This page brings together informational articles on developments, documents, initiatives and topics relevant to medical devices and in vitro diagnostic medical devices.
Unlike the MDR/IVDR Resources, which are designed as introductory and evergreen guides, these articles offer a more contextual look of specific updates and topics.
The latest published articles are collected below.
FDA Approves a Pediatric Heart Valve That Can Be Expanded as Children Grow
The decision concerns the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve intended for pediatric patients with congenital pulmonary …
Swissdamed: Importer Linking to Registered Devices Now Available
Since October 1, 2026, importers have been able to link their actor registration to devices already registered in the Swiss …
HTA and medical devices: fourth 2026 request period for JSCs now open
From 23 September to 21 October 2026, it is possible to submit requests for Joint Scientific Consultation under the European …
DIGICAP: European Project Launched to Digitalise MDR and IVDR Conformity Assessment Processes
The initiative aims to support the transition from document exchange to processes based on structured data. The project’s launch does …