With so many discussions around future change now in the medtech regulatory melting pot as 2025 kicks off, it is unsurprising to see an intense calendar of EU meetings ahead. But which topics deserve the most focus?
The European Commission’s Medical Device Coordination Group, which plays a key role in the implementation of the Medical Device and IVD Regulations, is due to have 10 days of umbrella meetings spread over five sessions during 2025, to discuss matters relating to the implementation of the EU’s medtech regulations.
They will be spread as follows: 18-19 February; 1-2 April; 3-4 June; 14-15 October; 10-11 December.
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.
Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.
Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.
Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.
The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.
The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.
