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Transitional provisions & timelines

Applies to

MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746)

Disclaimer

Transitional provisions have been amended multiple times. Always verify current deadlines against the official regulation text and any subsequent amending regulations. This page reflects the position as amended by Regulation (EU) 2023/607 (MDR) and Regulation (EU) 2022/112 and 2023/607 (IVDR).

Overview​

Both MDR and IVDR replaced the previous Directive-era framework but provided transitional periods allowing devices already certified under MDD, AIMDD, or IVDD to remain on the market while manufacturers completed MDR/IVDR conformity assessments. These transitional periods have been extended multiple times due to notified body capacity constraints and the volume of devices requiring recertification.

MDR transitional provisions​

Dates of application​

EventDate
MDR published in Official Journal5 May 2017
Original date of application26 May 2020
Delayed date of application (COVID-19)26 May 2021
MDR fully applicable from26 May 2021

MDD/AIMDD certificates — sell-off provisions​

Regulation (EU) 2023/607 (the "MDR Extension Regulation") significantly extended the transitional provisions for MDD and AIMDD certified devices:

Device classExtended deadline for MDD/AIMDD certificate validityCondition
Class III and Class IIb implantablesUntil 31 December 2027Certificate valid on 26 May 2021; not withdrawn; MDR application submitted to NB by 26 May 2024
Class IIb non-implantable, Class IIa, Class I sterile/measuringUntil 31 December 2028Same conditions

For devices that have a valid MDR application with a notified body submitted by 26 May 2024, sell-off provisions extend further:

  • Devices placed on the market before the certificate expiry date may continue to be made available until 31 December 2028 (Class III / IIb implantables) or 31 December 2029 (other classes), provided:
    • The device remains safe
    • There are no significant changes in design or intended purpose
    • The manufacturer has informed the competent authority

Class I devices​

Class I devices that were self-certified under MDD and remain Class I under MDR require:

  • A new EU Declaration of Conformity under MDR
  • Updated technical documentation meeting MDR Annex II requirements
  • EUDAMED registration

No MDD certificate existed for Class I devices, so the certificate-based transitional provisions do not apply. Class I manufacturers needed to transition their DoC by 26 May 2021.

New devices and devices without MDD certification​

Any device that:

  • Was not certified or self-declared under MDD/AIMDD before 26 May 2021, or
  • Underwent significant changes to its design or intended purpose after 26 May 2021,

must comply fully with MDR from the outset — no transitional provisions apply.

IVDR transitional provisions​

Dates of application​

EventDate
IVDR published in Official Journal5 May 2017
Original date of application26 May 2022
IVDR fully applicable from26 May 2022

Class-based deadlines​

IVDR introduced a phased transition based on device risk class:

IVD ClassIVDR Application / DeadlineNotes
Class D26 May 2025Highest risk — shortest transition
Class C26 May 2026Including companion diagnostics
Class B and Class A sterile26 May 2027
Class A non-sterileNo NB involvement — self-certificationMust comply with IVDR from 26 May 2022

These deadlines apply to devices currently certified (or previously self-declared) under IVDD 98/79/EC that require notified body certification under IVDR.

Additional conditions (Regulation (EU) 2022/112) for the phased deadlines:

  • The device was lawfully placed on the market under IVDD before 26 May 2022
  • No significant changes in design or intended purpose have been made since
  • The manufacturer has registered in EUDAMED
  • The manufacturer has submitted a formal application to a notified body by 26 May 2024 (for Class C and D devices)

New IVDs without IVDD certification​

Any IVD that:

  • Was not covered by a valid IVDD self-declaration or CE mark before 26 May 2022, or
  • Has undergone significant design or intended purpose changes,

must comply fully with IVDR from 26 May 2022.

Summary timeline​

2017 ─── MDR and IVDR published (May 2017)
         │
2021 ─── MDR applies (26 May 2021)
         │   MDD/AIMDD transitional period begins
         │
2022 ─── IVDR applies (26 May 2022)
         │   IVDD transitional period begins
         │
2024 ─── NB application deadline for MDR legacy devices (26 May 2024)
         │   NB application deadline for IVDR Class C & D (26 May 2024)
         │
2025 ─── IVDR Class D deadline (26 May 2025)
         │
2026 ─── IVDR Class C deadline (26 May 2026)
         │
2027 ─── MDR Class III / IIb implantables deadline (31 Dec 2027)
         │   IVDR Class B and Class A sterile deadline (26 May 2027)
         │
2028 ─── MDR Class IIb non-impl / IIa / Class Im/Is deadline (31 Dec 2028)
         │   IVDR sell-off for Class D (if placed before deadline)
         │
2029 ─── MDR sell-off provisions expire (31 Dec 2029 for lower classes)

The notified body capacity problem​

The transitional extensions were driven primarily by a critical shortage of notified body capacity. Following MDR/IVDR designation, the number of designated NBs for medical devices was significantly lower than under the Directive era, and the workload per NB increased dramatically.

Key figures (approximate, based on MDCG and NB Forum data):

  • Under MDD: ~60 notified bodies designated
  • Under MDR: ~40 notified bodies designated (as of 2024)
  • Estimated devices requiring MDR recertification: 30,000–50,000
  • Estimated IVDR devices requiring NB certification for first time: 24,000+ (most IVDD devices were self-declared)

The practical consequence is that manufacturers who delay engaging a notified body risk missing their transitional deadline regardless of technical readiness.

What "significant change" means​

A significant change to a device removes it from transitional protection. MDCG 2020-3 defines significant change as:

A change that could affect the safety or performance of the device or alter its intended purpose, such that it would require a new conformity assessment or a substantial modification to existing conformity assessment documentation.

Examples of significant changes:

  • New intended use or patient population
  • New clinical claims
  • Material changes in design, components, or manufacturing
  • Software updates affecting safety-related functions
  • Changes in sterilisation method

Examples that are not typically significant:

  • Administrative updates (manufacturer address, name)
  • Cosmetic labelling updates
  • Manufacturing efficiency improvements with no effect on device output

When in doubt, manufacturers should document their change impact assessment and consult their notified body.

Practical checklist for manufacturers​

  • Identify all devices under MDD/IVDD certification and their current certificate status
  • Determine applicable MDR/IVDR device class for each device
  • Assess whether any significant changes have been made since original certification
  • Submit MDR NB application by 26 May 2024 (if not already done) to preserve transitional eligibility
  • Submit IVDR Class C/D NB application by 26 May 2024
  • Register in EUDAMED and assign SRN
  • Begin EUDAMED device registration and UDI assignment
  • Plan technical documentation gap analysis against MDR/IVDR requirements
  • Review clinical evaluation / performance evaluation for MDR/IVDR compliance

Official references​

ReferenceDescription
Regulation (EU) 2017/745 Art. 120Original MDR transitional provisions
Regulation (EU) 2020/561First MDR extension (COVID-19)
Regulation (EU) 2023/607MDR transitional extension (current)
Regulation (EU) 2017/746 Art. 110Original IVDR transitional provisions
Regulation (EU) 2022/112IVDR phased transitional extension
MDCG 2020-3Guidance on significant changes under MDR transitional provisions
MDCG 2022-4Questions & Answers on IVDR transitional provisions