We finally obtained all the certificates needed to declare the entire COPAN WASP portfolio compliant with the latest European Union In Vitro Diagnostics Regulation (IVDR).
The one-year-long process – opened last September – allows us to CE-mark all our product classes, including those that had to be evaluated and certified according to the new regulation. As a result, we can now guarantee our trusted partners and clients the continuous circulation of all our products throughout Europe without disruption.
COPAN WASP products whose IVDR compliance is covered by the certificates are classified as class A Sterile (WASP QC TSB tube), class B Medical Device Software (SOFTWARE HALO MEASURE & VISUAL, for the measurement of AST halos), and class C Medical Device Software (PhenoMATRIX, PhenoMATRIX TAG, Radian Expert System and Radian Expert System RAST, for microbial identification and antimicrobial susceptibility assessment).
The new IVDR 2017/746 regulates access to the European market by classifying products into four risk classes, according to the patient and public health risks. To ensure that a product can be marketed within the EU, a Notified Body – TÜV SUD in our case – must evaluate the necessary Quality System and Technical documentation to certify that “the manufacturer has established, documented and implemented a quality management system compliant with IVDR.”
It’s a very exciting time overseas as well: our sample preparator Colibrí™ got its second 510(k) FDA clearance! After last December’s clearance for the preparation of ID MALDI-TOF targets, now its triple vision system, accurate pipettor, and user-friendly interface became available in the US for the preparation of microbial suspension for Antimicrobial Susceptibility Testing with bioMérieux VITEK 2.
Of course, our regulatory activity is not over! As international guidelines keep evolving, we constantly work to make all our products compliant with the latest regulations. Explore below our products & certificates!
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