--- title: "EU MDR change assessment workflow" canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/change-assessment-workflow" source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/change-assessment-workflow" author: "Sorena AI" description: "Assess EU MDR device, design, software, intended purpose, QMS, clinical, PMS, UDI, classification, and notified-body impacts before releasing a medical device change." published_at: "2026-05-09" updated_at: "2026-05-09" keywords: - "EU MDR change assessment" - "MDR significant change" - "medical device change control" - "notified body" - "technical documentation" - "UDI" - "PMS" - "EU Medical Device Regulation" - "EU MDR" - "Regulation (EU) 2017/745" --- **[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) --- # EU MDR change assessment workflow 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 workflow* *Change control* ## EU MDR change assessment workflow Use this workflow before releasing a medical device change that may affect design, software, intended purpose, manufacturing, QMS, clinical evidence, PMS, UDI data, classification, or the conformity assessment route. The output is a documented release decision: what changed, whether the change is significant, what MDR files need updates, whether notified-body involvement is needed, and what evidence is retained. EU MDR change assessment should start from the proposed change, not from a generic compliance checklist. Capture the device and Basic UDI-DI affected, compare the change with the approved intended purpose, design, software, QMS, risk, clinical, PMS, and UDI baseline, then decide whether the device can proceed under the existing conformity position or needs notified-body review, certificate action, or a new MDR conformity assessment step. ## 1. Capture the change and the approved baseline Open one change record for the device family, model, Basic UDI-DI, certificate or declaration of conformity, software version, manufacturing site, supplier, label, IFU, risk file, clinical evaluation, PMS plan, and technical documentation affected by the proposal. Compare the proposed change with the baseline that was assessed for conformity. For legacy devices using MDR transitional provisions, Regulation (EU) 2023/607 keeps the no-significant-change condition focused on design and intended purpose, while MDR PMS, vigilance, and registration obligations still apply. - Device and design triggers: new model, changed critical specification, new sensor, energy source, alarm handling, packaging that affects sterility or stability, material/substance change, sterilisation change, or manufacturing/process change that affects conformity. - Software triggers: new medical feature, changed algorithm, major architecture change, new interoperability channel, operating-system change requiring device software modification, or user-interface change that changes how medical data is interpreted. - Intended-purpose triggers: new indication, new clinical condition, new patient or user population, new anatomical site, new deployment method, expanded claim, or promotional change that changes the use presented to users. - Quality and production triggers: QMS change, new or relocated site, supplier substitution, subcontractor change, process validation change, or corrective/preventive action that changes product or process controls. Sources for this answer: - [Regulation (EU) 2023/607 on MDR transitional provisions](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607&ref=sorena.io) - Supports checking legacy-device transition conditions, including the requirement that there are no significant changes in design and intended purpose while MDR PMS, vigilance, and registration requirements apply. - [MDCG 2020-3 Rev.1 on significant changes under Article 120 MDR](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/800e8e87-d4eb-4cc5-b5ad-07a9146d7c90%5Fen?filename=mdcg%5F2020-3%5Fen%5F1.pdf&ref=sorena.io) - Grounds the change categories used here: intended purpose, design, software, substances or materials, sterilisation, administrative and manufacturing changes, and case-by-case evidence. ## 2. Decide whether the change is significant Treat significance as a documented technical and regulatory judgement. For legacy devices, use the MDCG 2020-3 structure: first ask whether the change concerns design or intended purpose; if yes, apply the relevant intended-purpose, design, software, substance/material, and sterilisation questions; if any applicable branch reaches significant change, do not release under the old transition assumption. Do not treat every administrative or supplier change as significant. A manufacturer name, address, authorised-representative, site, supplier, material number, or process-validation change can be outside design or intended purpose when the device specifications and certified conditions remain controlled. The assessment still needs evidence and, where a notified-body agreement requires it, notification or prior approval. - Likely significant intended-purpose changes include expanded indications, new clinical conditions, new users or patient populations, new anatomical sites, or new delivery/deployment methods. - Likely significant design changes include altered operating principle, built-in control mechanism, energy source, alarm system, critical dimensions outside approved specifications, new sensors with a different working principle, or changes that adversely affect safety, performance, usability, or benefit-risk. - Likely significant software