--- title: "MDR vs IVDR: medical devices and IVDs compared" canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/mdr-vs-ivdr" source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/mdr-vs-ivdr" author: "Sorena AI" description: "Compare EU MDR and IVDR scope, classification, conformity routes, technical documentation, clinical or performance evidence, UDI, EUDAMED, PMS, and vigilance." published_at: "2026-05-09" updated_at: "2026-05-09" keywords: - "EU MDR" - "EU IVDR" - "Regulation (EU) 2017/745" - "Regulation (EU) 2017/746" - "medical devices" - "in vitro diagnostic medical devices" --- **[SORENA](https://www.sorena.io/)** - AI-Powered GRC Platform [Home](https://www.sorena.io/) | [Solutions](https://www.sorena.io/solutions) | [Artifacts](https://www.sorena.io/artifacts) | [About Us](https://www.sorena.io/about-us) | [Contact](https://www.sorena.io/contact) | [Portal](https://app.sorena.io) --- # MDR vs IVDR: medical devices and IVDs compared Compare EU MDR and IVDR scope, classification, conformity routes, technical documentation, clinical or performance evidence, UDI, EUDAMED, PMS, and vigilance. *Comparison* *EU* ## MDR vs IVDR medical devices and IVDs compared 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 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. ## 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, both, or neither. - **MDR**: Use MDR for medical devices, accessories, and covered non-medical-purpose products where the intended purpose and risk profile fit Regulation (EU) 2017/745. - **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. | Dimension | MDR | IVDR | Operational implication | Sources | | --- | --- | --- | --- | --- | | 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. | [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports using MDR as a separate scope route rather than an umbrella for IVDs.
[Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Supports using IVDR as the comparator route for IVD products. | | 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 cited sources support 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. | [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports avoiding direct translation between MDR classification and IVDR classification.
[Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Supports treating IVDR classification separately from MDR classification. | | 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. | [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports MDR class-based notified-body involvement for conformity assessment.
[Notified bodies for medical devices](https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies-medical-devices_en?ref=sorena.io) - Supports the implementation step to verify notified-body designation for the applicable regulation. | | 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. | [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports MDR technical documentation and its link to classification, conformity assessment, clinical evaluation, PMS, and UDI.
[Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Supports maintaining IVDR-specific technical documentation for IVD products.
[MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Supports Basic UDI-DI linkage to product certificate, declaration of conformity, technical documentation, and safety/performance summaries. | | 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. | [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports keeping MDR clinical-evidence conclusions separate from IVDR performance conclusions.
[Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Supports keeping IVDR performance evidence separate from MDR clinical evaluation. | | 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. | [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Supports IVDR UDI handling, including IVD kit UDI examples in the source support.
[EUDAMED portal](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Supports the EUDAMED module list used for both MDR and IVDR planning. | | 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. | [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports MDR PMS and vigilance lifecycle obligations.
[MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Supports use of UDI for MDR and IVDR serious-incident and field-safety-corrective-action reporting references.
[EUDAMED portal](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Supports routing vigilance and PMS records through the relevant EUDAMED module context. | | 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. | [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports the MDR side of artifact reuse limits across technical documentation, clinical evidence, PMS, vigilance, and UDI.
[Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Supports the IVDR side of artifact reuse limits for IVD products.
[MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Supports connecting reused UDI and device-identity records to the correct documentation and device family. | | 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. | [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports using MDR as a separate scope route rather than an umbrella for IVDs.
[Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Supports using IVDR as the comparator route for IVD products. | Sources for Scope boundary - MDR: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports the MDR scope boundary and exclusion of IVDs from MDR product scope. - Quote: "all medical devices other than in vitro diagnostic medical devices" Sources for Scope boundary - IVDR: - [Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Supports the IVDR side of the qualification test for in vitro diagnostic medical devices. - Quote: "in vitro diagnostic medical devices" Sources for Scope boundary - operational implication: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports using MDR as a separate scope route rather than an umbrella for IVDs. - Quote: "all medical devices other than in vitro diagnostic medical devices" - [Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Supports using IVDR as the comparator route for IVD products. - Quote: "in vitro diagnostic medical devices" Sources for Classification rules - MDR: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports MDR risk classification and class-based conformity assessment routing. - Quote: "division of devices into four product classes" Sources for Classification rules - IVDR: - [Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Supports IVDR classification as a separate rule set for IVD products. - Quote: "in vitro diagnostic medical devices" Sources for Classification rules - operational implication: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports avoiding direct translation between MDR classification and IVDR classification. - Quote: "classification rules" - [Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Supports treating IVDR classification separately from MDR classification. - Quote: "in vitro diagnostic medical devices" Sources for Trigger - MDR: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports MDR class-based notified-body involvement for conformity assessment. - Quote: "an appropriate level of involvement of a notified body" Sources for Trigger - IVDR: - [Notified bodies for medical devices](https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies-medical-devices_en?ref=sorena.io) - Supports checking notified bodies separately for MDR and IVDR legislation. - Quote: "filtered by legislation" Sources for Trigger - operational implication: - [Notified bodies for medical devices](https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies-medical-devices_en?ref=sorena.io) - Supports the implementation step to verify notified-body designation for the applicable regulation. - Quote: "List of notified bodies under Regulation" Sources for Core obligations - MDR: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports MDR technical documentation and its link to classification, conformity assessment, clinical evaluation, PMS, and UDI. - Quote: "technical documentation" Sources for Core obligations - IVDR: - [Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Supports maintaining IVDR-specific technical documentation for IVD products. - Quote: "in vitro diagnostic medical devices" Sources for Core obligations - operational implication: - [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Supports Basic UDI-DI linkage to product certificate, declaration of conformity, technical documentation, and safety/performance summaries. - Quote: "main key in the database and relevant documentation" Sources for Evidence record - MDR: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports MDR clinical evaluation, clinical evidence, and PMCF as device-lifecycle evidence. - Quote: "clinical evaluation" Sources for Evidence record - IVDR: - [Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Supports IVDR-specific performance-evidence framing for IVDs without adding unsupported detail beyond the available source support. - Quote: "in vitro diagnostic medical devices" Sources for Evidence record - operational implication: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports keeping MDR clinical-evidence conclusions separate from IVDR performance conclusions. - Quote: "clinical evidence" - [Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Supports keeping IVDR performance evidence separate from MDR clinical evaluation. - Quote: "in vitro diagnostic medical devices" Sources for UDI and EUDAMED - MDR: - [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Supports MDR UDI and Basic UDI-DI documentation practices. - Quote: "Basic UDI-DI is the main key" Sources for UDI and EUDAMED - IVDR: - [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Supports IVDR UDI handling, including IVD kit UDI examples in the source support. - Quote: "a kit shall be assigned and bear their own UDI" Sources for UDI and EUDAMED - operational implication: - [EUDAMED portal](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Supports the EUDAMED module list used for both MDR and IVDR planning. - Quote: "unique device identification (UDI) and device registration" Sources for Enforcement - MDR: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports MDR PMS and vigilance lifecycle obligations. - Quote: "post-market surveillance and vigilance" Sources for Enforcement - IVDR: - [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Supports use of UDI for MDR and IVDR serious-incident and field-safety-corrective-action reporting references. - Quote: "reporting serious incidents and field safety corrective actions" Sources for Enforcement - operational implication: - [EUDAMED portal](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Supports routing vigilance and PMS records through the relevant EUDAMED module context. - Quote: "vigilance and post-market surveillance" Sources for Overlap and reuse - MDR: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports the MDR side of artifact reuse limits across technical documentation, clinical evidence, PMS, vigilance, and UDI. - Quote: "technical documentation" Sources for Overlap and reuse - IVDR: - [Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Supports the IVDR side of artifact reuse limits for IVD products. - Quote: "in vitro diagnostic medical devices" Sources for Overlap and reuse - operational implication: - [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Supports connecting reused UDI and device-identity records to the correct documentation and device family. - Quote: "connect devices with same intended purpose" Sources for Practical decision rule - MDR: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports the MDR scope boundary and exclusion of IVDs from MDR product scope. - Quote: "all medical devices other than in vitro diagnostic medical devices" Sources for Practical decision rule - IVDR: - [Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Supports the IVDR side of the qualification test for in vitro diagnostic medical devices. - Quote: "in vitro diagnostic medical devices" Sources for Practical decision rule - operational implication: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports using MDR as a separate scope route rather than an umbrella for IVDs. - Quote: "all medical devices other than in vitro diagnostic medical devices" - [Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Supports using IVDR as the comparator route for IVD products. - Quote: "in vitro diagnostic medical devices" ### How should teams decide between MDR and IVDR? - Write the intended-purpose statement first, then mark each claim as MDR-relevant, IVDR-relevant, both, or neither. - 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. Sources for the practical decision rule: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports the MDR side of the final routing decision. - Quote: "all medical devices other than in vitro diagnostic medical devices" - [Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Supports the IVDR side of the final routing decision. - Quote: "in vitro diagnostic medical devices" - [Notified bodies for medical devices](https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies-medical-devices_en?ref=sorena.io) - Supports checking notified-body designation for MDR or IVDR conformity assessment. - Quote: "filtered by legislation" - [EUDAMED portal](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Supports keeping EUDAMED routing visible in the decision record. - Quote: "lifecycle of medical devices" ## Where the MDR and IVDR split 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. - 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. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Grounds the MDR scope boundary for medical devices, accessories, Annex XVI products, and intended-purpose analysis. - [Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Grounds the IVDR side of the comparison for in vitro diagnostic medical devices and IVD-specific intended-purpose routing. ## 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, 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. - 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. - 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. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports the MDR evidence categories for technical documentation, clinical evaluation, PMS, vigilance, UDI, and conformity assessment. - [Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Supports the IVDR evidence boundary where performance evaluation and IVD-specific documentation replace MDR clinical-evaluation assumptions. *Recommended next step* *Placement: after implementation section* ## Route MDR and IVDR work before reusing evidence Separate medical-device and IVD scope, evidence, UDI, EUDAMED, PMS, and vigilance decisions before combining release files or customer assurances. - [Open Research Copilot](/solutions/research-copilot.md): Check MDR and IVDR scope, evidence, and source questions with cited outputs. - [Talk through implementation](/contact.md): Review a product routing memo, evidence index, or release gate. ## MDR vs IVDR checklist This checklist is relevant 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. - 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 through MDR classification rules and IVDR products through IVDR classification rules; 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. - 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-only, IVDR-only, both, or neither, with the facts that would reopen the decision after a claim, software, supplier, assay, data-source, or