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.
Latest From Amanda Maxwell
EU member states need to decide some aspects of the EU’s medical device regulations, such as their competent authority and labeling language, for themselves. Here Italy explains its position.
Despite proposals to alleviate the threat of medtech products being unnecessarily removed from the EU market when their old certificates expire, concerns remain at the highest level and calls for action persist.
Council of the EU recommendations on cancer screening have not changed in some 20 years, yet the increase in cancer rates is alarming. Industry associations, COCIR and MedTech Europe have come out in support of the European Commission’s push for a revision.
As the medtech industry’s demand for EU notified body auditing services continues to grow, uncertainty continues as to where availability lies. But industry could help testing bodies in their planning.
Rising energy costs, challenges in accessing supplies and rapidly changing technology are all factors that mean industry needs a certain and established regulatory structure to help it cope.
Certain CE-marked IVDs may remain on the market for up to three years after the IVD Directive expired. New guidance shows how notified bodies must keep working with manufacturers to ensure their safety.