---
title: "EU MDR FAQ: qualification, evidence, UDI, and transition"
canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/faq"
source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/faq/items"
author: "Sorena AI"
description: "Concise EU MDR FAQ covering device qualification, software classification, accessories, custom-made devices, clinical evidence, UDI, EUDAMED, notified bodies, significant changes, and legacy transition."
published_at: "2026-05-09"
updated_at: "2026-05-26"
keywords:
  - "EU MDR FAQ"
  - "medical device qualification"
  - "Rule 11 software"
  - "clinical evaluation"
  - "PMCF"
  - "PSUR"
  - "SSCP"
  - "UDI"
  - "EUDAMED"
  - "notified body"
  - "legacy devices"
  - "EU Medical Device Regulation"
  - "EU MDR"
  - "Regulation (EU) 2017/745"
  - "Medical device software"
---
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# EU MDR FAQ: qualification, evidence, UDI, and transition

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 FAQ* *Regulation (EU) 2017/745*

## EU MDR FAQ

Short answers to recurring EU Medical Device Regulation questions on scope, classification, software, clinical evidence, UDI, EUDAMED, notified bodies, and transition planning.

Use this page to separate MDR facts that change conformity assessment and technical documentation from generic compliance housekeeping.

This FAQ answers practical EU MDR questions that affect product scope, regulatory route, clinical evidence, market registration, and post-market obligations. It is written for product, quality, regulatory, and legal teams that need concise source-linked answers before changing claims, software functions, technical documentation, or launch plans.

## Browse sub-FAQ modules

### [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.

- 4 items

### [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.

- 3 items

### [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.

- 4 items

### [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.

- 2 items

### [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.

- 2 items

### [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.

- 4 items

### [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.

- 4 items

### [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.

- 3 items

### [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.

- 2 items

### [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.

- 3 items

### [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.

- 2 items

### [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.

- 3 items

Browse all indexed questions: [/artifacts/eu/medical-device-regulation/faq/items](/artifacts/eu/medical-device-regulation/faq/items.md)

## All FAQ items

*Page 1 of 2. Showing 20 of 36 items.*

### [What counts as a custom-made device under the EU MDR?](/artifacts/eu/medical-device-regulation/faq/custom-made-devices.md#what-counts-as-a-custom-made-device-under-the-eu-mdr)

*Module: [Custom-made medical devices under the EU MDR](/artifacts/eu/medical-device-regulation/faq/custom-made-devices.md)*

The definition turns on patient-specific design and prescription control. The device must be made in accordance with a written prescription from a person authorised by national law, the prescription must give specific design characteristics under that person's responsibility, and the device must be intended for one particular patient or user.

- Keep the prescription and evidence that the prescriber was authorised under national law.
- Identify the patient or user by name, acronym, or numerical code in the Annex XIII statement.
- Record why the device is not a mass-produced adaptable device or an industrially mass-produced prescription 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 custom-made devices and excludes mass-produced adaptable devices and industrially mass-produced prescription devices.

### [What statement and documentation must the manufacturer keep?](/artifacts/eu/medical-device-regulation/faq/custom-made-devices.md#what-statement-and-documentation-must-the-manufacturer-keep)

*Module: [Custom-made medical devices under the EU MDR](/artifacts/eu/medical-device-regulation/faq/custom-made-devices.md)*

Before placing a custom-made device on the market, the manufacturer must follow Annex XIII and draw up the required statement. Article 21 also requires the device to be accompanied by that statement, made available to the identified patient or user.

- Retain manufacturer and manufacturing-site details, authorised representative details where applicable, and device identification data.
- Include the prescription-specific characteristics, the authorised prescriber and health institution where applicable, and the identified patient or user.
- State conformity with Annex I general safety and performance requirements, and explain any requirements not fully met.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Articles 10, 21, and Annex XIII set the custom-made-device statement, documentation, availability, and retention requirements.

### [How is conformity assessment different?](/artifacts/eu/medical-device-regulation/faq/custom-made-devices.md#how-is-conformity-assessment-different)

*Module: [Custom-made medical devices under the EU MDR](/artifacts/eu/medical-device-regulation/faq/custom-made-devices.md)*

Custom-made devices do not follow the standard class I, IIa, IIb, or III conformity assessment routes used for non-custom-made devices. Article 52(8) points custom-made-device manufacturers to Annex XIII and the Annex XIII statement before placing the device on the market.

