Amanda Maxwell

#medtech regulations expert at @Medtech_Insight. #medicaldevices, #IVDs & #drug/device combinations. Own opinions. @Pharma_Intelligence

[Amanda Maxwell @MedtechAmanda]

#MTF2024 is underway! Around 1,000 delegates, 60 sessions, and many critical EU #medtech regulatory topics on the agenda #EUMDR #EUIVR. Come and say “hi” if you are here!

[Amanda Maxwell @MedtechAmanda]

Cyprus has an #EUMDR notified body, the 39th to be designated in the EU. Numbers nearly at that 40 mark now as the MDR amending time has extended transition periods too. More time, and more bandwidth for #medtech. But not an excuse…https://t.co/iiHtYVtzSE https://t.co/QNUs7zJbAg

[Amanda Maxwell @MedtechAmanda]

Loving the Christmas analogy responses here to this debate over the urgency to comply with the IVD Regulation. Thank you to @gertwbos, Andreas Stange and Graeme Tunbridge for a fascinating discussion about impact of the #EUIVDR amending regulation and how…https://t.co/u8aCthsvnX

[Amanda Maxwell @MedtechAmanda]

It's now official. Substantially more time for manufacturers of Annex XVI to comply with the MDR, on certain conditions. Given the growth in the number of people offering aesthetic services involving such devices and the relatively…https://t.co/kRMjV5QFp8 https://t.co/1E1ChYgGC4

[Amanda Maxwell @MedtechAmanda]

A second chance at obtaining free clinical advice from an expert panel for your innovative high-risk medical device. Would love to hear from any company that is successful in the first or second phases. #medtech #EUMDR https://t.co/y6oPzWXbGD

[Amanda Maxwell @MedtechAmanda]

Sad news. Fond memories of John Webster, RIP.#medtech #EUMDR #EUIVDR #medtechlabelling https://t.co/L1ZuVz7SSR

[Amanda Maxwell @MedtechAmanda]

Very interesting: first ethics lab for artificial intelligence (AI) in healthcare; the Responsible and Ethical AI in Healthcare Lab (REAiHL) #EUMDR #EUIVDR #medtech @ElizaSlawther https://t.co/HWk802iAYI

[Amanda Maxwell @MedtechAmanda]

Returning from a lovely holiday in la bella Italia, I was struck how quiet the EU machinery had been during my absence in terms of churning out new #EUMDR #EUIVDR documents. This article explains why I believe the EU is entering a…https://t.co/KFtiK4bljT https://t.co/AcxKGcp7AO

[Amanda Maxwell @MedtechAmanda]

Regulating high-risk #medtech #AI applications commensurate with clinical risk is the key to proportionate regulation, according to experts at CORE-MD. Interestingly, they state that the level of clinical evidence and the criteria used by regulators to ev…https://t.co/LdVixMbGhV

[Amanda Maxwell @MedtechAmanda]

How big an issue is this hiatus in #EUMDR notified body designations, do you think, given that manufacturers must have their legacy product applications submitted to notified bodies by 26 May 2024 if they wish to benefit from exten…https://t.co/MRcEp1rWO8 https://t.co/gqNYZefV8F

[Amanda Maxwell @MedtechAmanda]

Need to understand how notified bodies will provide assurance that certain #EUMDR legacy products can continue on market despite certificates expiring? And want to know what is required from manufacturers? A brief summary here: #medtech https://t.co/tUNkB2kH7X

[Amanda Maxwell @MedtechAmanda]

Unusual to see #EUMDR guidance come directly from the European Commission rather than the MDCG. The document stresses the importance of "conciseness" when it comes to sponsors submitting the summary of the #clinical investigation r…https://t.co/7QkNdgGmFg https://t.co/Kg8BTcq8d8

[Amanda Maxwell @MedtechAmanda]

FREE UPDATE! No need for a subscription to read this piece. My latest round-up focuses on the EU's role in global medtech regulations and the direction in which new developments are heading as latest technology challenges regulator…https://t.co/mPZOvzh3Af https://t.co/DbCJ80YFuZ

[Amanda Maxwell @MedtechAmanda]

Expert panel opinions on notified bodies' clinical evaluation assessment reports of their clients' high-risk devices are now a key feature of the EU medtech system. With the tenth opinion #EUMDR published, trends are emerging that…https://t.co/Do2meyJsef https://t.co/IHlyonUF8k

[Amanda Maxwell @MedtechAmanda]

How should the design of personalized #medicaldevices be regulated when the breadth of variation makes it impossible to fully assess compliance? And how should the production system be regulated for such devices? These are question…https://t.co/w0yKUYw25F https://t.co/QZPqihIQkk

[Amanda Maxwell @MedtechAmanda]

How the US supported EU #medtech stakeholders get their message across at the highest levels to effectively slow down the speed of full implementation of the #EUMDR. Are EU stakeholders as engaged when it comes to US #medtech regulations, MedTech Europe? https://t.co/8QmCXSfxv9

[Amanda Maxwell @MedtechAmanda]

Which authorities globally are going to be communicating together to flag up concerns or potential threats with your #medicaldevices and #IVDs? How quickly will local #medtech worries come under a global spotlight? #IMDRF https://t.co/xz3lizNpBZ

[Amanda Maxwell @MedtechAmanda]

A new Spanish #medtech law details where Spain's requirements may differ from other EU member states when it comes to #EUMDR measures. Most of it is permissible and expected. But has Spain gone too far in one or two areas? https://t.co/8D3hpMPtUE

[Amanda Maxwell @MedtechAmanda]

So very controversial. I guess an artificial womb would be a Class III medical device? Is the EUMDR ready for such responsibility should it materialize? Or is this among the developments that would prompt a revision? #medtech #medicaldevice #artificialwomb https://t.co/77CBeYMlK9

[Amanda Maxwell @MedtechAmanda]

Quick! Quick! #EUMDR and #EUIVDR deadlines now look tenable given the extended transition periods for legacy products and current notified body resources. But they won't be Team-NB warns, unless manufacturers up their game when it…https://t.co/T25ElDnhNo https://t.co/2pxubMswt1