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EU MDR workflowChange control

EU MDR change assessment workflow

Review 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 involvement is needed, and what evidence is retained.

Back to main artifactReview sources
Author
Sorena AI
Published
May 9, 2026
Updated
Oct 15, 2026
5 sections7 primary sources
Overview

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 apply the Article 120 significant-change test for a legacy device or the applicable conformity-route change controls for an MDR-certified device, and decide whether the device can proceed under the existing conformity position or needs review, certificate action, or a new MDR conformity assessment step.

Section 1

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 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.
Section 2

2. Decide whether the change is significant

Treat significance as a documented technical and regulatory judgement. MDCG 2020-3 Rev.1 is guidance for relying on the Article 120 transition; it is not the change-approval procedure for an MDR-certified device. For a legacy device, first ask whether the change concerns design or intended purpose, then apply the relevant intended-purpose, design, software, substance/material, and sterilisation questions. If any applicable branch reaches , do not release the changed device in reliance on that transition.

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 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.
Section 3

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, subject to the limited role for sterile devices, measuring devices, and reusable surgical instruments. Class IIa, IIb, and III devices require notified-body involvement. For an MDR-certified device, follow the applicable Annex IX, X, or XI change provision and the notified-body contract: substantial QMS or device-range changes and changes that could affect an approved device's safety, performance, or conditions of use may require assessment, a certificate supplement, or a new conformity assessment.

  • 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 certificate scope, and whether the applicable procedure requires notification, prior approval, a certificate supplement, or a new conformity assessment. Restriction, suspension, or withdrawal is a decision, not an outcome the manufacturer selects in the change record.
  • output: the submitted change package, notified-body decision or written confirmation, assessment report or supplementary report where applicable, and unresolved nonconformities or conditions.
Section 4

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.
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Section 5

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, correspondence, updated file list, residual assumptions, and final release or escalation approval together.

For , 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 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 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 route, insufficient clinical or verification evidence, unresolved PMS/vigilance impact, or missing UDI traceability decision.
Primary sources

References and citations

MDCG 2020-3 Rev.1 on significant changes under Article 120 MDR
health.ec.europa.eu4 citations
Referenced sections
  • MDCG guidance source for screening significant design and intended-purpose changes, including software, materials, sterilisation, administrative, and manufacturing-change examples.
  • Grounds the change categories used here: intended purpose, design, software, substances or materials, sterilisation, administrative and manufacturing changes, and case-by-case evidence.
  • Supports the significant-change screening categories and examples for intended purpose, design, software, materials, and sterilisation.
Show 1 more
  • Supports documenting the outcome and making the manufacturer evidence available when a competent authority requests it.
"significant changes in the design or intended purpose"
More quoted passages
"assessed case-by-case"
"outcome of the assessment should be documented"
Regulation (EU) 2017/745 on medical devices
eur-lex.europa.eu4 citations
Referenced sections
  • Primary MDR source for classification, conformity assessment, technical documentation, clinical evaluation, PMS, UDI, notified-body procedures, and certificate change controls.
  • Grounds MDR classification rules, conformity assessment routes, notified-body role, technical documentation, clinical evaluation, PMS, UDI, and certificate change controls.
  • Supports updating technical documentation, risk management, clinical evaluation, PMS, PMCF, conformity evidence, and UDI records after a device change.
Show 1 more
  • Article 10(9) requires the manufacturer's quality management system to address procedures for managing modifications to devices covered by the system.
"classification rules"
More quoted passages
"update any relevant part of technical documentation"
"procedures for management of modifications to the devices covered by the system"
European Commission - EUDAMED UDI/device registration
health.ec.europa.eu2 citations
Referenced sections
  • Commission source for checking whether changed UDI/device information must be submitted in EUDAMED.
  • Supports checking whether changed UDI/device information must be reflected in EUDAMED registration data.
"UDI/Device information"
More quoted passages
"submit in EUDAMED the UDI/Device information"
European Commission notified bodies overview
health.ec.europa.eu2 citations
Referenced sections
  • Commission source for the role of notified bodies in conformity assessment when third-party intervention is required.
  • Supports the role of notified bodies when third-party conformity assessment is required for medical devices.
"conformity assessment procedures"
More quoted passages
"third-party intervention is required"
MDCG 2019-11 Rev.1 on software qualification and classification
health.ec.europa.eu2 citations
Referenced sections
  • MDCG source for reassessing medical device software qualification, classification, intended purpose, and combination-device impact after software changes.
  • Supports reassessing software qualification, classification, intended purpose, and combination-device impact when medical device software is changed.
"potential impact of any changes"
MDCG 2022-7 - UDI system Q&A
health.ec.europa.eu2 citations
Referenced sections
  • 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.
  • 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.
"misidentification of the device"
Regulation (EU) 2023/607 on MDR transitional provisions
eur-lex.europa.eu2 citations
Referenced sections
  • 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.
  • 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.
"no significant changes in the design and intended purpose"

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