- Do not use the custom-made route for ordinary configurable or adaptable catalogue devices.
- Confirm whether the device is class III and implantable before deciding whether notified-body conformity assessment is required.
- Keep the route decision with the prescription, classification rationale, Annex XIII statement, and manufacturing documentation.

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 distinguishes custom-made devices from ordinary conformity assessment routes and adds notified-body conformity assessment for class III custom-made implantable devices.
- [Regulation (EU) 2023/607 on MDR and IVDR transitional provisions](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607&ref=sorena.io) - The amendment text confirms the MDR change requiring notified-body involvement for class III custom-made implantable devices.

### [What PMS and vigilance evidence should be retained?](/artifacts/eu/medical-device-regulation/faq/custom-made-devices.md#what-pms-and-vigilance-evidence-should-be-retained)

*Module: [Custom-made medical devices under the EU MDR](/artifacts/eu/medical-device-regulation/faq/custom-made-devices.md)*

Annex XIII requires the manufacturer to review and document post-production experience, including PMCF where applicable, and to apply necessary corrective action. Serious incidents and field safety corrective actions must be reported under Article 87 when the manufacturer learns of them.

- Retain complaint, incident, field safety corrective action, PMCF, corrective-action, and benefit-risk review records.
- For class IIa, IIb, and III custom-made devices, keep the PSUR with the Annex XIII documentation and justify any grouped PSUR family.
- Link PMS conclusions back to the prescription characteristics, design rationale, risk management file, and manufacturing controls.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Articles 83 to 87 and Annex XIII support PMS, PSUR, PMCF, vigilance, serious-incident, and field-safety-corrective-action evidence for custom-made devices.
- [MDCG 2022-21 - Guidance on Periodic Safety Update Report under Regulation (EU) 2017/745](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/a7df24c3-d4a3-4218-a8e0-726febfa01c2_en?filename=mdcg_2022-21_en.pdf&ref=sorena.io) - MDCG 2022-21 explains PSUR handling for custom-made devices, including classes IIa, IIb, and III, Annex XIII documentation, availability on request, and grouping justification.

### [Which MDR changes need significant-change screening?](/artifacts/eu/medical-device-regulation/faq/significant-changes.md#which-mdr-changes-need-significant-change-screening)

*Module: [EU MDR significant changes FAQ: legacy-device transition and notified-body review](/artifacts/eu/medical-device-regulation/faq/significant-changes.md)*

For MDR legacy devices, MDCG 2020-3 Rev.1 frames the test around two questions: does the change concern design or intended purpose, and if so is it significant under Article 120(3c), point (b). A significant design or intended-purpose change prevents continued placing on the market under the AIMDD/MDD transition route for that changed device; the manufacturer would need to place the changed device under the MDR route instead.

- Intended purpose: extensions, new indications, new patient or user populations, and new clinical applications are significant; limitations of the existing intended purpose can be non-significant when aligned with the original certification.
- Design and performance: changes that alter control mechanisms, operating principle, source of energy, alarm systems, safety, performance, usability, or risk-benefit can be significant.
- Software: major operating-system, architecture, algorithm, closed-loop, medical-feature, data-presentation, or interoperability changes can be significant; bug fixes, security updates, UI appearance changes, and operating-efficiency changes may be non-significant when they do not affect diagnosis, therapy, usability, or risk-benefit.
- Materials and substances: changes involving long-contact implants, surgically absorbed materials, human or animal origin materials, medicinal substances, or higher biological or toxicological risk can be significant.
- Sterilisation and packaging: changing terminal sterilisation method, sterile status, sterility assurance, seal integrity, stability, or unvalidated shelf-life can be significant.

Sources for this answer:

- [MDCG 2020-3 Rev.1 - significant changes under MDR Article 120](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 used for the design, intended-purpose, software, material, and sterilisation significant-change examples for MDR legacy devices.
- [Regulation (EU) 2023/607 amending MDR transitional provisions](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607&ref=sorena.io) - Binding amendment source for Article 120 transition conditions, including no significant design or intended-purpose changes, QMS, application, written-agreement, and surveillance conditions.