changes include algorithm changes that may alter diagnosis or therapy, closed-loop replacement of required user input, major architecture or operating-system changes, new medical functionality, new medical data presentation that changes interpretation, or new interoperability channels. - Likely significant material or sterilisation changes include certain patient-contacting implant or absorbable material changes, medicinal-substance changes, higher toxicological or biological risk, terminal sterilisation method changes, non-sterile to sterile labelling, or packaging changes that affect sterility, stability, microbiological state, or seal integrity. Sources for this answer: - [MDCG 2020-3 Rev.1 on significant changes under Article 120 MDR](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/800e8e87-d4eb-4cc5-b5ad-07a9146d7c90%5Fen?filename=mdcg%5F2020-3%5Fen%5F1.pdf&ref=sorena.io) - Supports the significant-change screening categories and examples for intended purpose, design, software, materials, and sterilisation. - [MDCG 2019-11 Rev.1 on software qualification and classification](https://health.ec.europa.eu/document/download/b45335c5-1679-4c71-a91c-fc7a4d37f12b%5Fen?filename=mdcg%5F2019%5F11%5Fen.pdf&ref=sorena.io) - Supports reassessing software qualification, classification, intended purpose, and combination-device impact when medical device software is changed. ## 3. Recheck classification and conformity assessment route After the significance screen, rerun classification for the changed device. Annex VIII classification is governed by intended purpose, combination use, software that drives or influences another device, duration of use, invasiveness, active-device function, and the highest applicable rule when multiple rules apply. Then confirm whether the current conformity route still fits. Class I devices may generally follow manufacturer responsibility, but class IIa, IIb, and III devices require notified-body involvement. If the change affects approved QMS, product range, design, intended use, claims, approved type, or relevant incorporated substances, MDR Annex VII expects notified-body procedures and contractual arrangements to check significance and assess the proposed change. - Classification output: old class, changed class if any, Annex VIII rule(s), strictest applicable rule, and rationale for combination devices or software. - Conformity-route output: current certificate or DoC, applicable MDR annex route, whether the change is within the certificate scope, and whether a new application, prior approval, supplement, restriction, suspension, or other notified-body decision is needed. - Notified-body output: the submitted change package, notified-body decision or written confirmation, assessment report or supplementary report where applicable, and unresolved nonconformities or conditions. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Grounds MDR classification rules, conformity assessment routes, notified-body role, technical documentation, clinical evaluation, PMS, UDI, and certificate change controls. - [European Commission notified bodies overview](https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies-medical-devices_en?ref=sorena.io) - Supports the role of notified bodies when third-party conformity assessment is required for medical devices. ## 4. Update MDR evidence before release Do not close the change assessment until the affected MDR files have been updated or a reason for no update is recorded. Annex II and Annex III technical documentation should stay aligned with the changed device, including design and manufacture information, GSPR evidence, benefit-risk analysis, risk management, verification and validation, PMS plan, and PMS outputs. Clinical and PMS files need a separate impact check. MDR requires risk management and clinical evaluation to be aligned and regularly updated; PMCF is a continuous process that updates clinical evaluation and feeds risk management when new preventive or corrective measures are needed. - Technical documentation: device description, variants, accessories, Basic UDI-DI, labels and IFU, design/manufacturing data, GSPR checklist, standards/common specifications, verification and validation, software validation, biocompatibility, sterilisation, packaging, shelf-life, and stability evidence. - Risk and clinical evidence: hazard analysis, benefit-risk conclusion, clinical evaluation plan/report, equivalence rationale, claims, contraindications, warnings, PMCF plan, PMCF evaluation report, and any clinical investigation rationale affected by the change. - PMS and vigilance: PMS plan, PSUR or PMS report as applicable, complaint trend signals, CAPA links, field safety corrective action records, and documented rationale for whether the change affects existing safety or performance signals. - UDI and EUDAMED: Basic UDI-DI grouping, UDI-DI assignment, DoC references, product certificate references, EUDAMED device data, and whether a new UDI-DI is required because the change could cause misidentification or traceability ambiguity. