---
title: "EU MDR classification workflow"
canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/classification-workflow"
source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/classification-workflow"
author: "Sorena AI"
description: "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."
published_at: "2026-05-09"
updated_at: "2026-05-09"
keywords:
  - "EU MDR classification"
  - "MDR Annex VIII"
  - "Rule 11 software"
  - "medical device classification"
  - "notified body conformity assessment"
  - "EU Medical Device Regulation"
  - "EU MDR"
  - "Regulation (EU) 2017/745"
  - "Annex VIII"
  - "Rule 11"
---
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---

# EU MDR classification workflow

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.

*Workflow* *EU MDR*

## EU MDR classification workflow

Classify a medical device by fixing the intended purpose, qualifying the product as a device, accessory, software, system, procedure pack, or Annex XVI product, then applying the Annex VIII rules to reach class I, IIa, IIb, or III.

Use the outcome to identify the conformity assessment route, notified body involvement, and the classification rationale evidence that belongs in the technical documentation.

EU MDR classification starts with the manufacturer's intended purpose, not with a comparison to a similar product. Article 51 divides devices into classes I, IIa, IIb, and III according to intended purpose and inherent risks, and requires classification under Annex VIII. The classification file should therefore show the product facts, the qualification decision, the Annex VIII rule path, the final class, and the conformity assessment consequence.

## 1. Lock the intended purpose before choosing a rule

Begin with the exact intended purpose in the label, instructions for use, promotional or sales materials, and clinical evaluation. Article 2 defines intended purpose by those manufacturer-supplied materials, and MDCG 2021-24 warns that it is the manufacturer's intended purpose, not accidental use or the class of similar products, that determines the class.

Record the clinical purpose, patient or user group, body contact, duration of use, invasiveness, active function, measuring function, medicinal or biological interaction, software output, and whether the device is used alone, in combination, as a system, or as a procedure pack.

- Evidence to keep: current label and IFU text, claims inventory, clinical evaluation scope, design description, and any marketing claims that could change intended purpose.
- Decision point: if a new release changes the intended purpose, conditions of use, patient population, software output, or body interaction, re-run classification before release.
- Escalation point: if clinical practice has changed so that the intended purpose and classification may have changed, document the review and reassess conformity for the new intended purpose.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Article 2 defines intended purpose using the manufacturer's label, instructions for use, promotional or sales materials, and clinical evaluation.
- [MDCG 2021-24 - Guidance on classification of medical devices](https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf?ref=sorena.io) - Explains that classification is driven by intended purpose and inherent risk, not by accidental use or the class assigned to other similar products.

## 2. Qualify the product before applying Annex VIII

Confirm whether the product is a medical device, an accessory for a medical device, software, a system or procedure pack, an Annex XVI product without an intended medical purpose, or outside MDR scope. Article 2 includes software in the medical device definition where the manufacturer intends it for a listed medical purpose, and it defines accessories as articles intended to enable or directly assist a device's medical functionality.

For software, separate three questions: whether it has its own medical purpose, whether it drives or influences a hardware medical device, and whether it only performs storage, archival, communication, simple search, or non-medical administrative functions. MDCG 2019-11 treats software with a medical purpose as medical device software and explains that software driving or influencing a hardware device can be covered as a part, component, or accessory.

- Device qualification: map the product to Article 2(1) medical purposes such as diagnosis, prevention, monitoring, prediction, prognosis, treatment, alleviation, investigation, replacement, modification, or conception support.
- Accessory qualification: identify the specific device the accessory enables or directly assists, and show how the accessory is intended to support that device's intended purpose.
- Software qualification: record input data, output data, patient-specific action, medical purpose, whether the output supports individual patient decisions, and whether the software is independent or drives another device.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Article 2 defines medical devices, accessories, active devices, systems, procedure packs, and intended purpose.
- [MDCG 2019-11 - Qualification and classification of software](https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_11_guidance_en_0.pdf?ref=sorena.io) - Provides the qualification steps for medical device software, including accessory status, software that drives or influences hardware, patient benefit, and non-medical software exclusions.

## 3. Select the Annex VIII rule and resolve overlaps

Apply Annex VIII from the product facts, not from the preferred route. Start with non-invasive, invasive, active, and special-rule categories, then document why each potentially relevant rule applies or does not apply. MDCG 2021-24 identifies the classification criteria as duration of contact, invasiveness, local or systemic effect, toxicity, affected body part, and dependence on an energy source.

If more than one rule or sub-rule applies based on the intended purpose, apply the strictest rule that results in the higher classification. For systems and procedure packs, classification depends on the intended use of the combination; where the combination includes non-CE-marked devices, incompatible use, or sterilisation outside manufacturer instructions, the pack may need to be treated as a device in its own right.

- Rule memo: list each Annex VIII rule screened, the device fact that triggered or excluded it, and the final rule selected.
- Overlap check: record the higher-class rule when multiple rules apply, especially for software plus active device functions, implantable use, medicinal substances, nanomaterials, contraception, sterilisation, or substance-based devices.
- Dispute path: when a notified body is involved and the manufacturer and notified body disagree on Annex VIII application, Article 51 provides referral to the relevant competent authority.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Article 51 requires Annex VIII classification and sets the competent-authority dispute path for manufacturer and notified-body classification disagreements.
- [MDCG 2021-24 - Guidance on classification of medical devices](https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf?ref=sorena.io) - Provides practical interpretation of Annex VIII rules and the risk criteria used to choose the correct rule.

