At Dynex, we are committed to quality and safety, and dedicated to meeting industry regulatory requirements. We are pleased to announce that we have transitioned to compliance with the In Vitro Diagnostics Regulation (IVDR) 2017/746 as of May 26, 2022, as required by regulation.
Products with manufacturing dates from May 26, 2022, and forward will be certified as compliant to the IVDR regulation. We will no longer certify that instruments comply with the In Vitro Diagnostics Directive (IVDD) 98/79/EC.
Instruments already placed on the market before May 26, 2022, may still be used as they comply with IVDD 98/79 EC and have IVDD certification, until May 27, 2025, as part of the sell-through period allowed by regulation.
Supporting our customers’ needs during this transition is our top priority. Please contact us if you have any questions or need additional information.