NEWS
Stay up to date with the latest news and announcements in your industry.
FDA Issues Informed Consent Final Guideline
Rockville, August, 2023. FDA revised and issued "Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors". The document represents finalized guidance, superseding the first guidance issued in September 1998, and updating draft guidance from...
We’re Back!
Boston, August, 2023 We've been gone for a bit - as in three years. Did we miss anything? Or, more to the point, is there anything that didn't change? Well, there was that whole pandemic thing. Amazing that despite the EU MDR and IVDR both written in 2017, and both...
EU Clarifies Software Regulated under MDR/IVDR
Brussels, November, 2019 With a little more than a half year to MDR implementation, the EU Medical Device Coordination Group released MDCG 2019-11, a 28 page Guidance on Qualification and Classification on Software in Regulation (EU) 2017/745 MDR and 2017/746...
Australia TGA Issues Electronic IFU Guidance
August, 2018, Symonston, Australia. Australia’s TGA (Therapeutic Goods Administration) issued a guidance on electronic instructions for use (eIFU) for medical devices earlier this month. Similar to current EU requirements, Australian regulations require all medical...
RED replaces R&TTE 13 June 2017 – Is Your Legacy Medical Device Ready?
Does your legacy CE Marked medical device emit RF? Medical Device Manufacturers who complied with the essential requirements of the R&TTE (Radio and Telecommunications Terminal Equipment) Directive which has been in effect for the past 15 years will have until 13...
MEDDEV 2.7.1 Rev 4 Turns Up Clinical Compliance Heat This Summer
The latest revision of MEDDEV 2.7.1 published last month is more or less a total re-write, and may up-end manufacturer's clinical plans as well as studies underway to support CE Marking but not yet submitted in tech file or design dossier. In line with the...