Glossary Updates12 new terms added to the glossaries · October 2, 2026, 22:44 CEST
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Glossary · EU medical devices: MDR

Transition periods (MDR and IVDR)

Also known as: Legacy devices, Article 120 MDR, Article 110 IVDR, MDR extension (Regulation (EU) 2023/607)

Under the EU Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, the transition periods allow legacy devices covered by certificates or declarations under the former directives to be placed on the market for a limited time after the regulations became applicable, provided set conditions are met. As amended by Regulations (EU) 2023/607 and 2024/1860, they run until December 31, 2027, 2028 or 2029, depending on the risk class.

  • EU
  • MDR
  • IVDR

In one sentence

MDR and IVDR transition periods: legacy devices may stay on the market until 2027, 2028 or 2029 by class, if QMS, application and no-change conditions are met.

Example

A manufacturer of a class IIa ultrasound gel under a valid Directive certificate continues to place it on the market after May 2024 because it had an MDR quality management system, applied to a notified body by May 26, 2024 and signed a written agreement by September 26, 2024.

How it applies

  • MDR dates: December 31, 2027 for class III and class IIb implantable devices (with exceptions); December 31, 2028 for other class IIb, class IIa, class I sterile, measuring or reusable surgical devices and devices up-classified from class I.
  • MDR conditions: A quality management system under Article 10(9) by May 26, 2024; a formal application to a notified body by May 26, 2024 and a written agreement by September 26, 2024; no significant changes in design or intended purpose. The sell-off deadline was deleted.
  • IVDR dates: December 31, 2027 for class D, December 31, 2028 for class C and December 31, 2029 for class B and sterile class A. Conditions include a QMS by May 26, 2025 and applications to a notified body by May 26, 2025 (class D), May 26, 2026 (class C) and May 26, 2027 (class B and sterile class A).
  • What still applies: Legacy devices must already meet the regulations’ requirements on post-market surveillance, market surveillance, vigilance and registration.
  • Supply interruptions: Regulation (EU) 2024/1860 added Article 10a: since January 10, 2025, manufacturers inform the competent authority and operators, as a rule at least six months in advance, of an anticipated interruption or discontinuation of supply of certain devices where this could cause serious harm.
  • Technical documentation: Keep evidence of each condition (QMS certificate, application, signed agreement) and a change log showing no significant change. Plan the transfer of the technical documentation to the MDR or IVDR structure well before the end date.

Significant change vs. substantial modification

A “significant change in design or intended purpose” ends a legacy device’s transition status under the MDR and IVDR; MDCG guidance explains what counts. The substantial modification concept in machinery and AI law is a different test with different consequences. Don’t reuse one assessment for the other.