Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Updated medtech notified body figures from the European Commission always make headline news. But industry needs to see real appointments now, not a list of tricky-to-understand numbers.
Latest From Policy, Regulation & Europe
Erik Hansson remains deputy head of devices in a move to the European Commission’s DG Sante from DG Grow. He now answers to a newly appointed devices head who shares a common educational background but whose recent pharmaceutical role may unsettle the devices industry.
Companion diagnostics are needed increasingly by pharma companies to justify the safety and effectiveness of their products. With specific first-time EU regulation of these products within sight – and urgently needed – is there a risk of delays to these products being able to demonstrate compliance?
It seems to be game over for anyone who might have been hoping the European Commission would do a U-turn on its decision to use the Italian CND nomenclature as the basis for communication in Eudamed, instead of the well-established GMDN. But GMDN is strong in its resolve to remain a vital global nomenclature service.
Medtronic Wins In England’s NICE Decision On Implantable Monitors For Stroke Patients; Biotronik And Abbott Lose
UK health technology assessment body NICE says that Medtronic’s Reveal LINQ, which transmits data remotely to doctors, is likely to be a cost-effective use of National Health Service resources.
For many, the EU MDR is coming too fast, yet several of its crucial elements are not yet in place. Germany’s liberal FDP MPs say the national government needs to make a stand and address a European issue that will impact German patients. In a motion to parliament, the MPs propose fast-tracking for innovative products and measures to keep orphan devices in circulation.
Members of Italian industry body Confindustria Dispositivi Medici should insert a suitable transparency clause in their agreements with health care professionals, says law firm Osborne Clarke, after the trade association introduced a new requirement relating to payments to HPCs.
All set! This article has been sent to firstname.lastname@example.org.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.