ZeptoMetrix®, an Antylia Scientific company, has announced it has successfully completed its first EU Quality Management System Audit from British Standards Institution BSI, NB 2797, one of the notified bodies under the new In Vitro Diagnostics Regulation (IVDR). The certification applies to the portfolio of ZeptoMetrix NATtrol™ control products that are the industry’s preferred standard for molecular diagnostics testing and are supplied ready to use as independent third-party quality control materials.
“The IVDR is mandatory for any manufacturer of in vitro diagnostic devices (IVDs) to issue declarations of conformity, CE mark their products and to get them recertified in compliance with the new regulation,” said Glenn Harrall, Vice President of Quality and Regulatory, Antylia Scientific.
"ZeptoMetrix is on-track to the full and timely transition from the In Vitro Diagnostics Directive (IVDD) to the IVDR,” added Evangeline Gonzalez, Vice President/General Manager, ZeptoMetrix. “Our customers can be assured of continued availability of our CE-IVD marked portfolio along with our commitment to ongoing new product innovations.”
Requirements of the IVDR regulation came into force on May 26, 2022. ZeptoMetrix CE-marked devices lawfully placed on the market in accordance with IVDD (directive 98/79/EC) prior to the date of application by virtue of a valid certificate may continue to be made available on the market until May 26, 2027.