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
MedTech Europe is calling for European-wide action on continued availability of medical devices in the immediate aftermath of Brexit as countries divide, and statistics demonstrate potentially major health threats ahead.
While the UK says it will continue to recognize EU27-issued certificates for medical devices in the event of a no-deal Brexit, the EU has not offered to reciprocate. European imaging, health IT and electromedical manufacturers are now pressuring the European Commission to set up limited transition arrangements.
While Eudamed is largely on track, there could be a few months of delay in the availability of certain critical parts of the EU's updated medical device database. Stakeholders are working toward a May 26, 2020, deadline for the full application of the EU Medical Devices Regulation, including Eudamed.
While UDI will be required on all products that come under the scope of the EU's medical device regulations, what is the situation for drug/device combinations? The answer is not simple, and depends on an often-tricky regulatory assessment.
The Medical Devices Regulation (MDR) is the vehicle to clarify the role of EU notified bodies in medicinal products with integral medical devices, such as pre-filled syringes. Now, guidance from the EMA on the MDR shows how the pharma and device sectors are working increasingly collaboratively.
With less than four weeks to go until the UK is due to leave the EU, seven of Medtech Insight's top 10 EU regulatory stories in February focused on what will happen if the UK leaves without a deal – a possibility that has been looking increasingly likely.