EU Market Surveillance for Medical Devices and IVDs
The Implementing Act has been officially published in the Official Journal as of 27 November 2025 Important Deadlines for Medical Device Manufacturers: 28 May 2026 – EUDAMED becomes mandatory: Any new devices must be registered in the database before being introduced to the market. 28 November 2026 – End of the transition phase: All devices […]
EU Market Access in 2025: Key Insights from the Latest Device Availability Survey
Brussels, Europe – November 28, 2025Â New data presented by the European Commission’s monitoring study has revealed a dramatic impact on the medical device market, showing that nearly half of manufacturers have already pulled products from the EU market rather than navigate the complex transition to the new Medical Device Regulation (MDR) and In Vitro […]
Swissmedic’s New Packaging Rules: How the Updated Guidance Impacts Your Product Labels
Geneva, 01 December 2025 — Swissmedic’s long-standing guidance document on packaging, ZL000_00_021e_WL, might look like a simple rulebook for drug labeling, but its latest version has thrown a new spotlight on medical device manufacturers. While the core of the document focuses on requirements for human medicinal products (HMPs), device makers involved in combination offerings are […]