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...

Standards free of charge!

CEN and CENELEC make European standards freely available relevant for the crisis.  Standards are created by standard organizations who carefully draf...

Notified body number 11!

The notified body (NB) designation is moving along. Congratulation to NSAI. We have to note the scope NSAI shows as one of the smaller notified bodies...

X