MDR vs IVDR medical devices and IVDs compared

MDR applies to medical devices and accessories, and the MDR text expressly separates its scope from in vitro diagnostic medical devices.

IVDR applies to in vitro diagnostic medical devices and accessories, including IVD software when the intended purpose fits the IVDR definition.

Start with intended purpose and data source, then determine which regulation applies to each product or module, or record that it is outside both regimes. For a combined release, identify separately qualified MDR and IVDR products or modules.

MDR uses medical-device classification rules that route devices into MDR risk classes such as class I, IIa, IIb, and III.

IVDR classifies IVDs as A, B, C, or D under seven Annex VIII rules. Classification considers the device's intended purpose and the risk to the individual and public health; class D carries the highest risk.

Do not translate an MDR class into an IVDR class. Re-run the classification rule set under the regulation that applies to the intended purpose.

For MDR, class I devices are generally under manufacturer responsibility, while class IIa, IIb, and III devices require an appropriate level of notified-body involvement.

IVDR class A devices generally use manufacturer self-declaration unless supplied sterile. Class A sterile, B, C, and D devices require notified-body involvement under Article 48, with the assessment scope increasing by class and device type.

Confirm the notified body's IVDR designation and relevant device codes. An MDR designation does not establish IVDR authority.

MDR technical documentation should support the device description, intended purpose, classification, general safety and performance requirements, risk management, clinical evaluation, PMS, UDI, and conformity route.

IVDR technical documentation should support the IVD intended purpose, classification, performance evidence, UDI, EUDAMED, PMS, vigilance, and conformity route for the IVD product.

Use a shared document only when it is mapped to both MDR and IVDR requirements; otherwise maintain separate files and cross-references.

MDR evidence centers on clinical evaluation and clinical evidence, including PMCF where applicable, to support safety and performance throughout the device lifecycle.

IVDR performance evaluation must establish scientific validity, analytical performance, and, where applicable, clinical performance. The performance evaluation and its report are updated across the lifecycle with post-market performance follow-up and PMS data.

Identify which evidence supports the analyte or marker relationship, measurement performance, and correlation with the clinical condition or process. Do not label an MDR clinical evaluation as an IVDR performance evaluation.

MDR devices need UDI handling and Basic UDI-DI linkage. Since 28 May 2026, the Actor, UDI/Device, and Notified Bodies and Certificates modules have been mandatory where applicable. The Vigilance and Post-Market Surveillance module remains in development, and the Market Surveillance module is for competent authorities and the Commission.

IVDR devices also use UDI and the applicable mandatory EUDAMED modules, including IVD-specific device or kit handling. The Vigilance and Post-Market Surveillance module remains in development.

Use each mandatory EUDAMED module only for the actors and records in its scope, and continue the applicable national vigilance and PMS processes until that module becomes mandatory. Do not reuse an MDR UDI or Basic UDI-DI for an IVDR device unless the UDI rule and product identity actually allow it.

MDR manufacturers need PMS and vigilance records for the MDR device, including serious incidents and field safety corrective actions where reportable.

IVDR manufacturers need PMS and vigilance records for the IVD device, and UDI can be part of reporting serious incidents and field safety corrective actions.

One complaint intake system can feed both regimes, but triage must identify the device, UDI, applicable regulation, report type, and authority or EUDAMED route.

MDR artifacts can be reused only where the same product boundary, intended purpose, risk control, evidence method, and device version support the MDR requirement.

IVDR artifacts can be reused only where the same facts support the IVD intended purpose, performance claim, classification, UDI, and PMS or vigilance obligation.

Create a bridge note for every shared artifact; otherwise a reviewer cannot tell whether evidence proves MDR conformity, IVDR conformity, or only a general quality-system control.

MDR applies to medical devices and accessories, and the MDR text expressly separates its scope from in vitro diagnostic medical devices.

IVDR applies to in vitro diagnostic medical devices and accessories, including IVD software when the intended purpose fits the IVDR definition.

Start with intended purpose and data source, then determine which regulation applies to each product or module, or record that it is outside both regimes. For a combined release, identify separately qualified MDR and IVDR products or modules.