Important News for IVD and MD Manufacturers!

Posted on April 25, 2024 By MDSS

Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices was published in ...

Commission proposal on extending IVDR transition and expediting EUDAMED adoption!

Posted on January 26, 2024 By MDSS

Due to concerns about manufacturers facing challenges in meeting the In Vitro Diagnostic Medical Devices Regulation (IVDR) requirements within the allotted time, the European Commission (EC) is once again suggesting an extension of the regulation’s transition period. Simultaneously, the Commi...

Overview of language requirements for manufacturers of medical devices

Posted on January 22, 2024 By MDSS

The European Commission, in collaboration with Member States, has recently released two essential documents outlining language requirements under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Medical Device Regulation). These comprehensive tables have been designed as indispensab...

Important News for IVD and MD Manufacturers!

Commission proposal on extending IVDR transition and expediting EUDAMED adoption!

Overview of language requirements for manufacturers of medical devices

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