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Europe

Set Alert for Policy and Regulation - Europe

Commission Provides Latest Notified Body Figures: How Does Update Help Industry?

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.

Europe Blocs Medical Device

Latest From Policy, Regulation & Europe

Medicinal Products Expert And Established Devices Leader Head Commission’s Medtech Unit

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.

Europe EU

Will MDR Delays Create Roadblocks For Companion Diagnostics Regulation?

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?

Europe EU

EU Nomenclature Mapping Project News: Will Critical Progress Be Hampered By Tensions?

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.

Medical Device In Vitro Diagnostics

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.

Health Technology Assessment United Kingdom

EU MDR Must Ensure Medtech Innovation Keeps Flowing, Say German MPs

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.

Germany Medical Device

Italy: Companies Advised To Prepare Now For Industry Transparency Rule

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.

Italy Compliance
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