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.
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Latest From Amanda Maxwell
While the push for transparency was uppermost in the mind of the European Commission when it drafted the new Medical Device Regulation, the way we are learning about new notified bodies is far from transparent.
Ten key take-home messages from recent interviews with recruitment expert Elena Kyria on the impact of the new medical device regulations on recruitment in the EU. This is the third and final installment of the first part of an ongoing series of articles on this topic. The second series will begin in September.
The official designation of a notified body in the European Commission’s Nando database is the trigger for that notified body to begin testing. But can manufacturers expect immediate service from DEKRA?
The European Commission updates its rolling plan on progress with key document and structures toward implementation of the new medtech regulations every few months. What is new and what is still to come this year?
Another notified body, DEKRA based in Germany, has been added to the list of MDR-accredited bodies. But time is ticking, more are urgently needed and experts are taking to social media to voice their concerns.
The EU notified body situation is a fluid one right now. Standards are rising, new regulations are demanding, capacity is under stress, and some notified bodies appear not to be coping in certain areas of their work.