European IVD CE Marking Services
In the realm of in vitro diagnostic (IVD) devices, obtaining CE marking for European market access is pivotal. Compliance with the European Union’s stringent regulatory standards ensures the safety and efficacy of these devices. With the introduction of the In Vitro Diagnostic Regulation (IVDR 2017/746) in May 2022, the landscape for IVD compliance has undergone a significant transformation.
At Operon Strategist, we offer specialized expertise in European IVD CE marking services, providing tailored support to navigate this intricate regulatory journey.
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Understanding IVD Device Classification and Regulatory Requirements
The classification of In Vitro Diagnostic (IVD) devices in Europe is delineated into four categories:
- General IVD (Self-Certified)
- Self-Testing IVD
- List B IVD (Annex II)
- List A IVD (Annex II)
With the implementation of the IVDR, a refined risk-based classification system comprising Classes A, B, C, and D has been introduced. Notably, a majority of self-testing IVDs will now fall within Class C, while several IVDs previously considered self-certified will be reclassified as higher-risk devices.
Tailored Solutions for IVD CE Marking Success
Operon Strategist, with its wealth of experience and expertise in regulatory compliance, offers an array of services designed to streamline the IVD CE marking process:
1. Classification Assessment: We assist in accurately determining the classification of your IVD device, ensuring alignment with the IVDR’s risk-based class.
2. Technical Documentation Preparation: Our team ensures the meticulous preparation of the Technical Documentation File, showcasing compliance with IVDR requirements, encompassing design specifics, risk assessments, and conformity routes.
3. Notified Body Collaboration: For certain classifications, Operon Strategist facilitates interaction with Notified Bodies, ensuring a comprehensive review and issuance of the CE marking certificate.
4. Regulatory Compliance Support: We provide robust support in reviewing existing documentation, conducting clinical evidence assessments, risk evaluations, and aiding in vigilance and post-market surveillance procedures.
Global Experts in IVD Compliance Across Multiple Regulatory Frameworks
Operon Strategist has a proven track record of assisting numerous IVD companies worldwide, successfully navigating the European regulatory landscape. Our team’s expertise extends beyond Europe, ensuring compliance with diverse regulatory frameworks in various markets.
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Conclusion
In the dynamic realm of IVD regulatory compliance, Operon Strategist stands as an expert partner, offering tailored services that align with clients’ unique needs. Our commitment to excellence and regulatory proficiency empowers IVD manufacturers to achieve CE marking, facilitating market access and contributing to advancements in diagnostic healthcare.
Optimize IVD CE marking compliance in Europe with Operon Strategist’s tailored expertise for streamlined regulatory success. Contact us today to benefit from our specialized support.
