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Legacy & grandfathered devices

Regulatory basis

MDR Art. 120 (transitional provisions for MDD/AIMDD devices); IVDR Art. 110 (transitional provisions for IVDD devices); Regulation (EU) 2023/607 (amended MDR transitional dates); Regulation (EU) 2024/1860 (amended IVDR transitional dates).

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice. Transitional timelines have been amended multiple times — always verify current deadlines in the Official Journal of the EU.

What is a legacy device?​

A legacy device is a medical device or IVD that was lawfully CE marked under the old directives (MDD, AIMDD, IVDD) before the application of MDR/IVDR, and which continues to be sold under the transitional provisions while the manufacturer works toward MDR/IVDR certification.

The transition from directives to regulations created a practical challenge: manufacturers needed time to generate the additional evidence and documentation required by MDR/IVDR, while keeping established products on the market. Transitional provisions allow continued sale of MDD/IVDD-certified devices under defined conditions and for defined periods.

MDR transitional provisions — Art. 120 (as amended)​

Original MDR application date​

MDR applied from 26 May 2021.

MDD/AIMDD certificates — continued validity (as amended by Regulation 2023/607)​

MDD and AIMDD certificates issued before 26 May 2021 can remain valid until their expiry date, subject to:

Device classMaximum continued validity (certificates not expired by 26 May 2024)
Class III and Class IIb implantableUntil 31 December 2027
Class IIb (non-implantable) and Class IIaUntil 31 December 2028
Class I (MDD)No certificate needed — but MDR compliant from 26 May 2021

These extended dates apply provided:

  1. The device continues to comply with MDD/AIMDD
  2. The device has not undergone significant change in design or intended purpose
  3. The manufacturer has signed a formal agreement with an MDR-notified body
  4. The manufacturer has submitted a formal MDR application to the NB by specific dates set out in the regulation

"Sell-through" provision​

After the transitional certificate expires, devices manufactured and CE marked under MDD/AIMDD before that date may continue to be placed on the market until 31 December 2028 or 31 December 2029 (depending on class) — the sell-through allows products already in stock to be sold.

IVDR transitional provisions — Art. 110 (as amended)​

IVDR applied from 26 May 2022 for Class D and progressively later for other classes.

IVDD certificates — continued validity (as amended by Regulation 2024/1860)​

IVDR ClassIVDD certificate continued validity
Class DUntil 31 December 2027
Class CUntil 31 December 2028
Class BUntil 31 December 2029
Class A (non-sterile) self-declaredUntil 31 December 2030

Conditions mirror those for MDR: continued compliance with IVDD; no significant change; NB agreement and application submitted by specified dates.

Self-certified IVDD devices (general devices)​

Under IVDD, the vast majority of IVDs were self-certified. These devices have no expiring notified body certificate but must transition to IVDR (and where required, obtain NB certification) by the applicable deadline for their IVDR class.

Conditions for continued marketing of legacy devices​

A manufacturer wishing to continue marketing a legacy device under transitional provisions must:

  1. Continue to comply with MDD/AIMDD/IVDD — the device must remain in compliance with the original directive requirements throughout the transition period
  2. No significant change — the device design, labelling, or intended purpose must not have changed significantly (change triggers immediate MDR/IVDR compliance obligation)
  3. Active MDR/IVDR application in progress — the manufacturer must have a concrete plan and (by specified dates) a signed agreement with an MDR/IVDR-designated NB
  4. Post-market surveillance — the manufacturer must continue PMS under MDD/AIMDD/IVDD and is subject to vigilance reporting obligations under MDR/IVDR even for transitional devices

Clinical evidence challenge for legacy devices​

One of the most significant challenges for legacy devices transitioning to MDR is the clinical evidence requirement. Many devices that were certified under MDD on the basis of general literature or older clinical data now need to demonstrate compliance with MDR Art. 61's more stringent clinical evaluation requirements.

MDCG 2021-6 specifically addresses the challenge of demonstrating sufficient clinical evidence for legacy devices, providing guidance on:

  • Acceptable evidence from equivalence claims for legacy devices of the same manufacturer
  • What post-market data (complaint records, vigilance, registry data) can contribute to the clinical evaluation
  • When new clinical investigation data will be required

Implications for economic operators​

  • Manufacturers: must prioritise which products to transition (commercial analysis), engage NBs early, and build MDR-compliant technical documentation in parallel with continued MDD sales
  • Importers and distributors: must understand whether products they handle are transitional legacy devices and the conditions under which they can continue to be sold
  • Healthcare institutions: should be aware of the transitional status of devices in their inventory and procurement

Official references​

ReferenceDescription
MDR Art. 120MDR transitional provisions
IVDR Art. 110IVDR transitional provisions
Regulation (EU) 2023/607Amendment to MDR transitional dates
Regulation (EU) 2024/1860Amendment to IVDR transitional dates
MDCG 2021-6Clinical evidence for legacy devices
MDCG 2022-14Transitional provisions guidance