Anatolia has reached another major milestone by receiving its first IVDR Class D product certificate for Bosphore HBV Quantification Kit. Class D covers the detection and monitoring of the highest-risk infectious diseases, demanding the most rigorous clinical evaluations in the industry. By meeting these peak safety standards, this prestigious certification reinforces our commitment to excellence in in vitro diagnostics and takes our certified product scope one step further.
Scope and Importance of the
Class D Certificate
Under the European Union’s IVDR framework, the Class D category represents the highest risk level for in vitro diagnostic devices. It is strictly reserved for critical applications, such as safeguarding blood supplies and detecting highly transmissible, life-threatening pathogens.
Securing a Class D certification is a challenging process that demands the most rigorous clinical evidence, stringent quality management audits, and comprehensive technical assessments to guarantee absolute patient safety. Achieving this status proves a manufacturer’s capability to meet the pinnacle of European regulatory standards.
Our first product to earn this certification, Bosphore HBV Quantification Kit, is a Real-Time PCR solution vital for the quantitative detection of Hepatitis B (HBV) and monitoring patient responses to antiviral treatments. By elevating our portfolio to include Class D diagnostics, we have significantly expanded our IVDR-certified product scope and reinforced our position as a globally trusted provider of critical healthcare solutions.
Our IVDR Transition Process and
Previous Achievements
The IVDR (In Vitro Diagnostic Medical Devices Regulation) 2017/746 introduces much stricter assessment criteria for placing medical devices on the market. The requirement for manufacturers of all risk classes to have an IVDR Quality Management System (QMS) began on May 26, 2025, and the date by which IVDD certificates will expire and the transition for Class D will be completed is set for December 31, 2027.
Proactively adapting to this timeline, Anatolia managed its transition process from IVDD to IVDR in the previous period, successfully certifying its quality management system and initial products. Anatolia has achieved a significant milestone by becoming the first molecular diagnostics manufacturer in Türkiye to obtain the IVDR certification. Both our initial IVDR certificates and this new Class D certificate were granted following successful audits conducted by the EU-authorized Notified Body QMD Services GmbH.
Driven by the momentum of our recent milestones, we remain dedicated to building on our proven track record by further expanding our IVDR-certified product portfolio.
Discover more about the IVDR certification process by watching our latest video.
