MDR covers medical devices and their accessories. IVDR covers in vitro diagnostic medical devices, including products and software whose intended purpose is tied to in vitro examination of specimens.
Use this comparison to separate scope, classification, conformity assessment, documentation, evidence, UDI/EUDAMED, PMS, and vigilance workstreams without assuming one device file can serve both laws.
Structured answer sets in this page tree.
Cited legal and guidance references.
MDR and IVDR are parallel EU medical-device regulations, but they do not route products through the same scope test. Start with intended purpose and data source: a therapeutic, diagnostic, monitoring, or compensating device usually points to MDR, while a product or software used for in vitro examination of human specimens may point to IVDR.
A focused comparison for deciding whether a product, software module, kit, assay workflow, or connected instrument belongs under MDR, IVDR, both, or neither.
Use MDR for medical devices, accessories, and covered non-medical-purpose products where the intended purpose and risk profile fit Regulation (EU) 2017/745.
Use IVDR for in vitro diagnostic medical devices and IVD-related software or accessories where the intended purpose is tied to in vitro examination of specimens.
| Dimension | MDR | IVDR | Operational implication |
|---|---|---|---|
| Scope boundary | 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 record whether the product is MDR-only, IVDR-only, both, or outside both regimes. |
| Classification rules | MDR uses medical-device classification rules that route devices into MDR risk classes such as class I, IIa, IIb, and III. | IVDR uses its own classification rules for IVDs; the available MDR grounding supports the separate IVDR route but not a complete standalone IVDR classification table here. | 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. |
| Trigger | 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. | For IVDR, conformity assessment must be selected under IVDR rules and, where third-party intervention is required, a notified body designated for IVDR is needed. | Confirm the notified body's designation by legislation; an MDR designation is not the same as IVDR coverage. |
| Core obligations | 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. |
| Evidence record | MDR evidence centers on clinical evaluation and clinical evidence, including PMCF where applicable, to support safety and performance throughout the device lifecycle. | IVDR evidence should be handled as performance evidence for the IVD intended purpose rather than copied from an MDR clinical evaluation. | When a product combines medical-device and IVD data, write down which evidence answers the MDR clinical question and which evidence answers the IVDR performance question. |
| UDI and EUDAMED | MDR devices need UDI handling, Basic UDI-DI linkage, and EUDAMED records for the relevant actor, device, certificate, vigilance, PMS, or market-surveillance module. | IVDR devices also use UDI and EUDAMED workflows, including IVD-specific device or kit handling where applicable. | Do not reuse an MDR UDI or Basic UDI-DI for an IVDR device unless the UDI rule and product identity actually allow it. |
| Enforcement | 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. |
| Overlap and reuse | 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. |
| Practical decision rule | 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 record whether the product is MDR-only, IVDR-only, both, or outside both regimes. |
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 record whether the product is MDR-only, IVDR-only, both, or outside both regimes.
MDR uses medical-device classification rules that route devices into MDR risk classes such as class I, IIa, IIb, and III.
IVDR uses its own classification rules for IVDs; the available MDR grounding supports the separate IVDR route but not a complete standalone IVDR classification table here.
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.
For IVDR, conformity assessment must be selected under IVDR rules and, where third-party intervention is required, a notified body designated for IVDR is needed.
Confirm the notified body's designation by legislation; an MDR designation is not the same as IVDR coverage.
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 evidence should be handled as performance evidence for the IVD intended purpose rather than copied from an MDR clinical evaluation.
When a product combines medical-device and IVD data, write down which evidence answers the MDR clinical question and which evidence answers the IVDR performance question.
MDR devices need UDI handling, Basic UDI-DI linkage, and EUDAMED records for the relevant actor, device, certificate, vigilance, PMS, or market-surveillance module.
IVDR devices also use UDI and EUDAMED workflows, including IVD-specific device or kit handling where applicable.
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 record whether the product is MDR-only, IVDR-only, both, or outside both regimes.
The first boundary check is not the product format; it is the intended purpose stated in labels, instructions, promotional materials, sales materials, and the evaluation file. MDR qualification is tied to the medical-device definition and MDR accessories. IVDR qualification is tied to in vitro diagnostic purpose, including software that provides information within the IVDR definition or is specifically intended to work with an IVD.
Do not merge the routes just because the same platform, sensor, software module, or customer workflow is involved. A release may need an MDR file, an IVDR file, or a documented conclusion that one route does not apply.
Both regimes require manufacturers to maintain technical documentation and post-market records, but the evidence question changes. MDR evidence is built around general safety and performance requirements, classification, conformity assessment, clinical evaluation, PMCF where applicable, PMS, vigilance, UDI, and EUDAMED records.
For IVDR, avoid copying the MDR clinical-evaluation file into the IVD file. The comparison should identify the IVDR performance evidence, specimen or assay assumptions, IVD classification, conformity route, UDI, EUDAMED, PMS, and vigilance records that are actually supported for the product.
Separate medical-device and IVD scope, evidence, UDI, EUDAMED, PMS, and vigilance decisions before combining release files or customer assurances.
Use this checklist when a product, software module, assay workflow, connected instrument, kit, or combined release could plausibly sit under MDR, IVDR, or both. The output should be a signed routing memo, not a generic compliance note.
"lifecycle of medical devices"
"Harmonised standards are European standards"
"connect devices with same intended purpose"
"filtered by legislation"
"all medical devices other than in vitro diagnostic medical devices"
"in vitro diagnostic medical devices"