For companies in the in vitro diagnostic (IVD) sector, achieving IVD CE marking is a crucial step to enter and thrive in the European market. At Maven, we help medical device manufacturers navigate the complex regulatory landscape to ensure their products meet the stringent requirements of the European Union’s In Vitro Diagnostic Regulation (IVDR – EU 2017/746).
What is IVD CE Marking?
IVD CE marking is a certification that confirms an in vitro diagnostic device complies with EU health, safety, and performance standards. It allows manufacturers to market their products within the European Economic Area (EEA). The CE mark demonstrates that the device meets all applicable regulatory requirements, from design and manufacturing to testing and labeling.
Why is IVD CE Marking Important?
For IVD manufacturers, CE marking is not just a regulatory obligation—it is a mark of quality and trust. It assures healthcare professionals, laboratories, and patients that the product delivers accurate, reliable, and safe results. Without IVD CE marking, an IVD device cannot be legally sold in the EEA, potentially limiting market access and business growth.
Key Steps in the IVD CE Marking Process
-
Classification of the IVD Device
Under the IVDR, IVD devices are classified into four categories (Class A, B, C, and D) based on their intended purpose and potential risk. Higher classes require more rigorous conformity assessments. -
Conformity Assessment
The manufacturer must demonstrate compliance with the General Safety and Performance Requirements (GSPRs). For higher-risk devices, this involves working with a Notified Body for independent assessment. -
Technical Documentation
A comprehensive technical file must be prepared, including product description, design details, performance evaluation reports, risk management, and labeling. This documentation proves that the device meets all regulatory requirements. -
Performance Evaluation
Clinical performance studies and scientific validity reports must support the device’s accuracy, reliability, and intended use claims. -
Quality Management System (QMS)
Manufacturers must implement a QMS, often aligned with ISO 13485 standards, to ensure consistent quality across design, production, and distribution processes. -
Declaration of Conformity
Once compliance is confirmed, the manufacturer issues an EU Declaration of Conformity, declaring that the IVD meets all applicable EU regulations. -
Affixing the CE Mark
The CE mark is affixed to the product, packaging, and accompanying documentation, allowing the device to be marketed in the EU.
Maven’s Expertise in IVD CE Marking
Navigating the IVDR can be challenging, especially with the increased requirements for performance evaluation, traceability, and post-market surveillance. Maven provides end-to-end support, including classification guidance, technical file preparation, Notified Body coordination, and QMS implementation. Our regulatory experts ensure a smooth and efficient CE marking process, helping you bring your IVD products to market quickly and compliantly.
Conclusion
IVD CE marking is an essential gateway to the European market for diagnostic device manufacturers. With the IVDR in full effect, compliance demands a thorough understanding of regulatory obligations and meticulous preparation. By partnering with Maven, manufacturers can ensure their IVD devices meet the highest standards of safety, performance, and quality—building trust and expanding their global reach.
