Regulation (EU) 2023/607 amended MDR Article 120 so certain MDD and AIMDD legacy devices can keep being placed on the market or put into service only when the transition conditions are met.
This page helps check certificate status, class-based transition dates, QMS and notified-body milestones, significant-change limits, surveillance duties, and the evidence file a reviewer should expect.
A transition under the EU MDR is not a broad grace period. The Article 120 extension depends on a device-by-device record showing the earlier directive basis, certificate or declaration status, continued or compliance, no significant design or intended-purpose change, no unacceptable health or safety risk, MDR QMS readiness, a timely notified-body application, and a written agreement where required.
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Section 1
Transition conditions to verify first
Start with the exact device and certificate history. Regulation (EU) 2023/607 extended Article 120 for devices covered by valid or certificates and for certain former class I MDD devices that now require notified-body involvement under the MDR, but the extension is conditional.
For certified devices, Article 120(3a) points to 31 December 2027 for class III devices and class IIb implantable devices other than the listed low-risk implantable exceptions. It points to 31 December 2028 for other class IIb devices, class IIa devices, and class I devices placed on the market in sterile condition or with a measuring function. Article 120(3b) also uses 31 December 2028 for qualifying former class I devices whose MDD declaration of conformity was drawn up before 26 May 2021 and whose MDR conformity route now needs a notified body.
The date is usable only if Article 120(3c) is satisfied: continued or compliance, no significant change in design or intended purpose, no unacceptable risk, an MDR Article 10(9) quality management system by 26 May 2024, a formal conformity-assessment application by 26 May 2024, and a written agreement with the notified body by 26 September 2024.
Class III custom-made implantable devices do not use the certificate-based 2027 or 2028 groups. Article 120(3f) gave them a separate route to 26 May 2026, subject to an Annex XIII section 2 application by 26 May 2024, a written agreement by 26 September 2024, and an Article 52(8) certificate by 26 May 2026. A device that missed those milestones needs another lawful MDR basis.
Create a device list that ties each to its or certificate, declaration of conformity, risk class, intended purpose, and substitute-device strategy if any.
For certificates that expired before 20 March 2023, record whether the pre-expiry written agreement route, an Article 59 derogation, or an Article 97 conformity-assessment requirement supports continued validity.
Do not treat the transition date as available if the manufacturer has no MDR QMS, no timely application, no written agreement where required, or a change record that alters design or intended purpose in a significant way.
Turn the legacy transition file into reviewable evidence
Use the transition checklist to assemble certificate history, Article 120 eligibility, QMS proof, notified-body agreements, change-control decisions, PMS, vigilance, and clinical evidence in one reviewable record.
Certificate validity, applications, and surveillance
A legacy certificate is not enough by itself. The record should show that it was issued under Directive 90/385/EEC or Directive 93/42/EEC from 25 May 2017, was valid on 26 May 2021, and was not withdrawn afterwards. If it expired before 20 March 2023, continued validity depends on one of the specific Article 120(2) routes: a manufacturer-notified body written agreement signed before expiry, or a competent-authority derogation or Article 97 procedure that covers the device.
After the Article 120(3c) deadlines, the practical center of gravity moves to the MDR notified body. Article 120(3e) keeps the issuing notified body responsible for appropriate surveillance until the manufacturer has agreed surveillance with an MDR-designated notified body; by 26 September 2024 the notified body that signed the written agreement is responsible for surveillance for devices covered by that agreement.
The surveillance transfer should be documented rather than assumed. Keep the old certificate, the formal application, the written agreement, the device scope covered by the agreement, surveillance-transfer arrangements, and any confirmation letters or written notified-body decisions together in the transition file.
Match certificate scope to actual model names, variants, Basic UDI-DI or device identifiers where available, intended purpose, and the device intended to substitute the if the application uses a substitute route.
Keep evidence that the notified body can add submitted information to its files; a read-only platform link is weak evidence if it does not allow the notified body to retain the relevant documents.
Track notified-body written decisions separately from certificates, because non-significant administrative corrections or additions do not create a new or certificate.
The transition file needs a change-control gate. Article 120(3c) requires no significant change in design or intended purpose. MDCG 2020-3 Rev.1 explains that this assessment is case-specific and concerns legacy devices using the amended Article 120 transition.
Changes to intended purpose, patient or user population, clinical use, design or performance specifications, software, materials, substances, sterilisation method, or packaging design affecting sterilisation need explicit significance review. A change can also be significant when it creates new risks, negatively affects existing risks, changes control mechanisms, changes operating principles, changes energy sources, or changes alarms.
Administrative changes and some QMS or manufacturing-site changes may be non-significant when they do not affect design or intended purpose and the certification conditions remain maintained, but they still belong in the change notification process agreed with the notified body. When in doubt, the manufacturer should ask the notified body and keep the answer with the certificate package.
Use a change assessment form with fields for intended purpose, clinical claims, design/performance specifications, software, materials, sterilisation, risk controls, usability or clinical data impact, and notified-body notification result.
For non-significant changes, keep the rationale, supporting design or risk evidence, notified-body confirmation where applicable, and a statement that the certificate itself was not amended or supplemented.
For significant changes, treat the changed device as outside the legacy transition path and plan MDR conformity assessment before placing that changed device on the market.
Legacy status does not freeze every obligation under the old directives. Article 120(3d) applies MDR requirements for post-market surveillance, market surveillance, vigilance, registration of economic operators, and device registration to Article 120(3a) and 120(3b) devices in place of the corresponding or requirements. Commission Q&A separately states that legacy devices are not subject to MDR UDI requirements during the extended transition.
The transition evidence should therefore connect Article 120 eligibility to live MDR operating controls: PMS plan and report routines, PMCF decisions where relevant, complaint and incident intake, vigilance evaluation, field safety corrective action handling, registration data, QMS procedures, and management review of unresolved transition gaps.
For clinical evidence, legacy-device status does not mean old clinical files are automatically sufficient for MDR certification. MDCG 2020-6 treats clinical evaluation as a lifecycle activity and expects PMS and PMCF data to feed the clinical evaluation for legacy devices.
Keep a PMS-to-clinical-evaluation trace showing how complaints, incidents, PMCF, literature, registries, and benefit-risk conclusions are reviewed for the .
Maintain vigilance and field safety records with the same device identity used in the certificate, technical documentation, PMS plan, and registration data.
Use the QMS file to prove the 26 May 2024 Article 10(9) condition and to show transition governance, change control, supplier controls, complaint handling, CAPA, and management responsibility.
A useful transition pack should let a regulatory, quality, procurement, or authority reviewer see why the device can still be supplied and what work remains for MDR certification. Keep it short enough to review, but complete enough to prove each Article 120 condition without relying on project memory.
Separate the legal eligibility record from operational evidence. The eligibility record answers whether the transition is available; the operational evidence proves PMS, vigilance, registration, QMS, surveillance, and change-control obligations are still running.
Eligibility record: device identity, directive certificate or declaration, certificate validity path, class-based transition date, Article 120(3c) condition checklist, and substitute-device mapping if used.
Notified-body record: formal application, written agreement, surveillance-transfer arrangement, certificate scope mapping, confirmation letters, written decisions, open nonconformities, and agreed milestones.
Change-control record: all design, intended-purpose, software, material, sterilisation, supplier, QMS, labelling, and clinical-claim changes with significance rationale and notified-body handling.
Operational record: Article 10(9) QMS evidence, PMS plan and outputs, PMCF rationale or plan, vigilance reports, complaints and CAPA, registration data, technical documentation gap plan, and management-review actions.