### [What is the notified-body and certificate impact?](/artifacts/eu/medical-device-regulation/faq/significant-changes.md#what-is-the-notified-body-and-certificate-impact)

*Module: [EU MDR significant changes FAQ: legacy-device transition and notified-body review](/artifacts/eu/medical-device-regulation/faq/significant-changes.md)*

MDCG 2020-3 Rev.1 says new AIMDD/MDD certificates are not issued under the transition route. For non-significant changes, the certificate should not be amended, but the notified body may provide written confirmation that the proposed change is not a significant design or intended-purpose change and that the related certificate remains valid if the Article 120 conditions are met.

- Keep the notified-body change submission or rationale, the notified-body written confirmation or decision, and any numbered confirmation letters with the certificate record.
- For approved MDR devices, Annex IX requires notifying the issuing notified body when planned changes to the approved device could affect safety, performance, or conditions of use.
- Do not treat written confirmation for a non-significant legacy-device change as a supplemented AIMDD/MDD certificate.

Sources for this answer:

- [MDCG 2020-3 Rev.1 - significant changes under MDR Article 120](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 used for notified-body verification, certificate confirmation, and the prohibition on issuing new AIMDD/MDD certificates through the transition route.
- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - MDR source for manufacturer QMS, technical documentation, clinical evaluation, record retention, and notified-body approval of changes to approved devices.
- [Regulation (EU) 2023/607 amending MDR transitional provisions](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607&ref=sorena.io) - Binding amendment source for legacy-device transition conditions and notified-body surveillance transfer language.

### [What evidence should be retained?](/artifacts/eu/medical-device-regulation/faq/significant-changes.md#what-evidence-should-be-retained)

*Module: [EU MDR significant changes FAQ: legacy-device transition and notified-body review](/artifacts/eu/medical-device-regulation/faq/significant-changes.md)*

Retain enough evidence for a competent authority, notified body, or decision owner to see the exact change, the pre-change certified state, the Article 120 or MDR provision applied, and why the conclusion follows. MDR Article 10 also requires manufacturers to keep technical documentation up to date and to retain technical documentation, declarations of conformity, and relevant certificates for the required retention period.

- Change description: product, model, Basic UDI-DI where relevant, current certificate or declaration route, affected markets, and release version.
- Significance assessment: intended purpose, design/performance, software, material/substance, sterilisation, clinical evidence, and risk-benefit checks against MDCG 2020-3 Rev.1.
- Approval trail: regulatory owner, quality owner, notified-body submission or rationale, written confirmation or decision, release gate, and trigger for reassessment.
- Documentation updates: technical documentation, QMS change record, clinical evaluation or PMCF inputs, PMS/vigilance links, supplier evidence, validation reports, labelling, and authority or notified-body correspondence.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - MDR source for keeping technical documentation up to date, QMS change control, clinical evaluation, PMCF, and documentation retention.
- [MDCG 2020-3 Rev.1 - significant changes under MDR Article 120](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 used for the case-by-case assessment and evidence that a change is outside design or intended purpose, non-significant, or significant.

### [How should Basic UDI-DI and UDI-DI be assigned under the EU MDR?](/artifacts/eu/medical-device-regulation/faq/udi-di-and-basic-udi-di.md#how-should-basic-udi-di-and-udi-di-be-assigned-under-the-eu-mdr)

*Module: [How should Basic UDI-DI and UDI-DI be assigned under the EU MDR?](/artifacts/eu/medical-device-regulation/faq/udi-di-and-basic-udi-di.md)*

Assign the Basic UDI-DI at the device model grouping level. It is the main key for records in the UDI database and is referenced in documents such as product certificates, EU declarations of conformity, technical documentation, and, where relevant, SSCP or PSUR materials.

- Use the Basic UDI-DI to connect devices with the same intended purpose, risk class, and essential design and manufacturing characteristics.
- Use UDI-DIs for the device and higher packaging levels; shipping containers are not higher levels of packaging for this purpose.
- For devices needing notified-body product certificates, align the Basic UDI-DI grouping with the notified body so certificates and supporting regulatory documents reference the right grouping.

Sources for this answer:

- [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Explains UDI-DI, Basic UDI-DI grouping, package-level UDI-DIs, and when Basic UDI-DIs appear in regulatory documentation.

### [How do UDI carriers, labels, and EUDAMED records fit together?](/artifacts/eu/medical-device-regulation/faq/udi-di-and-basic-udi-di.md#how-do-udi-carriers-labels-and-eudamed-records-fit-together)

*Module: [How should Basic UDI-DI and UDI-DI be assigned under the EU MDR?](/artifacts/eu/medical-device-regulation/faq/udi-di-and-basic-udi-di.md)*

The UDI carrier is the label or device marking mechanism that conveys the UDI, normally through AIDC and, where applicable, human-readable interpretation. It is an additional UDI requirement and does not supersede other MDR labelling requirements.

