is the role of national courts in notified body liability?
France has introduced new requirements for medical devices that go beyond EU requirements. Is the EU going to stand by and let this happen? And which products, exactly, will they apply to?