IVDR Compliance for IVD Manufacturers: Everything You Need to Know

IVDR: The Biggest Change in European IVD Regulation in 20 Years

Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) entered into application on May 26, 2022, replacing the In Vitro Diagnostic Directive (98/79/EC, IVDD). The transition from IVDD to IVDR represents the most significant regulatory change for IVD manufacturers operating in Europe in two decades.

The magnitude of the change is difficult to overstate. Under IVDD, approximately 80% of IVDs were self-certified by manufacturers without any Notified Body involvement. Under IVDR, that landscape is reversed — the vast majority of IVDs now require Notified Body conformity assessment. The new risk classification system, which uses four classes (A, B, C, and D) instead of the IVDD lists, reclassifies most IVDs into higher risk categories that require Notified Body involvement.

This shift, combined with the severely constrained capacity of IVDR-designated Notified Bodies, has created a compliance crisis for the IVD industry that the European Commission has partially addressed through transitional extension regulations. Understanding where you stand in this landscape requires understanding the classification system, the applicable deadlines, and the specific documentation and performance evaluation requirements that IVDR demands.

IVDR Device Classification: Classes A, B, C, and D

IVDR Annex VIII defines the four-class risk classification system that replaces the IVDD list-based approach. Unlike IVDD, which classified devices by reference to specific lists (Annex II List A, Annex II List B, and self-certified), IVDR uses risk-based classification rules similar to the MDR approach for physical devices.

Class A: Low individual risk and low public health risk. Class A devices include general laboratory instruments, sample collection devices (collection tubes, swabs), buffers and reagents used as ancillary products, and staining instruments. Class A devices can be self-certified by the manufacturer, with the exception of Class A devices supplied in sterile condition, which require limited Notified Body involvement for the sterility aspect only.

Class B: Moderate individual risk and/or low public health risk. Class B includes the majority of common diagnostic tests — blood typing reagents (non-high risk groups), tests for non-serious conditions, and general biochemistry analyzers. Class B devices require Notified Body conformity assessment.

Class C: High individual risk and/or moderate public health risk. Class C includes companion diagnostics, tests for life-threatening conditions, tests for serious transmissible diseases, and tests for patient management in intensive care. Class C requires full Notified Body assessment including performance evaluation report review.

Class D: High individual risk and high public health risk. Class D includes tests for blood-transmissible agents (HIV, Hepatitis C), tests used in screening programs with significant public health implications, and NAT tests for pathogens with epidemic potential. Class D devices require Notified Body assessment plus review by EU reference laboratories in many cases.

The reclassification from IVDD to IVDR is frequently upward — a device that was self-certified under IVDD is likely to require Notified Body involvement under IVDR. Conducting a formal IVDR classification analysis for your portfolio is an essential first step.

Performance Evaluation Under IVDR

IVDR Annex XIII defines performance evaluation requirements — the IVD equivalent of clinical evaluation under MDR. Performance evaluation is substantially more rigorous under IVDR than the technical documentation requirements under IVDD.

Scientific validity, analytical performance, and clinical performance: IVDR requires that the performance evaluation demonstrate three distinct aspects. Scientific validity establishes the association between the analyte and the clinical condition. Analytical performance demonstrates the device's ability to correctly detect or measure the analyte (sensitivity, specificity, accuracy, precision, linearity, etc.). Clinical performance demonstrates the device's ability to produce clinical outcomes that correlate with the condition being tested.

Performance studies: For Class C and D devices, and for many Class B devices, the performance evaluation must include data from performance studies (equivalent to clinical investigations for devices). These studies must be conducted in accordance with IVDR Annex XIII and, where applicable, IVDR Article 58 (performance studies involving human subjects), which has specific ethical approval and registration requirements.

Performance Evaluation Report (PER): The PER is the document that consolidates the performance evaluation methodology and findings. It must be current, referenced in the technical documentation, and updated throughout the device lifecycle. The PER integrates with the Post-Market Performance Follow-up (PMPF) plan, which is the IVDR analog of MDR's PMCF.

Common deficiencies: Performance evaluations that rely entirely on literature-based claims without device-specific performance data are a frequent Notified Body finding. Under IVDR, the performance evaluation must be device-specific. Published literature on similar assay methodologies can support but does not replace device-specific performance data.

EUDAMED Registration and UDI Requirements

EUDAMED, the European database on medical devices, applies to IVDs under IVDR as well as to medical devices under MDR. IVD manufacturers must register in EUDAMED and maintain current registration data for their devices.

Economic operator registration: Manufacturer and authorized representative registration in EUDAMED has been mandatory since the IVDR application date. If you have not registered your organization in EUDAMED, this is an immediate compliance gap.

Device registration: Device registration requirements in EUDAMED are being phased in as EUDAMED modules become fully functional. The device registration module (UDI/Device) became available in a limited form, but full mandatory device registration timelines have been subject to updates as EUDAMED development progresses. Monitor EUDAMED operational status and registration requirements on the European Commission's EUDAMED portal.

UDI system: IVDR requires that IVDs carry a Unique Device Identifier (UDI), consistent with the IVDR Article 24 and Annex VI requirements. UDI consists of a device identifier (UDI-DI, identifying the device model) and a production identifier (UDI-PI, identifying the specific unit, lot, or batch). IVD manufacturers must apply UDIs through an FDA-recognized issuing agency (GS1, HIBCC, or ICCBBA) and register UDI-DIs in EUDAMED.

UDI labeling requirements have specific placement and format requirements. For IVDs, the UDI carrier (barcode and/or RFID) must appear on the label of the IVD and, for Class C and D IVDs, on the internal packaging. UDI implementation often requires labeling changes that impact packaging procurement and labeling validation activities.

IVDR Transition Deadlines and What They Mean for Your Portfolio

Similar to MDR, the European Commission enacted transitional extension provisions for IVDs through Regulation (EU) 2022/112, providing extended deadlines for devices that had valid IVDD conformity assessment certificates.

Class D: May 26, 2025. This deadline has now passed. Class D IVDs that do not have IVDR certification must either have obtained it or withdrawn from the EU market.

Class C: May 26, 2026. Class C IVDs must have IVDR Notified Body certification by this date to remain on the EU market.

Class B and Class A sterile: May 26, 2027. All Class B and Class A sterile IVDs must be IVDR-certified by this date.

Conditions for transitional extension: Similar to MDR's 2023/607 requirements, IVDR transitional extensions are conditional. Manufacturers must have had a valid IVDD certificate as of May 26, 2022, and must have entered into a written agreement with a designated Notified Body for IVDR conformity assessment before specified cutoff dates.

For manufacturers who have not yet engaged with an IVDR-designated Notified Body, the situation is urgent for Class D devices (deadline passed) and Class C devices (2026 deadline approaching). Notified Body capacity for IVDR has been severely constrained — some bodies have closed their queues for new applications. If you have not yet contracted with a Notified Body, you must act immediately.