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 In Vitro Diagnostic Tests and Their Performance Commission Working Document – Current...

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...

No CE marking needed!

On a regulatory level the EU allows important devices to be placed on the EU market without the CE mark relevant for the fighting of the COVID-19 cris...

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