market-role change. Sources for this answer: - [Notified bodies for medical devices](https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies-medical-devices_en?ref=sorena.io) - Supports this page's analysis of comparison point that MDR and IVDR products may require notified-body conformity assessment under their applicable legislation. - [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Supports UDI and Basic UDI-DI handling across MDR and IVDR, including serious-incident and field-safety-corrective-action references. - [EUDAMED portal](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Supports EUDAMED module coverage for actor registration, UDI/device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance, PMS, and market surveillance. ## Primary sources - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745&locale=en&ref=sorena.io) - Supports the MDR side of the final routing decision. - Quote: "all medical devices other than in vitro diagnostic medical devices" - [Regulation (EU) 2017/746 on in vitro diagnostic medical devices](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746&locale=en&ref=sorena.io) - Supports the IVDR side of the final routing decision. - Quote: "in vitro diagnostic medical devices" - [Notified bodies for medical devices](https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies-medical-devices_en?ref=sorena.io) - Supports checking notified-body designation for MDR or IVDR conformity assessment. - Quote: "filtered by legislation" - [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Supports connecting reused UDI and device-identity records to the correct documentation and device family. - Quote: "connect devices with same intended purpose" - [EUDAMED portal](https://webgate.ec.europa.eu/eudamed?ref=sorena.io) - Supports keeping EUDAMED routing visible in the decision record. - Quote: "lifecycle of medical devices" - [European Commission - harmonised standards overview](https://single-market-economy.ec.europa.eu/single-market/goods/european-standards/harmonised-standards_en?ref=sorena.io) - Commission source for harmonised standards and voluntary use of standards to demonstrate compliance with EU legislation. - Quote: "Harmonised standards are European standards" ## Related Topic Guides - [Custom-made medical devices under the EU MDR | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/custom-made-devices.md): Concise EU MDR FAQ on custom-made device definition, mass-produced exclusions, Annex XIII statements, documentation, conformity assessment, PMS, vigilance, and records to retain. - [EU MDR Annex II and III Technical Documentation](/artifacts/eu/medical-device-regulation/annex-ii-and-iii-technical-documents.md): Build an MDR technical documentation index for Annex II device files and Annex III post-market surveillance evidence, including GSPR, risk, clinical, PMS, UDI, and EUDAMED records. - [EU MDR Annex VIII Classification Guide](/artifacts/eu/medical-device-regulation/annex-viii-classification.md): Classify EU MDR medical devices under Annex VIII using intended purpose, duration, invasiveness, active device and software rules, and conformity assessment impact. - [EU MDR Annex XVI products without a medical purpose](/artifacts/eu/medical-device-regulation/annex-xvi-products.md): cited EU MDR guide for Annex XVI products: listed product groups, common specifications, clinical evidence, notified-body route, UDI, EUDAMED, PMS, and vigilance evidence before launch. - [EU MDR Applicability Test](/artifacts/eu/medical-device-regulation/applicability-test.md): Test whether a product, accessory, software function, or Annex XVI product falls under the EU Medical Device Regulation, and record the evidence for the next classification step. - [EU MDR change assessment workflow](/artifacts/eu/medical-device-regulation/change-assessment-workflow.md): Assess EU MDR device, design, software, intended purpose, QMS, clinical, PMS, UDI, classification, and notified-body impacts before releasing a medical device change. - [EU MDR Checklist for Medical Device Compliance](/artifacts/eu/medical-device-regulation/checklist.md): Practical EU MDR checklist covering qualification, classification, conformity assessment, technical documentation, GSPR, clinical evidence, UDI, EUDAMED, PMS, vigilance, QMS, and legacy transition evidence. - [EU MDR classification workflow](/artifacts/eu/medical-device-regulation/classification-workflow.md): A concrete EU MDR classification workflow for intended purpose, device or accessory qualification, Annex VIII rule selection, Rule 11 software review, class outcome, and notified body impact. - [EU MDR Clinical Evaluation Overview](/artifacts/eu/medical-device-regulation/clinical-evaluation-overview.md): EU MDR clinical evaluation overview covering Article 61, Annex XIV, clinical data sources, equivalence, PMCF, CER evidence, notified body review, GSPR, and benefit-risk support. - [EU MDR Clinical Evaluation Report Template](/artifacts/eu/medical-device-regulation/clinical-evaluation-report-template.md): A cited EU MDR clinical evaluation report template covering intended purpose, GSPR linkage, clinical data appraisal, equivalence limits, PMCF, conclusions, and reviewer signoff. - [EU MDR clinical