Following the timelines laid out in the European Commission’s new implementing regulation for Annex XVI non-clinical devices is not for the faint-hearted. It involves multiple cross-referencing between several commission regulations. Medtech Insight clarifies the situation.
Manufacturers of products without an intended medical purpose that fall under the EU’s Medical Device Regulation (MDR) and are listed in its Annex XVI are going to have longer to comply with the requirements of that text.
The periods are being extended between 18 and 30 months for products that are subject to clinical investigations, and as...
Cecilia Lindgren, Aneira Health’s co-founder and chief science officer, said that the company has “redesigned the diagnostic model.” The subscription-based platform offers clinical-grade and AI diagnostics alongside clinical consultation.
Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.
J&J's EMEA head of digital solutions, Julia Fishman, talks about the major hurdles in scaling digital innovation, tips for clinical adoption and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.
Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.
