Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Amanda Maxwell

London, UK

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.

Set Alert for Articles By Amanda Maxwell

Latest From Amanda Maxwell

Interim Eudamed Scheme: Early SRN Access To Aid Voluntary Actor Registration

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.

Europe EU

EU Guidance Document To Ensure Devices Are Assessed By Appropriately-Trained Reviewers

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.

Europe EU

Has EU Sorted Expert Panels As Tsunami Of 700 Applications Pour In After Extended Deadline?

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.

Europe EU

Commission Bows To Member State Pressure And Offers Voluntary Concession To Eudamed Database Delay

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.

Europe EU

MDCG Due To Endorse Cybersecurity And Class I Guidances This Week; Expert Panels On Agenda

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.

Medical Device Europe

MDR/IVDR Corrigenda Due Final Sign Off Soon; Big Changes For Devices, Less So For IVDs

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.

EU Europe
See All
UsernamePublicRestriction

Register