## 4. Apply Rule 11 for medical device software

For medical device software, test Rule 11 specifically. Software that provides information used for diagnosis or therapeutic decisions is class IIa unless the decision impact can cause death or irreversible deterioration, making it class III, or serious deterioration or surgical intervention, making it class IIb. Software intended to monitor physiological processes is class IIa, unless it monitors vital physiological parameters where variations could create immediate danger to the patient, making it class IIb. All other software is class I.

Also check Annex VIII implementing rules. Software that drives or influences the use of another device falls in the same class as that device; independent software is classified in its own right. Where Rule 11 and another rule both apply, use the strictest applicable rule.

- Rule 11a evidence: the medical decision supported, the significance of the software output, the patient condition or healthcare situation, and the harm scenario if the output is wrong.
- Rule 11b evidence: the physiological process monitored, whether the parameter is vital, the use setting such as intensive care, anaesthesia, emergency care, routine check-up, or home monitoring, and why variation could or could not cause immediate danger.
- Implementation rule evidence: whether the software is independent, controls hardware, modifies hardware state, supplies hardware-function output, or combines its own medical purpose with driving another device.

Sources for this answer:

- [MDCG 2019-11 - Qualification and classification of software](https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_11_guidance_en_0.pdf?ref=sorena.io) - Explains MDR software qualification, Annex VIII implementing rules for software, and Rule 11 classification for diagnosis, therapeutic decisions, monitoring, and other software.
- [MDCG 2021-24 - Guidance on classification of medical devices](https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf?ref=sorena.io) - Summarises Rule 11 outcomes and gives examples for class IIa, IIb, III, and class I software.

*Recommended next step*

*Placement: after classification evidence section*

## Turn MDR classification into a reviewable technical-file record

Use the workflow to document intended purpose, qualification, Annex VIII rule selection, Rule 11 software analysis, final class, conformity route, notified body impact, and release evidence.

- [Open Research Copilot](/solutions/research-copilot.md): Answer MDR classification and conformity-route questions with cited outputs.
- [Talk through implementation](/contact.md): Review your intended purpose, Annex VIII rule memo, software classification, and technical-file evidence.

## 5. Translate class into conformity route and notified body impact

Use the final class to choose the conformity assessment route under Article 52 before placing the device on the market. Class III, IIb, and IIa devices generally require notified body assessment under the Article 52 routes and Annexes IX to XI. Class I devices are generally declared by the manufacturer after technical documentation is drawn up, but class I sterile devices, devices with a measuring function, and reusable surgical instruments require limited notified body involvement for the relevant sterile, metrological, or reuse aspects.

The classification outcome also changes the depth of clinical, PMS, PSUR, UDI, SSCP, and notified-body evidence expected in the technical file. Do not close classification until regulatory, quality, clinical, software, and notified-body planning have checked that the selected route matches the class and special features.

- Conformity route output: final class, selected Article 52 paragraph, selected Annex IX, X, or XI route where relevant, and whether a notified body is required.
- Notified body impact: confirm the notified body is designated for MDR and for the relevant device scope before relying on it for conformity assessment.
- Technical file impact: update Annex II and III technical documentation with the risk class, Annex VIII rule justification, rule-overlap analysis, and evidence supporting the intended purpose.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Article 52 links device class to the conformity assessment routes in Annexes IX to XI and identifies the limited notified-body role for class I sterile, measuring, and reusable surgical instruments.
- [European Commission - Notified bodies for medical devices](https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies-medical-devices_en?ref=sorena.io) - Explains that notified bodies assess conformity where third-party intervention is required and that the Commission publishes designated notified bodies in NANDO.

## Classification rationale evidence pack

The classification rationale should be reviewable without reconstructing the workflow from meetings or emails. Keep it with the technical documentation and refresh it when claims, software functions, hardware combinations, body-contact facts, clinical use, or applicable guidance change.

- Product facts: device description, intended purpose, indications, contraindications, patient population, user group, anatomical site, contact duration, invasiveness, active function, measuring function, sterile status, reusable surgical-instrument status, and combination use.
- Qualification rationale: medical device, accessory, software, part or component, system, procedure pack, Annex XVI product, or non-MDR outcome, with reasons and source citations.
- Annex VIII analysis: rule-screening table, strictest-rule decision, Rule 11 analysis where software is involved, class outcome, and unresolved interpretation questions.
- Route and impact: Article 52 route, notified body need and scope check, clinical evidence implications, PMS or PSUR impact, UDI or SSCP implications where relevant, and approval sign-off before market release.

## Primary sources

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Binding MDR source for intended purpose, device and accessory definitions, Article 51 classification, Article 52 conformity assessment routes, Annex VIII rule application, and technical documentation expectations.
- [MDCG 2021-24 - Guidance on classification of medical devices](https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf?ref=sorena.io) - MDCG guidance source for applying Annex VIII classification criteria, intended-purpose analysis, rule overlaps, class outcomes, and practical classification examples.
- [MDCG 2019-11 - Qualification and classification of software](https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_11_guidance_en_0.pdf?ref=sorena.io) - MDCG guidance source for medical device software qualification, software that drives or influences hardware devices, Rule 11, and independent software classification.
- [European Commission - Notified bodies for medical devices](https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies-medical-devices_en?ref=sorena.io) - Commission source for the role of notified bodies and the NANDO publication of designated bodies for MDR conformity assessment.

## 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): source-linked 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 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 source-linked 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): source-linked 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): source-linked 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): Grounded 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): source-linked 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): source-linked 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): source-linked 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): source-linked 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 source-linked 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, source-linked 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 IVDR: medical devices and IVDs compared](/artifacts/eu/medical-device-regulation/mdr-vs-ivdr.md): Compare EU MDR and IVDR scope, classification, conformity routes, technical documentation, clinical or performance evidence, UDI, EUDAMED, PMS, and vigilance.
- [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.


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