Large volumes of paper IFU accompanying medical devices are harming the environment, say German medtech organizations. Armed with national survey data, they want to raise the issue of expanding eIFU at European and national levels.
Environmental benefit has emerged as the No. 1 reason why more medtech products sold in the EU should be accompanied by electronic instructions for use (eIFU).
A survey in late June by German medtech cluster MedicalMountains and industry association Spectaris revealed that over 76% of medtech...
With the latest ruling in Germany, there is speculation that the Medical Device Regulation’s confusing Article 11 on software or the device’s timing of gaining its class I category may be to blame for the invidious position Dermanostic has found itself in.
Proposals for substantial changes to oversight of medtech notified bodies are likely to be part of the European Commission’s targeted evaluation of the MDR and IVDR, EU medtech lawyer, Erik Vollebregt, tells Medtech Insight.
How Germany, which has the EU’s largest medtech manufacturing base, is pressing for the MDR to feature on the mission letter for the new European Commission and could influence the pace of change.
MPs from across Germany’s political spectrum grilled a panel of national medtech stakeholders on the problems of the MDR and the EU regulatory system during an hour-long sitting of the Bundestag’s health committee on 5 June.
UK-based Biocomposites will begin selling in the UK its next-generation osteoinductive bone graft substitute, NanoBone, which came with its acquisition of Artoss GmbH in June 2023. Meanwhile, the company has purchased remaining shares in the manufacturers of SYNICEM and Subiton antibiotic bone cements and preformed antibiotic-loaded spacers.
The firm’s dual-chamber leadless pacemaker system with is expected to be a growth driver for Abbott and already has acquired approximately 30%-40% of market share from Medtronic since its approval by the US FDA in July 2023, according to GlobalData.
Amferia is developing an antimicrobial peptide hydrogel dressing to combat infections in acute wounds in humans and veterinary contexts. Supported by €1.2m of new venture capital financing, the company is planning pivotal clinical studies to support an FDA application later this year and CE mark submission in 2026-2027.
