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Language requirements for Manufacturers – Europe

Different legal provisions outlined in Regulation (EU) 2017/745 on medical devices (MDR) permit Member States to est…
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Mexico: Modifications to Medical Device Registration

In August 2023, the Mexican regulatory authority for medical devices, COFEPRIS, released an updated guidance documen…
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Is Regulatory Team Overworking but Unproductive?

We’re taught from an early age that hard work is key for success. What we’re not taught is that hard work comes in t…
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Swissmedic Device/IVD Database Key Dates

Swissmedic now handles registration of economic operators, medical devices and In-vitro diagnostic medical devices d…
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EUDAMED Requirements of Legacy Device Registration in UDI Module

MDR 2017/745 and IVDR 2017/746 EU laws establish an EU identification system for medical devices based on a Unique D…
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