evidence guide](/artifacts/eu/medical-device-regulation/clinical-evidence.md): cited EU MDR guide to clinical evaluation, clinical investigations, equivalence, PMCF, GSPR support, technical documentation, and notified-body review. - [EU MDR compliance obligations](/artifacts/eu/medical-device-regulation/compliance.md): EU MDR compliance guide for device qualification, classification, conformity assessment, QMS, technical documentation, UDI, EUDAMED, PMS, vigilance, and legacy transition controls. - [EU MDR conformity route workflow](/artifacts/eu/medical-device-regulation/conformity-route-workflow.md): cited EU MDR workflow for classifying a device, choosing the conformity assessment route, preparing technical and QMS evidence, and reaching certificate, DoC, UDI, EUDAMED, and CE outputs. - [EU MDR deadlines and compliance calendar](/artifacts/eu/medical-device-regulation/deadlines-and-compliance-calendar.md): Official source EU MDR calendar for application, legacy-device transition, UDI, EUDAMED, and recurring QMS, technical documentation, clinical, PMS, vigilance, certificate, and change reviews. - [EU MDR Device Classification Guide](/artifacts/eu/medical-device-regulation/device-classification-guide.md): Classify an EU MDR medical device by intended purpose, Annex VIII duration, invasiveness, active-device and software rules, then document the conformity route impact. - [EU MDR EUDAMED and UDI registration](/artifacts/eu/medical-device-regulation/eudamed-and-udi.md): cited MDR guide to Basic UDI-DI, UDI-DI, EUDAMED device registration, actor roles, labels, technical documentation, and UDI data governance. - [EU MDR FAQ: qualification, evidence, UDI, and transition](/artifacts/eu/medical-device-regulation/faq.md): Concise EU MDR FAQ covering device qualification, software classification, accessories, custom-made devices, clinical evidence, UDI, EUDAMED, notified bodies, significant changes, and legacy transition. - [EU MDR Legacy Device Transition](/artifacts/eu/medical-device-regulation/legacy-device-transition.md): cited EU MDR legacy device transition guide covering Regulation (EU) 2023/607 conditions, certificate validity, significant-change limits, surveillance, PMS, vigilance, QMS, and evidence records. - [EU MDR notified body route selection](/artifacts/eu/medical-device-regulation/notified-body-route-selection.md): Choose an EU MDR conformity assessment route by device class, Article 52 option, notified body designation scope, QMS readiness, technical documentation, clinical evidence, and certificate evidence. - [EU MDR penalties and enforcement risk](/artifacts/eu/medical-device-regulation/penalties-and-fines.md): cited EU MDR penalties and enforcement-risk guide covering Article 113, Member State penalty rules, market restrictions, recalls, certificate consequences, and evidence. - [EU MDR PMS and Vigilance Guide](/artifacts/eu/medical-device-regulation/pms-and-vigilance.md): EU MDR guide to post-market surveillance, PMCF updates, PMS reports, PSURs, serious incident reporting, FSCA/FSN handling, trend reporting, and evidence records. - [EU MDR PMS and vigilance records](/artifacts/eu/medical-device-regulation/post-market-surveillance-and-vigilance.md): cited EU MDR guide to PMS plans, PMS reports, PSURs, PMCF updates, serious incident and FSCA reporting, trend reporting, and EUDAMED evidence handling. - [EU MDR PMS Plan Template for Medical Devices](/artifacts/eu/medical-device-regulation/post-market-surveillance-plan-template.md): A cited EU MDR post-market surveillance plan template covering device scope, PMS data sources, PMCF linkage, vigilance, trend reporting, PMSR or PSUR outputs, roles, cadence, and evidence records. - [EU MDR QMS and technical file evidence map](/artifacts/eu/medical-device-regulation/qms-and-technical-file.md): Map EU MDR Article 10 QMS duties to Annex II and Annex III technical documentation, PMS, vigilance, UDI records, and notified-body review evidence. - [EU MDR QMS requirements under Article 10](/artifacts/eu/medical-device-regulation/qms.md): EU MDR QMS guide for Article 10 manufacturer controls covering regulatory strategy, design, risk, clinical evaluation, PMS, vigilance, UDI, suppliers, CAPA, and conformity records. - [EU MDR qualification and borderline products](/artifacts/eu/medical-device-regulation/qualification-and-borderline-products.md): EU MDR qualification guide for medical purpose claims, accessories, software, Annex XVI products, and borderline routes to classification and conformity assessment. - [EU MDR qualification workflow](/artifacts/eu/medical-device-regulation/qualification-workflow.md): A concrete EU MDR workflow for deciding whether a product is a medical device, accessory, Annex XVI product, IVD interface, medicinal-product interface, or non-MDR product before classification and conformity assessment. - [EU MDR requirements checklist](/artifacts/eu/medical-device-regulation/requirements.md): Concrete EU MDR requirements for medical-device scope, classification, GSPR, conformity assessment, technical documentation, QMS, clinical evidence, UDI, EUDAMED, PMS, vigilance, and economic-operator records. - [EU MDR Rule 11 software classification](/artifacts/eu/medical-device-regulation/rule-11-software.md): Classify