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EU Medtech

EU MDR transition deadlines: 2027 & 2028 timeline by device class

Under Regulation (EU) 2023/607, the EU Medical Device Regulation transition runs to 31 December 2027 for Class III and Class IIb implantable devices and 31 December 2028 for other Class IIb, Class IIa and Class I devices — provided manufacturers met the 2024 notified-body application milestones.

Next deadline: 31 December 2027 · 543 days

Deadline timeline

  1. MDR date of application · passed

    Regulation (EU) 2017/745 (MDR) becomes applicable, replacing the MDD/AIMDD.

    Applies to: All medical devices on the EU market

    Source ↗

  2. Notified-body application · passed

    Deadline to lodge a formal conformity-assessment application with a notified body to keep the extended transition.

    Applies to: Legacy-device manufacturers

    Source ↗

  3. Written agreement signed · passed

    Deadline for a signed written agreement between manufacturer and notified body.

    Applies to: Legacy-device manufacturers

    Source ↗

  4. Class III & IIb implantable

    Extended transition ends for Class III and Class IIb implantable devices (with limited exceptions such as sutures, staples, dental fillings).

    Applies to: Class III and IIb implantable devices

    Source ↗

  5. Class IIb, IIa, I

    Extended transition ends for other Class IIb, Class IIa, Class Is/Im and up-classified Class I devices.

    Applies to: Class IIb (other), IIa, and I devices

    Source ↗

Who’s in scope

  • Legacy devices certified under the MDD/AIMDD still being placed on the EU market under the Article 120 transition
  • Manufacturers who met the May/September 2024 notified-body milestones

Exclusions

  • Devices that did not meet the 2024 notified-body application and agreement milestones lose the extended transition
  • IVDs are governed by the separate IVDR transition timeline, not this one

The MDR transition was extended by Regulation (EU) 2023/607, and the deadlines now run by device risk class — provided a manufacturer met the gating milestones in 2024 (a notified-body application by 26 May 2024 and a signed agreement by 26 September 2024). Miss those, and the extended transition does not apply.

For manufacturers still inside the transition, two dates matter. 31 December 2027 ends the transition for Class III and Class IIb implantable devices, with narrow exceptions for items like sutures, staples, and dental fillings. 31 December 2028 ends it for other Class IIb, Class IIa, and Class I devices. Regulation 2023/607 also removed the MDR/IVDR sell-off period, so compliant legacy stock can remain on the market without a fixed end date beyond its own shelf life.

The operational bottleneck is rarely the legal text — it is notified-body capacity and the evidence reassembly needed to move a legacy technical file onto MDR’s heavier clinical-evidence and post-market-surveillance requirements. Treat the class deadline as the date your notified-body certificate must be issued by, and work backwards from the queue, not the calendar.

Last reviewed . Deadlines change — always confirm against the cited primary source.