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
The new Eudamed database may be delayed for two years, but the European Commission wants to allow early access to Single Registration Numbers before Eudamed goes live in 2022 to aid voluntary registration in the interim.
How do notified bodies ensure that their personnel, and the teams they allocate for conformity assessment of medical devices, have the precise knowledge and expertise needed? A new EU document gives guidance on this.
Only just over a month ago there were fears that the implementation of the EU Medical Device Regulation was going to be hampered by a lack of expert panel applicants. Now it seems there is no shortage. The news raises lots of questions about when and how the structure will now work.
The European Commission’s announcement of a lengthy delay to the Eudamed database launch date has generally been met with dismay, with member states challenging the decision. Now there is news of a concession.
Not only is the EU due to be endorsing key guidance documents this week, but recent headline topics, including appointing expert panels and the delay in setting up the Eudamed database feature on end of week Medical Devices Coordination Group meeting agenda.
The European Parliament is about to sign off corrigenda to the Medical Devices and IVD Regulations. The headline news is a longer transition period for a huge swathe of class I products, but there are other changes too.