For VitaVitro, 2025 is destined to be an extraordinary year. As the company celebrates its 10th anniversary, exciting news arrives from BSI (British Standards Institution), the CE Notified Body: the VitaVitro Vitrification Kit and VitaVitro Warming Kit have both obtained CE certification (Certificate Nos. MDR775399 and MDR775400) issued by the institution.
The CE mark represents a mandatory safety requirement for products entering the EU market, serving not only as a critical passport to EU access but also as one of the most widely recognized regulatory compliance symbols globally. For Class III medical devices, obtaining CE certification under the EU Medical Device Regulation (MDR) is an exceptionally rigorous and challenging process. It typically requires compliance with the "Conformity Assessment Based on Quality Management System and Technical Documentation Evaluation" pathway to ensure continuous regulatory adherence throughout the product lifecycle. Successful CE certification is built on a robust quality management system (QMS). Since 2018, VitaVitro has undergone seven consecutive years of EU-regulated QMS annual audits. Coupled with the newly obtained CE certification for its Class III products, it is not only validated the company’s commitment to high-quality operations and stringent management standards but also reinforce its philosophy of continuous improvement and optimization.