- Keep the label artwork, package hierarchy, and UDI carrier specification traceable to the assigned UDI-DI and UDI-PI.
- Confirm that UDI/device data submitted to EUDAMED matches the Basic UDI-DI, UDI-DI, packaging level, manufacturer, EMDN, and device characteristics used in regulatory records.
- Do not treat the presence of a UDI-DI in the UDI database as proof of MDR conformity; it is an identifier record, not a conformity decision.

Sources for this answer:

- [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 the distinction between UDI-DI, UDI-PI, UDI carrier placement, package levels, and UDI database data.
- [European Commission - EUDAMED UDI/device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Commission page stating that manufacturers submit UDI/device information in EUDAMED and identifying MDR UDI/device data sets.

### [When do changes trigger a new UDI-DI?](/artifacts/eu/medical-device-regulation/faq/udi-di-and-basic-udi-di.md#when-do-changes-trigger-a-new-udi-di)

*Module: [How should Basic UDI-DI and UDI-DI be assigned under the EU MDR?](/artifacts/eu/medical-device-regulation/faq/udi-di-and-basic-udi-di.md)*

A new UDI-DI is required when a change could lead to misidentification of the device or ambiguity in traceability. MDCG 2022-7 repeats the MDR Annex VI examples and gives practical examples for package quantity and substance-based devices.

- A package quantity change, such as moving from 5 to 10 devices in a package, requires a new UDI-DI for that package because it can create traceability ambiguity.
- For substance-based medical devices, a formulation quantity change or additional medical-purpose claim can require a new UDI-DI when it creates misidentification or traceability risk.
- If a single-use device is reprocessed by a person who becomes the manufacturer under MDR Article 17(2), MDCG 2022-7 says the reprocessed device needs a new Basic UDI-DI and UDI.

Sources for this answer:

- [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Lists UDI-DI change triggers and gives examples for package quantity changes, substance-based devices, and reprocessed single-use devices.

### [What records should be retained?](/artifacts/eu/medical-device-regulation/faq/udi-di-and-basic-udi-di.md#what-records-should-be-retained)

*Module: [How should Basic UDI-DI and UDI-DI be assigned under the EU MDR?](/artifacts/eu/medical-device-regulation/faq/udi-di-and-basic-udi-di.md)*

Keep a record that links the identifier to the product facts that justified it. The useful record is not just the code; it is the grouping rationale, issuing entity rule, packaging level, label or carrier evidence, EUDAMED submission data, and any change assessment that explains why the identifier stayed the same or changed.

- Retain the Basic UDI-DI grouping rationale, including intended purpose, risk class, and essential design or manufacturing characteristics.
- Retain UDI-DI records for the device and packaging levels, plus the UDI-PI rules used for lot, serial, software, manufacturing, or expiry data on the label.
- Retain EUDAMED submission confirmations or exported records, label artwork, UDI carrier scans or proofs, notified-body alignment where relevant, and change assessments for each new or unchanged UDI-DI decision.

Sources for this answer:

- [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 retention of original product UDI for reprocessed devices and explains traceability expectations for supplied devices.
- [European Commission - EUDAMED UDI/device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Supports retaining EUDAMED UDI/device registration evidence and EMDN registration context.

### [What should the PMCF plan cover?](/artifacts/eu/medical-device-regulation/faq/pmcf.md#what-should-the-pmcf-plan-cover)

*Module: [What should an EU MDR PMCF plan and report cover?](/artifacts/eu/medical-device-regulation/faq/pmcf.md)*

PMCF is a continuous process that updates the clinical evaluation under Article 61 and Annex XIV, Part B. It must be addressed in the manufacturer's PMS plan and performed under a documented PMCF plan.

