Three weeks have gone by now since the European Commission published a “latest update” on the medical device sector pages of its website. What does this mean for the sector?
After several years of seeing new medtech regulatory documents published daily at EU level to support the implementation of the Medical Device Regulation and the IVD Regulation, there has been an uncharacteristic hush.
A quick glance at the commission’s medical device sector webpages, for example, shows no new postings among the latest updates...
To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
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.
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.
