Month: January 2024

EU Parliament

Proposal to Postpone the EU IVDR

The European Commission has announced a proposal to delay the implementation of Regulation (EU) 2017/746 on In Vitro Diagnostic medical devices (IVDR). Although the IVDR has applied since 2022, data has shown that many manufacturers have not taken the plunge to transition to the new regulation. The previous EU Directive 98/79/EC covering IVDs was considered …

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EU Parliament

Translation and Language Requirements for Medical Device Companies

An official list of language requirements for each EU Member State has been published by the European Commission. This critical document also lists translations required for Graphic User Interface (GUI) used for software / apps, although this information is not available for each country. What’s more, these requirements have been published for both MDR and …

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