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.
This comparison helps separate scope, classification, conformity assessment, documentation, evidence, UDI/EUDAMED, PMS, and vigilance workstreams without assuming one device file can serve both laws.
MDR and IVDR are parallel EU regulations with different scope and classification rules. A product is an when its intended purpose is to provide specified medical information through in vitro examination of specimens derived from the human body, including blood and tissue donations. Use MDR for other medical devices and accessories. A product's format or use in a laboratory does not decide the route.
Side-by-side comparison
MDR vs IVDR: medical device and IVD routing
A focused comparison for deciding whether a product, software module, kit, assay workflow, or connected instrument belongs under MDR, IVDR, or neither, and for identifying separately qualified MDR and IVDR products or modules in a combined release.
Use MDR for medical devices, accessories, and covered non-medical-purpose products where the intended purpose and risk profile fit Regulation (EU) 2017/745.
Second framework
IVDR
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.
Supports the IVDR side of the qualification test for in vitro diagnostic medical devices.
in vitro diagnostic medical devices
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.
Supports MDR risk classification and class-based conformity assessment routing.
division of devices into four product classes
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.
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.
Supports MDR class-based notified-body involvement for conformity assessment.
an appropriate level of involvement of a notified body
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.
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.
Supports MDR technical documentation and its link to classification, conformity assessment, clinical evaluation, PMS, and UDI.
technical documentation
IVDR technical documentation should support the IVD intended purpose, classification, performance evidence, UDI, EUDAMED, PMS, vigilance, and conformity route for the IVD product.
MDR evidence centers on clinical evaluation and clinical evidence, including PMCF where applicable, to support safety and performance throughout the device lifecycle.
Supports MDR clinical evaluation, clinical evidence, and PMCF as device-lifecycle evidence.
clinical evaluation
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.
Article 56 and Annex XIII establish scientific validity, analytical performance, clinical performance, the performance evaluation report, and lifecycle updates.
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.
Confirms the modules mandatory since 28 May 2026, the actors covered by the Market Surveillance module, and the modules still under development.
As of 28 May 2026
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.
Confirms the current mandatory-module and in-development-module status for MDR and IVDR workflows.
Vigilance and post-market surveillance (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.
Confirms which modules are mandatory, which actors use the Market Surveillance module, and that the Vigilance and Post-Market Surveillance module remains in development.
Vigilance and post-market surveillance (in development)
Supports MDR PMS and vigilance lifecycle obligations.
post-market surveillance and vigilance
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.
Supports use of UDI for MDR and IVDR serious-incident and field-safety-corrective-action reporting references.
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.
Supports the MDR side of artifact reuse limits across technical documentation, clinical evidence, PMS, vigilance, and UDI.
technical documentation
IVDR artifacts can be reused only where the same facts support the IVD intended purpose, performance claim, classification, UDI, and PMS or vigilance obligation.
Supports the IVDR side of artifact reuse limits for IVD products.
in vitro diagnostic medical devices
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.
Supports the IVDR side of the qualification test for in vitro diagnostic medical devices.
in vitro diagnostic medical devices
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.
Supports the IVDR side of the qualification test for in vitro diagnostic medical devices.
in vitro diagnostic medical devices
Operational implication
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.
Supports MDR risk classification and class-based conformity assessment routing.
division of devices into four product classes
IVDR
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.
Supports treating IVDR classification separately from MDR classification.
in vitro diagnostic medical devices
Trigger
MDR
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.
Supports MDR class-based notified-body involvement for conformity assessment.
an appropriate level of involvement of a notified body
IVDR
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.
Supports the implementation step to verify notified-body designation for the applicable regulation.
List of notified bodies under Regulation
Core obligations
MDR
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.
Supports MDR technical documentation and its link to classification, conformity assessment, clinical evaluation, PMS, and UDI.
technical documentation
IVDR
IVDR technical documentation should support the IVD intended purpose, classification, performance evidence, UDI, EUDAMED, PMS, vigilance, and conformity route for the IVD product.
Supports Basic UDI-DI linkage to product certificate, declaration of conformity, technical documentation, and safety/performance summaries.
main key in the database and relevant documentation
Evidence record
MDR
MDR evidence centers on clinical evaluation and clinical evidence, including PMCF where applicable, to support safety and performance throughout the device lifecycle.
Supports MDR clinical evaluation, clinical evidence, and PMCF as device-lifecycle evidence.
clinical evaluation
IVDR
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.
Article 56 and Annex XIII establish scientific validity, analytical performance, clinical performance, the performance evaluation report, and lifecycle updates.
Operational implication
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.
Supports keeping IVDR performance evidence separate from MDR clinical evaluation.
in vitro diagnostic medical devices
UDI and EUDAMED
MDR
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.
