Is it clear which medtech products must demonstrate conformity with EU regulations on cybersecurity? Experts weigh in on the case of an alleged discrepancy between a notified body and a manufacturer on this matter.
Medtech innovators face many changes to EU medical device rules under the new Medical Device Regulation, but the introduction of cybersecurity requirements is perhaps one of the most notable additions, given that no such safety provisions existed under the former medtech directives.
However, the need to demonstrate that a product is cybersecure, in accordance with Annex I of the MDR and guidance outlined in MDCG 2019-16 rev
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.