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Supports updating technical documentation, risk management, clinical evaluation, PMS, PMCF, conformity evidence, and UDI records after a device change. - [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 assessing whether device changes require new UDI-DI or Basic UDI-DI handling and aligning Basic UDI-DI references with certificates and regulatory documentation. - [European Commission - EUDAMED UDI/device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Supports checking whether changed UDI/device information must be reflected in EUDAMED registration data. *Recommended next step* *Placement: after evidence section* ## Review an MDR change before release Use Sorena to assemble the change baseline, significant-change rationale, classification impact, notified-body path, and updated MDR evidence pack before approving release. - [Open Research Copilot](/solutions/research-copilot.md): Answer EU MDR change-control questions with cited source support. - [Talk through MDR implementation](/contact.md): Review your change assessment, technical documentation, clinical, PMS, UDI, and notified-body evidence model. ## 5. Retain the decision evidence The release decision should be inspectable without reconstructing the assessment from meetings. Keep the change request, baseline comparison, significance rationale, classification memo, conformity-route decision, notified-body correspondence, updated file list, residual assumptions, and final release or escalation approval together. For legacy devices, retain the evidence showing why a change is not significant in design or intended purpose, because MDR transition eligibility depends on that condition. For MDR-certified devices, retain the notified-body decision path when the change affects an approved QMS, design, type, intended use, claims, or relevant incorporated substance. - Minimum decision record: change description, affected device identifiers, affected regulatory baseline, owner, reviewer, decision date, sources used, significant-change conclusion, classification conclusion, conformity-route conclusion, and release restriction if any. - Minimum evidence links: redlined label/IFU, software release notes, design input/output change, verification and validation summary, risk file update, clinical/PMS impact assessment, UDI/EUDAMED impact assessment, QMS/CAPA link, and notified-body or competent-authority correspondence where applicable. - Escalate instead of releasing when the assessment finds a significant design or intended-purpose change, a changed classification, a new notified-body route, insufficient clinical or verification evidence, unresolved PMS/vigilance impact, or missing UDI traceability decision. Sources for this answer: - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Supports retaining conformity evidence, technical documentation, clinical evidence, PMS records, UDI information, and notified-body assessment records. - [MDCG 2020-3 Rev.1 on significant changes under Article 120 MDR](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/800e8e87-d4eb-4cc5-b5ad-07a9146d7c90%5Fen?filename=mdcg%5F2020-3%5Fen%5F1.pdf&ref=sorena.io) - Supports documenting the outcome and making the manufacturer evidence available when a competent authority requests it. ## Primary sources - [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Primary MDR source for classification, conformity assessment, technical documentation, clinical evaluation, PMS, UDI, notified-body procedures, and certificate change controls. - Quote: "classification rules" - [Regulation (EU) 2023/607 on MDR transitional provisions](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607&ref=sorena.io) - Binding source for MDR transitional conditions, including the no-significant-change condition for legacy-device design and intended purpose and continued PMS/vigilance/registration obligations. - Quote: "no significant changes in the design and intended purpose" - [MDCG 2020-3 Rev.1 on significant changes under Article 120 MDR](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/800e8e87-d4eb-4cc5-b5ad-07a9146d7c90%5Fen?filename=mdcg%5F2020-3%5Fen%5F1.pdf&ref=sorena.io) - MDCG guidance source for screening significant design and intended-purpose changes, including software, materials, sterilisation, administrative, and manufacturing-change examples. - Quote: "significant changes in the design or intended purpose" - [MDCG 2019-11 Rev.1 on software qualification and classification](https://health.ec.europa.eu/document/download/b45335c5-1679-4c71-a91c-fc7a4d37f12b%5Fen?filename=mdcg%5F2019%5F11%5Fen.pdf&ref=sorena.io) - MDCG source for reassessing medical device software qualification, classification, intended purpose, and combination-device impact after software changes. - Quote: "potential impact of any changes" - [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - MDCG source for deciding whether a device change requires new UDI-DI or Basic UDI-DI handling and how Basic UDI-DI connects certificates and regulatory documentation. - Quote: "misidentification of the device" - [European Commission - EUDAMED UDI/device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Commission source for checking whether changed UDI/device information must be submitted in EUDAMED. - Quote: "UDI/Device information" - [European Commission notified bodies overview](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 in conformity assessment when third-party intervention is required. - Quote: "conformity assessment procedures" ## 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 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 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. --- [Privacy Policy](https://www.sorena.io/privacy) | [Terms of Use](https://www.sorena.io/terms-of-use) | [DMCA](https://www.sorena.io/dmca) | [About Us](https://www.sorena.io/about-us) (c) 2026 Sorena AB (559573-7338). 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