MDR medical device software under Rule 11 using intended purpose, diagnosis or therapy decision impact, physiological monitoring, conformity route, clinical evidence, and software-change records. - [EU MDR significant changes FAQ: legacy-device transition and notified-body review](/artifacts/eu/medical-device-regulation/faq/significant-changes.md): FAQ on MDR significant changes for legacy devices, including intended-purpose, design, software, material, sterilisation, clinical, QMS, notified-body, and evidence impacts. - [EU MDR Transition Timelines: practical guide](/artifacts/eu/medical-device-regulation/transition-timelines.md): EU Medical Device Regulation guide to Transition Timelines with scope decisions, owner actions, evidence records, cited citations, and practical next steps. - [EU MDR UDI and EUDAMED registration guide](/artifacts/eu/medical-device-regulation/udi-and-eudamed.md): EU MDR guide to Basic UDI-DI, UDI-DI, UDI carriers, EUDAMED actor and device registration, change impacts, and evidence governance. - [EU MDR vigilance reporting workflow](/artifacts/eu/medical-device-regulation/vigilance-reporting-workflow.md): Concrete EU MDR vigilance workflow for incident intake, serious incident assessment, FSCA and FSN handling, trend reporting, EUDAMED caveats, CAPA, PMS, clinical evaluation updates, and records. - [How should Basic UDI-DI and UDI-DI be assigned under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/udi-di-and-basic-udi-di.md): EU MDR FAQ explaining what Basic UDI-DI and UDI-DI identify, how they connect to UDI carriers, EUDAMED records, change triggers, and retained evidence. - [MDR vs AI Act for medical-device software](/artifacts/eu/medical-device-regulation/mdr-vs-ai-act.md): Compare MDR software qualification, classification, clinical evidence, QMS, PMS, UDI, EUDAMED, and notified-body evidence boundaries against cautiously scoped AI Act overlap. - [MDR vs GPSR: medical-device boundary checks](/artifacts/eu/medical-device-regulation/mdr-vs-gpsr.md): Compare MDR medical-device scope with general product-safety fallback questions for borderline, non-medical, and Annex XVI products. - [MDR vs Product Liability Directive evidence comparison](/artifacts/eu/medical-device-regulation/mdr-vs-product-liability-directive.md): Compare EU MDR market-access evidence with Product Liability Directive exposure without treating compliance records as a liability outcome. - [What should an EU MDR PMCF plan and report cover? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/pmcf.md): Under the EU MDR, PMCF is part of PMS and clinical evaluation. See what the plan, activities, report, updates, and retained evidence should cover. - [What should manufacturers do when an EU MDR classification changes? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/class-changes.md): Concise EU MDR FAQ on classification changes, intended purpose, software, notified-body route impact, certificates, technical documentation, and retained evidence. - [When can clinical equivalence be used under the EU MDR?](/artifacts/eu/medical-device-regulation/faq/equivalence.md): EU MDR FAQ on clinical equivalence, including technical, biological, and clinical characteristics, access to equivalent-device data, class III and implantable-device limits, clinical evaluation, PMCF, and retained evidence. - [When do software or products make medical purpose claims under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/medical-purpose-claims.md): EU MDR FAQ on medical purpose claims, intended purpose evidence, software qualification, Annex XVI contrasts, and records to keep. - [When is a PSUR required under the EU MDR and what should it contain? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/psur.md): EU MDR FAQ on PSUR scope, content, update cadence, PMS and PMCF links, notified-body handling, EUDAMED submission, and evidence to retain. - [When is an accessory regulated under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/accessories.md): EU MDR FAQ on when an article is a medical device accessory, how intended purpose affects classification, and what evidence to keep. - [When is software regulated as SaMD under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/software-and-samd.md): Concise EU MDR FAQ on software qualification, intended medical purpose, Rule 11 classification, modules, clinical evidence, change assessment, UDI, and EUDAMED. - [Which devices need an SSCP under the EU MDR and what should it include? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/sscp.md): EU MDR FAQ on when an SSCP is required, who prepares, validates, uploads, and updates it, and what evidence should support the summary. - [Which EUDAMED modules matter under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/eudamed-modules.md): EU MDR FAQ mapping EUDAMED modules to actor registration, UDI/device data, certificates, clinical investigations, vigilance/PMS, market surveillance, and practical records. --- [Privacy Policy](https://www.sorena.io/privacy.md) | [Terms of Use](https://www.sorena.io/terms-of-use.md) | [DMCA](https://www.sorena.io/dmca.md) | [About Us](https://www.sorena.io/about-us.md) (c) 2026 Sorena AB (559573-7338). 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