IvDO adopted!

It is confirmed. Switzerland adopted the new Regulation on In-vitro Diagnostics (IvDO), which mainly refers to the IVDR. The provisional text in Germa...

UKCA marking!

The new UKCA marking is required after July 1, 2023. Manufacturers should start acting now to ensure the deadline is met. When affixing the UKCA marki...

New MDCG guidance documents!

The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. Legally non-bin...

COVID-19 info!

European Commission Comments for Consideration on COVID-19 info on In Vitro Diagnostic Tests and Their Performance Commission Working Document –...

MDR Delay!

2020.04.24 In writing and set in stone with the publication on the Official Journal of the European Union. Here is the publication. 2020.04.20 On Frid...

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