Expert IVDR Consultants for CE Marking & Technical Documentation (Annex II & III)
As the EU’s In Vitro Diagnostic Regulation (IVDR) replaces the IVDD, IVD manufacturers face a higher bar for documentation, clinical evidence, and ongoing compliance. At RegHelps, we specialize in building complete, Notified Body-ready IVDR Technical Documentation aligned with Annex II & III, ensuring full conformity with EU Regulation 2017/746.
Our Core Activities are the following
How IVDR Consultants Accelerate CE Certification Through Expert Technical Documentation and Performance Evaluation Support
Early CE certification of an IVD device under the EU IVDR framework largely hinges on the quality, completeness, and regulatory alignment of the Technical Documentation, particularly the Performance Evaluation Report (PER). The PER must demonstrate scientific validity, analytical performance, and clinical performance as outlined in Annex XIII of the IVDR. Expert IVDR consultants play a critical role in this process by guiding manufacturers through the rigorous regulatory expectations, ensuring that the evidence presented is comprehensive, scientifically justified, and acceptable to the Notified Body. RegHelps experts knowledge of literature evaluation, data assessment, GSPR alignment, and post-market requirements helps streamline the process, reduce errors, and avoid delays in the Notified Body Technical Documentation review and CE certification.
service related FAQ’s
Based on the number of models and varients the timeline may change. usually the timeline for class B is approx 8-10 montsh and Class D is 14 months.