- Define general methods such as clinical experience review, user feedback, scientific literature screening, and other clinical-data sources.
- Define specific methods where needed, such as suitable registries, PMCF studies, real-world evidence analyses, healthcare-professional surveys, patient or user surveys, and case-report review.
- For each activity, state the source of the need, objective, rationale, known limitations, data quality expectations, endpoints or analysis approach, and justified schedule for analysis and reporting.
- Reference applicable common specifications, harmonised standards used by the manufacturer, and PMCF guidance where they support the plan.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Binding MDR source for Article 61, Article 83-86, Annex III, and Annex XIV Part B requirements on clinical evaluation, PMS, PMCF planning, PMCF reports, PSUR content, and technical documentation.
- [MDCG 2020-7 - PMCF plan template](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/a5cdb303-c782-4010-8723-7d389af678f7%5Fen?filename=md%5Fmdcg%5F2020%5F7%5Fguidance%5Fpmcf%5Fplan%5Ftemplate%5Fen.pdf&ref=sorena.io) - MDCG template source for PMCF plan sections, device description, PMCF methods and activities, links to the clinical evaluation report and risk management file, equivalent or similar device data, standards or guidance references, and report timing fields.

### [What evidence should be retained?](/artifacts/eu/medical-device-regulation/faq/pmcf.md#what-evidence-should-be-retained)

*Module: [What should an EU MDR PMCF plan and report cover?](/artifacts/eu/medical-device-regulation/faq/pmcf.md)*

Keep evidence showing that PMCF was planned, performed, analysed, and used to update the device file. The retained record should let a reviewer trace each PMCF activity from the clinical question or risk being monitored to the data source, method, result, conclusion, and follow-up action.

- Retain the PMCF plan, revision history, activity table, protocols, search strategies, registry or study summaries, survey instruments, case-review records, and analysis outputs.
- Retain the PMCF evaluation report with links to the clinical evaluation report, risk management file, PMS plan, PMS report or PSUR where applicable, and any preventive or corrective action records.
- Keep the rationale for method choice, sample size or data sufficiency, endpoints, comparator or state-of-the-art references, known limitations, missing-data handling, and acceptance criteria where used.
- If no PMCF activity is planned or an activity is limited, retain the MDR-grounded justification and the evidence showing why the residual clinical questions remain adequately controlled.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Binding MDR source for the requirement that PMCF findings are documented in a PMCF evaluation report, included in the clinical evaluation report and technical documentation, and considered for clinical evaluation, risk management, and preventive or corrective measures.
- [MDCG 2020-13 - clinical evaluation assessment report template](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en/document/download/02f50abc-91db-4ad9-b137-6ffedb690716%5Fen?filename=md%5F2020-13-cea-report-template%5Fen.pdf&ref=sorena.io) - MDCG template source showing notified-body review prompts for PMS plan, PMS report where relevant, PMCF plan, PMCF report where relevant, PSUR if available, and clinical-evaluation update planning.

### [How should manufacturers assess an MDR class change?](/artifacts/eu/medical-device-regulation/faq/class-changes.md#how-should-manufacturers-assess-an-mdr-class-change)

*Module: [What should manufacturers do when an EU MDR classification changes?](/artifacts/eu/medical-device-regulation/faq/class-changes.md)*

Start with the intended purpose as stated in labels, instructions for use, advertising, clinical documentation, and software release material. MDR classification is based on intended purpose and inherent risk, and Annex VIII applies the strictest applicable rule when more than one rule fits the device.

- Re-map the product against Annex VIII using the current intended purpose, device characteristics, duration, invasiveness, active-device status, substance or medicinal components, and software functions.
- Compare the new class with the existing declaration, notified-body certificate, Basic UDI-DI/device registration data, technical documentation, clinical evaluation, PMS/PMCF plans, labels, and instructions for use.
- If the device is a legacy device relying on MDR transitional provisions, assess whether the change is a significant change in design or intended purpose; significant changes can prevent continued reliance on the legacy route.
- Ask the notified body before implementation when the existing certificate, approved type, technical-documentation assessment, or surveillance arrangement may be affected.
- Do not publish new claims, indications, target populations, software outputs, or system/procedure-pack combinations until the classification rationale and conformity route have been updated.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - MDR source for intended purpose, Annex VIII classification, conformity assessment under Article 52, technical documentation, certificates, and manufacturer evidence duties.
- [Regulation (EU) 2023/607 on MDR and IVDR transitional provisions](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607&ref=sorena.io) - Supports the legacy-device warning that transitional placement conditions depend on no significant change in design or intended purpose and on notified-body application or agreement conditions where applicable.
- [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 explaining that notified bodies perform conformity-assessment tasks when third-party intervention is required.

