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EU MDR Legacy Device Transition — Final Deadlines and Action Plan

Regulatory & Compliance

EU MDR Article 120 Legacy Device Transition — Final Deadline Guide

Turkish Medical Index 10 September 2026 turkishmedicalindex.com
Overview: EU MDR Article 120 provided a transitional pathway for devices that held valid CE certificates under the old MDD/AIMDD directives. Multiple deadline extensions have been granted since MDR became applicable in May 2021, but the final transition deadlines are now firmly in place and cannot be assumed to extend further. This guide clarifies exactly which devices are still covered by transitional provisions, what the remaining deadlines are, and what Turkish manufacturers must do to maintain market access.

What Is Article 120 and Why Does It Matter?

EU MDR Article 120 created a transitional pathway allowing devices CE-certified under the MDD (93/42/EEC) or AIMDD (90/385/EEC) directives to continue being placed on the EU market for a defined period after May 2021, without requiring immediate full MDR certification. This was critical for manufacturers who could not complete their MDR transition before the original deadline.

Following COVID-19 delays and Notified Body capacity constraints, the EU extended these transitional provisions twice — most recently through Regulation (EU) 2023/607. The final deadlines established by this regulation are not expected to be extended again.

Final Article 120 Transitional Deadlines

Device Risk ClassFinal Sell-By / Continued Use Deadline
Class III implantables (MDD) and all AIMDD devices31 December 2027
Class IIb implantable MDD devices (excl. sutures, staples, dental fillings, screws/plates/wires, items in contact <30 days)31 December 2027
All other Class IIb and Class IIa MDD devices31 December 2028
Class I MDD devices (in original or modified configuration)31 December 2028

Note: Devices already placed on the market under transitional provisions may continue to be used by healthcare institutions beyond these dates — the deadlines apply to placing on the market (new shipments), not to use of already-delivered devices.

Critical Conditions for Article 120 Transitional Use

Article 120 transitional provisions only apply when ALL of the following conditions are continuously met:

  • The MDD CE certificate was valid on 25 May 2017 (MDR entry into force date) — not just at application in 2021
  • The Notified Body that issued the original MDD certificate is still designated and notified under MDR
  • The device and its manufacturing have not undergone significant changes that would constitute a new device or new indication
  • A written agreement exists between the manufacturer and a designated MDR Notified Body for transition of the device
  • The manufacturer has a compliant ISO 13485 QMS and is actively implementing MDR PMS requirements

If any of these conditions fail, the transitional provision is immediately invalid — the device can no longer be placed on the EU market.

What Actions Are Required Now

Immediate Actions
  • Audit all MDD CE certificates — confirm which Notified Bodies issued them and whether those NBs are still MDR-notified
  • Confirm written NB agreement for MDR transition exists for every transitional device
  • Assess which devices are within transitional deadline scope
  • Prioritise MDR Technical Documentation completion for highest-revenue transitional devices
2026–2027 Milestones
  • Complete MDR-compliant Technical Documentation (Annex II/III) for Class IIb/III devices by Q2 2027
  • Submit MDR conformity assessment application to NB by Q3 2027 at latest for Class IIb/III
  • Class IIa and Class I MDR transition: complete by Q2 2028
  • EUDAMED registration: update all device records from MDD to MDR classification

Common Article 120 Compliance Mistakes

  • Assuming another extension will come: Regulation (EU) 2023/607 sets these dates in law, and the Commission's December 2025 proposal to revise the MDR had not changed them as of October 2026 — plan as if they are final
  • NB relationship assumption: Several Notified Bodies lost their MDR designation post-2021 — if your original MDD NB is no longer designated, your transitional provision may already be invalid
  • Significant change during transition: Changing a device's materials, software, intended use, or manufacturing process may constitute a 'significant change' invalidating transitional status — always check with your QA/RA team before any product update
  • Ignoring EUDAMED migration: Devices under Article 120 must still be registered in EUDAMED as legacy devices — failure to migrate EUDAMED records is a compliance gap
  • Forgetting PMS obligations: Transitional devices are subject to MDR post-market surveillance requirements now, not at the end of transition
The Article 120 transitional period is ending. Turkish medical device manufacturers must treat the 31 December 2027 (Class IIb/III implantables) and 31 December 2028 (all others) deadlines as fixed commercial planning constraints. The EU's legislative message is clear: the MDR transition window is closing, and no manufacturer should be building business plans around assumptions of further extension. The cost of losing EU market access mid-year due to a missed transitional deadline — in revenue, distributor relationships, and brand damage — far exceeds the cost of an accelerated MDR certification investment.