Industry and healthcare professionals generally welcome the European Commission's proposal to broaden the use of eIFUs. However, more official statements are still awaited.
The European Commission has published a draft implementing regulation which would allow instructions for use in electronic format (eIFU) for all medical devices intended for exclusive use by healthcare professionals.
It is inviting feedback on the text, which will be published on its website, with the comment period due to...
The US FDA posted eight device-related warning letters in June, touching on industry sectors from urinalysis test strips to ophthalmic devices.
Waters Corp. will acquire Becton Dickinson’s Biosciences and Diagnostics business for $17.5bn, doubling its TAM to $40B. Analysts praise the flow cytometry addition but see weaker growth in diagnostics.
MedTech Europe wants the EU to continue its commitment to reach a negotiated tariff solution with the US and measured restraint amid escalating trade tensions.
The European Commission is focusing on how tiny particles behave to help create an EU industrial “powerhouse.”