### [What evidence should be retained for an MDR class-change review?](/artifacts/eu/medical-device-regulation/faq/class-changes.md#what-evidence-should-be-retained-for-an-mdr-class-change-review)

*Module: [What should manufacturers do when an EU MDR classification changes?](/artifacts/eu/medical-device-regulation/faq/class-changes.md)*

The evidence file should let a reviewer see why the old class is still valid or why the device needs a new conformity route. Keep the classification rationale with the technical documentation rather than as a separate project note.

- Intended-purpose evidence: current IFU, label, website and sales claims, clinical claims, target population, user setting, contraindications, and any planned claim changes.
- Rule evidence: Annex VIII rule mapping, rule conflicts resolved by the highest applicable class, software Rule 11 analysis, accessory or system/procedure-pack analysis, and rationale for exclusions.
- Route evidence: old and new conformity route, notified-body role, certificate/declaration status, Basic UDI-DI or device-registration impact, and affected technical-documentation sections.
- Change evidence: design, material, sterilisation, software, algorithm, data model, cybersecurity, integration, manufacturing, supplier, or intended-use changes reviewed for significance.
- Approval evidence: regulatory owner, quality approval, notified-body correspondence, open conditions, implementation hold/release decision, and post-market monitoring trigger.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - MDR source for keeping technical documentation up to date and retaining certificates, declarations, and technical documentation for competent authorities.
- [Regulation (EU) 2023/607 on MDR and IVDR transitional provisions](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607&ref=sorena.io) - Supports retaining evidence for legacy-device transition conditions, including significant-change assessment and notified-body agreement where relevant.

### [When clinical equivalence can support an MDR clinical evaluation](/artifacts/eu/medical-device-regulation/faq/equivalence.md#when-clinical-equivalence-can-support-an-mdr-clinical-evaluation)

*Module: [When can clinical equivalence be used under the EU MDR?](/artifacts/eu/medical-device-regulation/faq/equivalence.md)*

The MDR allows a clinical evaluation to rely on clinical data for another device only where equivalence to the device under evaluation can be demonstrated. This is not a shortcut around clinical evaluation: the clinical evaluation still has to be planned, continuously conducted, documented, and supported by a clinical evaluation report.

- Technical: compare design, conditions of use, specifications and properties, deployment methods, principles of operation, critical performance requirements, and software algorithms where relevant.
- Biological: compare the same materials or substances in contact with the same tissues or body fluids, including kind and duration of contact and release characteristics such as degradation products and leachables.
- Clinical: compare the same clinical condition or purpose, site in the body, similar population, same kind of user, and relevant critical performance for the expected clinical effect.
- Access: retain evidence that the manufacturer has sufficient access to the equivalent-device data needed to justify the equivalence claim.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Annex XIV supports the three equivalence characteristics, scientific-justification requirement, data-access requirement, clinical evaluation report, PMCF, and technical-documentation evidence.
- [MDCG 2020-5 - Clinical Evaluation - Equivalence](https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.pdf?ref=sorena.io) - MDCG 2020-5 explains how manufacturers and notified bodies should demonstrate equivalence under the MDR, including comparison tables, data access, class III and implantable-device limits, and use of similar-device data.

### [Class III and implantable-device limits](/artifacts/eu/medical-device-regulation/faq/equivalence.md#class-iii-and-implantable-device-limits)

*Module: [When can clinical equivalence be used under the EU MDR?](/artifacts/eu/medical-device-regulation/faq/equivalence.md)*

For implantable devices and class III devices, MDR equivalence is more constrained. MDCG 2020-5 explains that clinical investigations are generally expected unless the device is a modification of a device already marketed by the same manufacturer and equivalence is demonstrated under the MDR.

- Do not use a competitor equivalence claim for a class III or implantable device unless the access-to-technical-documentation requirement is actually met.
- For high-risk devices, check whether the claim is based on a same-manufacturer modification or on another manufacturer's device, because the access route and limits differ.
- For devices other than implantable and class III devices, still document sufficient access to the data used for the equivalence claim.

Sources for this answer:

- [MDCG 2020-5 - Clinical Evaluation - Equivalence](https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.pdf?ref=sorena.io) - The guidance gives the class III and implantable-device limits for equivalence, including same-manufacturer modification and full ongoing technical-documentation access for another manufacturer's device.
- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Article 61 and Annex XIV provide the MDR basis for clinical evaluation, equivalence, and access to data relating to devices claimed as equivalent.

