UDI Registration in Swissdamed: Key Insights and Deadlines
With economic operator registration in the Actor module of Swissmedic’s Swissdamed database in force for Swiss…
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Swissmedic Guidance Regarding System & Procedure Packs
Swissmedic has issued a new guidance document outlining the obligations for the assembly and labelling of systems and procedure…
New EU Regulation on eIFUs Adopted by Swissmedic
Swissmedic has adopted EU Commission Implementing Regulation (EU) 2025/1234, which extends the scope of electronic instructions…
Notified Body Proposed Reform: EU Medical Device Governance
The EU medical device regulatory landscape is at a critical juncture, as concerns grow over fragmented implementation and the urgent…
EUDAMED Registration Webinar for MDR & IVDR
Navigating EUDAMED: Streamlined Compliance for EU MDR & IVDR Success We hosted a webinar on navigating EUDAMED and understanding the…
FDA MDUFA 2026: Fees & Relief Update
Effective October 1, 2025, the FDA has increased the annual establishment registration fee by 23% under the Medical Device User…
Top Errors When Importing Medical Devices into Switzerland
In regard to importing medical devices into Switzerland under the former Mutual Recognition Agreement (MRA) with the European Union –…
Expansion of Mexico’s Regulatory Pathway for Medical Devices
Mexico’s expedited regulatory medical device pathway, known as the Equivalence Route, was previously limited to recognizing marketing authorizations issued by…
New Publication from Team-NB on Orphan IVD Devices
On 17 July 2025, Team-NB, the European Association of Medical Devices Notified Bodies – released a comprehensive position paper on…
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