Turkey may not be part of the EU, but its customs agreement with the bloc enables it to designate notified bodies under the EU’s Medical Device and IVD Regulations. The first such designation has just been announced.
The first Turkish notified body has been designated under the EU’s Medical Device Regulation.
Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi, based in Istanbul, was formerly designated under the Medical Devices Directive (MDD) and has
In recognition of Mental Health Awareness month, Sarah Jenkins, executive director at the National Association for Continence, discussed the mental health issues that often come with incontinence.
The FDA plans to implement artificial intelligence in its scientific review process by 30 June, following a successful pilot. The agency hopes the tool will reduce nonproductive tasks for reviewers amid recent staff cuts. A Chief AI Officer will oversee the rollout and integration.
Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals and laid off librarians have not been reinstated.