### [How equivalence connects to PMCF](/artifacts/eu/medical-device-regulation/faq/equivalence.md#how-equivalence-connects-to-pmcf)

*Module: [When can clinical equivalence be used under the EU MDR?](/artifacts/eu/medical-device-regulation/faq/equivalence.md)*

Equivalence evidence should remain connected to the clinical evaluation and PMCF plan. MDR Annex XIV treats PMCF as the continuous process that updates the clinical evaluation, confirms safety and performance over the device lifetime, checks the benefit-risk ratio, and detects emerging risks on factual evidence.

- Link the equivalence table to the clinical evaluation report and PMCF plan.
- Keep PMCF objectives specific to the device's intended purpose, clinical claims, known risks, and evidence gaps.
- Use similar-device data for state of the art, risk signals, outcome parameters, PMCF design, or clinical-investigation design when equivalence cannot be demonstrated.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Annex XIV Part B establishes PMCF as a continuous process that updates clinical evaluation and requires a documented PMCF plan and PMCF evaluation report.
- [MDCG 2020-5 - Clinical Evaluation - Equivalence](https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.pdf?ref=sorena.io) - MDCG 2020-5 distinguishes demonstrated equivalence from broader similar-device data that may inform risk management, state of the art, PMCF design, and clinical-investigation design.

### [Evidence to retain](/artifacts/eu/medical-device-regulation/faq/equivalence.md#evidence-to-retain)

*Module: [When can clinical equivalence be used under the EU MDR?](/artifacts/eu/medical-device-regulation/faq/equivalence.md)*

Retain a reviewer-ready record showing which device was assessed, which presumed equivalent device was used, what data were available, and why the manufacturer concluded that the MDR equivalence criteria were met. The record should sit with the clinical evaluation report and technical documentation, not in an informal rationale detached from the conformity-assessment file.

- Device identity, intended purpose, clinical condition, target population, user type, site in the body, and relevant critical performance claims.
- Technical comparison for design, conditions of use, specifications, software algorithms, deployment methods, principles of operation, and critical performance requirements.
- Biological comparison for materials or substances, body contact, contact duration, release characteristics, degradation products, and leachables.
- Evidence of access to equivalent-device data, including technical documentation access where the MDR route requires it.
- Clinical evaluation report, PMCF plan, PMCF evaluation reports, favourable and unfavourable clinical data considered, and any risk-management or corrective-action updates.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - The MDR requires the clinical evaluation results, clinical evidence, favourable and unfavourable data, PMCF outputs, and supporting documentation to be documented in the clinical evaluation report and technical documentation.
- [MDCG 2020-5 - Clinical Evaluation - Equivalence](https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.pdf?ref=sorena.io) - MDCG 2020-5 provides an equivalence-table structure for documenting technical, biological, and clinical comparisons and scientific justifications.

### [When does a claim create MDR medical-device scope?](/artifacts/eu/medical-device-regulation/faq/medical-purpose-claims.md#when-does-a-claim-create-mdr-medical-device-scope)

*Module: [When do software or products make medical purpose claims under the EU MDR?](/artifacts/eu/medical-device-regulation/faq/medical-purpose-claims.md)*

A product, including software, is within the MDR device definition when the manufacturer intends it to be used for one or more MDR medical purposes for human beings. Core medical-purpose language includes diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease, injury, or disability; investigation, replacement, or modification of anatomy or a physiological or pathological process or state; and certain in vitro information uses.

- Treat phrases such as diagnose, predict, monitor, treat, triage, detect, screen, clinical decision support, therapy recommendation, or patient-specific risk score as MDR qualification triggers to assess, not as copy-only choices.
- Review the live claim set across packaging, app-store text, website pages, sales decks, manuals, onboarding screens, demo scripts, support articles, and clinical evaluation material.
- If the intended use changes from wellness, administration, or information transfer into patient-specific medical information or device control, reopen the qualification and classification rationale.

Sources for this answer:

- [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj?ref=sorena.io) - Defines medical devices, intended purpose, labels, instructions for use, and prohibited misleading claims.

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*Recommended next step for EU MDR teams*

*Placement: after implementation section*

## Resolve MDR scope and evidence questions with citations

Use the FAQ as a starting point for product-specific MDR qualification, classification, clinical evidence, UDI, EUDAMED, and transition records.

- [Open Research Copilot](/solutions/research-copilot.md): Answer MDR interpretation questions with cited source material.
- [Talk through implementation](/contact.md): Review your device scope, evidence model, and next MDR actions.


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