Confirms the modules mandatory since 28 May 2026, the actors covered by the Market Surveillance module, and the modules still under development.
As of 28 May 2026
IVDR
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.
Confirms the current mandatory-module and in-development-module status for MDR and IVDR workflows.
Vigilance and post-market surveillance (in development)
Operational implication
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.
Confirms which modules are mandatory, which actors use the Market Surveillance module, and that the Vigilance and Post-Market Surveillance module remains in development.
Vigilance and post-market surveillance (in development)
Supports MDR PMS and vigilance lifecycle obligations.
post-market surveillance and vigilance
IVDR
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.
Supports use of UDI for MDR and IVDR serious-incident and field-safety-corrective-action reporting references.
reporting serious incidents and field safety corrective actions
Operational implication
One complaint intake system can feed both regimes, but triage must identify the device, UDI, applicable regulation, report type, and authority or EUDAMED route.
Supports routing vigilance and PMS records through the relevant EUDAMED module context.
vigilance and post-market surveillance
Overlap and reuse
MDR
MDR artifacts can be reused only where the same product boundary, intended purpose, risk control, evidence method, and device version support the MDR requirement.
Supports the MDR side of artifact reuse limits across technical documentation, clinical evidence, PMS, vigilance, and UDI.
technical documentation
IVDR
IVDR artifacts can be reused only where the same facts support the IVD intended purpose, performance claim, classification, UDI, and PMS or vigilance obligation.
Supports the IVDR side of artifact reuse limits for IVD products.
in vitro diagnostic medical devices
Operational implication
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.
Supports the IVDR side of the qualification test for in vitro diagnostic medical devices.
in vitro diagnostic medical devices
Operational implication
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.
Non-binding MDCG guidance supporting selection of one applicable regulation for software with mixed MDR and IVD data sources.
determining which regulation to apply
Practical decision rule
How should teams decide between MDR and IVDR?
Write the intended-purpose statement first, then identify whether MDR, IVDR, or neither applies to each product or module. For mixed MDR and IVD data sources, determine which source substantially drives the intended purpose.
Classify the product under the applicable regulation instead of translating a class from the other regime.
Pick the conformity route and notified body based on the applicable legislation and device class.
Build separate clinical or performance evidence conclusions, then map any shared technical, UDI, EUDAMED, PMS, or vigilance artifact to both regimes.
Reopen the decision after a claim change, software change, specimen or data-source change, supplier change, market-role change, incident, or new notified-body finding.
Non-binding MDCG guidance supporting the routing decision for software with MDR, IVD, or mixed data sources.
determining which regulation to apply
1
Section 1
Where the MDR and IVDR split
The first boundary check 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 requires an in vitro examination of specimens derived from the human body and an intended purpose within the IVDR definition, such as information on a physiological or pathological process, congenital impairment, predisposition to a condition or disease, suitability for a potential recipient, likely treatment response, or therapeutic monitoring.
Representative IVDR products include reagents, calibrators, control materials, test kits, specimen receptacles, instruments, and software when their intended purpose meets that specimen-examination test. General laboratory equipment and research-use products are not pulled into IVDR only because an IVD laboratory uses them; the manufacturer's stated purpose and the product's actual characteristics still need review.
Software is not an IVD merely because it receives laboratory data. It falls under IVDR when the manufacturer intends the software, alone or in combination, to provide information that meets the IVD definition. Software that only stores, transfers, searches, or displays data without an IVD purpose needs a separate qualification analysis.
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.
Check whether the product acts on, monitors, diagnoses, treats, compensates for, or supports a medical purpose as a medical device.
Check whether the product or software uses in vitro examination of specimens, IVD instrument output, or IVD-derived data as the basis for the claimed result.
For software, record whether it is a device in its own right, an accessory, or software that drives or influences another device.
Separate Annex XVI non-medical-purpose MDR products from IVDR products; do not treat aesthetic-purpose MDR coverage as an IVD route.
Grounds the IVDR side of the comparison for in vitro diagnostic medical devices and IVD-specific intended-purpose routing.
in vitro diagnostic medical devices
2
Section 2
Evidence files are similar in shape, different in substance
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, do not copy the MDR clinical-evaluation file into the IVD file. IVDR performance evaluation is a continuous lifecycle process covering scientific validity, analytical performance, and, where applicable, clinical performance. The performance evaluation report must bring those reports together and assess whether the clinical evidence supports the intended purpose and applicable general safety and performance requirements.
Maintain one comparison memo that names the product, intended purpose, data inputs, user, specimen or patient context, market role, and applicable regulation.
Keep separate evidence indexes for MDR clinical evaluation and IVDR performance evaluation, even when the same quality system or risk process supports both. For IVDR, identify the analyte or marker relationship, specimen types, analytical performance parameters, clinical-performance claims, data gaps, and post-market performance follow-up.
