FAQEU

EU MDR FAQ Significant Changes

Significant-change screening matters most for MDR legacy devices that still rely on AIMDD or MDD certificates, declarations, and transition conditions.

Use this FAQ to decide when a design, intended-purpose, software, material, sterilisation, clinical, or QMS change needs escalation before release.

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Author
Sorena AI
Published
May 9, 2026
Updated
May 9, 2026
Questions
3

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Primary sources
3

Cited legal and guidance references.

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Sorena AI
Published May 9, 2026
Updated May 9, 2026
Overview

Under MDR Article 120 transition rules, a legacy device can keep relying on the transition route only if the Article 120 conditions are met, including no significant change in design or intended purpose. Screen the change before release, involve the notified body when the AIMDD/MDD certificate or approved QMS route requires it, and retain the evidence showing why the change is significant, non-significant, or outside the Article 120 significant-change question.

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3 of 3 questions
Question 1

Which MDR changes need significant-change screening?

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.

Screen intended-purpose changes, design or performance specification changes, software changes, substance and material changes, and sterilisation or sterile-packaging changes. Administrative changes, manufacturing-site moves, supplier changes that keep the same specification, and some QMS or process changes may be outside design or intended purpose, but they still need documentation and any agreed notified-body notification.

  • 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.
Citations
Question 2

What is the notified-body and certificate impact?

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.

Regulation (EU) 2023/607 also ties the transition route to continued compliance with AIMDD/MDD, absence of significant design or intended-purpose changes, no unacceptable risk, a QMS under MDR Article 10(9), formal MDR conformity-assessment application, written agreement with a notified body, and transfer or continuation of appropriate surveillance as applicable.

  • 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.
Citations
Recommended next step

Review MDR change impact before release

Use this FAQ to prepare a concise significant-change record before approving a design, software, material, sterilisation, QMS, label, or clinical-evidence change for an MDR legacy device.

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Question 3

What evidence should be retained?

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.

For clinical and technical impact, update the technical documentation, risk management file, clinical evaluation or PMCF rationale, verification and validation evidence, usability evidence, supplier/material specifications, sterilisation validation, labels and IFU, PMS or vigilance inputs, and QMS change-control records as applicable.

  • 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.
Citations
Primary sources

References and citations

Regulation (EU) 2017/745 on medical devices
eur-lex.europa.eu
Referenced sections
  • MDR source for keeping technical documentation up to date, QMS change control, clinical evaluation, PMCF, and documentation retention.
"draw up and keep up to date technical documentation"
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