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 –...

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...

Statement on Covid-19

The Covid-19 outbreak is rapidly changing lives and business practices worldwide. Increasingly stricter measures are being implemented to protect publ...

Warning – For risk class I devices!

Products, which stay class I under the MDR, must be in full compliance by May 26 2020! MDSS concern: Some clients seem to be under the impression that...