Changing Requirements for Manufacturers Under IVDR

This keynote, presented by Dr. Peter Wirtschaft of NSF, explores the profound changes introduced by the EU In Vitro Diagnostic Regulation (IVDR, EU 2017/746) and what they mean for manufacturers. NSF provides consulting, training, and compliance support to medical device and IVD companies across Europe. The session focuses on three critical areas: New IVDR Classification Rules Under the old IVDD, 90% of IVD products could be self-certified. Under IVDR, this shifts dramatically—most devices now require assessment by a notified body. IVDR introduces four risk classes (A, B, C, D). Only Class A non-sterile products can be self-declared; all others require notified body oversight. Classification depends on intended use, ranging from Class D (e.g., HIV tests, blood typing) to Class A (e.g., instruments, consumables). Technical Documentation and Quality Management Systems (QMS) Every manufacturer must maintain complete technical files in line with Annex II and III, including device description, risk management, PMS, and verification/validation data. A full QMS is required under Article 10, with processes for design, production, supplier management, vigilance, and continuous improvement. ISO 13485 provides the framework, but IVDR imposes additional requirements (e.g., unique device identifiers, cybersecurity, PRRC role). Proper structuring of documentation and document management systems is vital to ensure traceability and audit readiness. Performance Evaluation Performance evaluation is central to IVDR compliance, providing the clinical evidence that a device achieves its intended purpose. It requires three key reports: Scientific validity (link between analyte and disease) Analytical performance (sensitivity, specificity, accuracy) Clinical performance (evidence from clinical samples) Literature reviews must be systematic and traceable. In some cases, new performance studies will be required. Transition Timelines The IVDR came into effect 26 May 2022, with staggered transition deadlines depending on device class. Existing devices may remain on the market temporarily if no significant changes are made and PMS/vigilance obligations are met. Class A sterile and higher-risk products require immediate notified body involvement. Strategic Implications OEM–PLM models are heavily affected: private-label manufacturers must now hold full technical documentation or act as distributors. Manufacturers should carefully consider classification strategies, potential return on investment, and whether to separate components (e.g., assays, instruments, software) to optimize compliance and cost. Early gap assessments, process updates, and cross-functional planning are critical to meeting IVDR obligations without disrupting business continuity. Support from NSF Services include gap assessments, QMS implementation, technical file development, performance evaluation support, and mock audits. Resources such as printable classification charts, conformity assessment guides, and training modules are available to help manufacturers manage compliance efficiently. The Main Takeaway The IVDR represents a fundamental regulatory shift: where once self-declaration was the norm, now independent conformity assessment, robust technical documentation, and systematic performance evaluation are mandatory. Preparing early, aligning QMS with ISO 13485, and seeking expert support can make the difference between compliance success and costly delays. Contact NSF today to ensure your IVD business is ready for IVDR. Email us at [email protected] to get started.