Tag shared documents, such as risk management, software validation, standards mapping, UDI assignments, and EUDAMED registrations, to the regulation and device version they support.
Use the comparison as a release gate: unresolved scope, classification, evidence, UDI, or EUDAMED gaps should block reuse of the other regime's file.
Use this checklist when a product, software module, assay workflow, connected instrument, or kit could fall under MDR or IVDR, or when a combined release contains separately qualified MDR and IVDR products or modules. Record the result in a controlled routing memo with the facts, rules, evidence owners, and review triggers.
Intended purpose: compare claims in labels, instructions, promotional material, sales material, clinical evaluation, and performance evaluation drafts.
Data source: identify whether the result depends on patient/device observations, in vitro specimen examination, IVD instrument output, or mixed inputs.
Classification: map MDR devices to classes I, IIa, IIb, or III under MDR Annex VIII. Map IVDs to classes A, B, C, or D under IVDR Annex VIII, with class D as the highest risk class. Do not translate class labels across regimes.
Conformity route: identify whether a notified body is needed and which certificate, technical documentation assessment, or manufacturer declaration path is relevant. Under IVDR, class A devices generally use manufacturer self-declaration unless supplied sterile; class A sterile, B, C, and D devices require the IVDR conformity route and notified-body involvement specified in Article 48.
Documentation: prepare MDR technical documentation and clinical evidence separately from IVDR technical documentation and performance evidence unless a shared artifact is explicitly mapped.
UDI and EUDAMED: assign Basic UDI-DI and UDI records to the actual device, kit, system, procedure pack, or configurable product and register data in the relevant EUDAMED workflow.
PMS and vigilance: route complaints, serious incidents, field safety corrective actions, PSUR or PMS reports, and EUDAMED vigilance data to the regulation that controls the device.
Boundary decision: document MDR, IVDR, or neither for each product or module; for a combined release, identify any separately qualified MDR and IVDR products or modules. Record the facts that would reopen the decision after a claim, software, supplier, assay, data-source, or market-role change.
Supports this page's analysis of comparison point that MDR and IVDR products may require notified-body conformity assessment under their applicable legislation.
Supports EUDAMED module coverage for actor registration, UDI/device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance, PMS, and market surveillance.
Articles 2, 47, and 48 and Annexes VIII and XIII support the IVD definition, A-D classification, conformity routes, and three-part performance evaluation.
Primary IVDR source for in vitro diagnostic medical-device scope and the IVDR side of the comparison.
Grounds the IVDR side of the comparison for in vitro diagnostic medical devices and IVD-specific intended-purpose routing.
Supports the IVDR evidence boundary where performance evaluation and IVD-specific documentation replace MDR clinical-evaluation assumptions.
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Supports the IVDR side of the qualification test for in vitro diagnostic medical devices.
Supports using IVDR as the comparator route for IVD products.
Article 47 and Annex VIII establish IVDR classes A-D and the classification rules.
Supports treating IVDR classification separately from MDR classification.
Supports maintaining IVDR-specific technical documentation for IVD products.
Article 56 and Annex XIII establish scientific validity, analytical performance, clinical performance, the performance evaluation report, and lifecycle updates.
Supports keeping IVDR performance evidence separate from MDR clinical evaluation.
Supports the IVDR side of artifact reuse limits for IVD products.
Supports the IVDR side of the final routing decision.
Commission portal source for EUDAMED's MDR and IVDR database role and its modules.
Supports EUDAMED module coverage for actor registration, UDI/device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance, PMS, and market surveillance.
Supports routing vigilance and PMS records through the relevant EUDAMED module context.
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Supports keeping EUDAMED routing visible in the decision record.
Commission source explaining notified bodies for MDR and IVDR and the NANDO list used to identify designated bodies by legislation.
Supports this page's analysis of comparison point that MDR and IVDR products may require notified-body conformity assessment under their applicable legislation.
Supports the implementation step to verify notified-body designation for the applicable regulation.
Show 1 more
Supports checking notified-body designation for MDR or IVDR conformity assessment.
Confirms the modules mandatory since 28 May 2026, the actors covered by the Market Surveillance module, and the modules still under development.
Confirms the current mandatory-module and in-development-module status for MDR and IVDR workflows.
Confirms which modules are mandatory, which actors use the Market Surveillance module, and that the Vigilance and Post-Market Surveillance module remains in development.
"As of 28 May 2026"
More quoted passages
"Vigilance and post-market surveillance (in development)"
Articles 2, 47, and 48 and Annexes VIII and XIII support the IVD definition, A-D classification, conformity routes, and three-part performance evaluation.
Article 48 establishes IVDR conformity-assessment routes by class, including the class A sterile exception.