EU MDR Legacy Device Transition

Start with the exact device and certificate history. Regulation (EU) 2023/607 extended Article 120 for devices covered by valid AIMDD or MDD 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 MDD 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 AIMDD or MDD 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.

A legacy certificate is not enough by itself. The file should show that the certificate was issued under Directive 90/385/EEC or Directive 93/42/EEC from 25 May 2017, was still valid on 26 May 2021, and was not withdrawn afterwards, or that an expired-before-20-March-2023 certificate fits one of the Article 120(2) rescue routes.

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.

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.

Legacy status does not freeze the device under the old directives for every obligation. 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 AIMDD or MDD requirements.

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.

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.