The EU now has a total of 45 notified bodies under the MDR.
TÜV SÜD Denmark is the first certification body in Denmark to be designated under the EU’s Medical Device Regulation.
Its scope of designation includes active and implantable and non-implantable medical devices as well as some non-active implants and...
Daye is launching an at-home reproductive hormone testing service in the UK, utilizing a painless upper arm blood collection method. The product’s UKAS lab accreditation helps build credibility with healthcare providers.
EU4Health, the main funding instrument for EU health initiatives, has put renewed emphasis on orphan devices in its 2025 work program, published in July.
In return for building a successful US export business, Switzerland has been handed a 39% tariff effective immediately by the Trump administration. Diplomatic channels have been reopened to undo the tariff. Meanwhile, the medtech industry is looking to develop OUS markets for Swiss exporters.
HistoSonics’ CEO Michael Blue describes the deal as a win-win for all stakeholders and plans to use the money to expand clinical indications, as well as the global reach, for its Edison system.
Medical device firms often have serious compliance gaps, a recent Veeva MedTech survey found. Only 50% of the companies surveyed are confident in their global registration data, with 70% reporting inconsistencies during audits. The report recommends automation and better data governance.
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.
