Regulatory Affairs
June 14, 2022
EU IVDR & MDR regulations
We have worked relentlessly in the last four years to comply with applicable MDR and IVDR requirements. And now we are ready!
News
October 11, 2022
COPAN WASP Regulatory milestones: 2022
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), which regulates access to the European market. This process allowed us to CE-mark all our products, guaranteeing our trusted partners and clients the continuous circulation of all our products throughout Europe without disruption. Overseas, our sample preparator Colibrí™ got its second 510(k) FDA clearance. Read more!
