In this week’s podcast, EU regulatory editor Amanda Maxwell brings listeners up to speed on the latest news from the European Union. Topics include discussion of ISO 13485, ongoing industry concerns with MDR implementation, and the Eudamed database expansion.
Listen to the podcast via the player below:
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An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.
Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.
The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.
EU4Health, the main funding instrument for EU health initiatives, has put renewed emphasis on orphan devices in its 2025 work program, published in July.
2026 reimbursement calculations for the list of hybrid DRGs – a mechanism to incentivize day cases over inpatient surgery – will be issued in few weeks’ time. The medtech industry has made its demands known.
The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.
The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.
