EU MDR and IVDR Transition Timeline: Legacy Device Deadlines (2026-2029)

The EU Medical Device Regulation Transition: Where We Stand in 2026

The European Union's transition from the Medical Devices Directive (MDD 93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD 90/385/EEC) to the Medical Device Regulation (MDR 2017/745) — and from the In Vitro Diagnostic Directive (IVDD 98/79/EC) to the In Vitro Diagnostic Regulation (IVDR 2017/746) — is the most significant regulatory overhaul in the history of European medical device regulation.

The original MDR deadlines proved unworkable due to Notified Body capacity constraints, the complexity of MDR requirements, and the risk of device shortages. Regulation (EU) 2023/607 extended the transition periods, and Regulation (EU) 2024/1860 further extended IVDR deadlines. As of April 2026, the first extended deadline has arrived.

This guide provides the complete, current timeline for both medical devices and IVDs, the conditions you must meet to qualify for extended transition periods, and practical steps to maintain EU market access.

Medical Device (MDR) Transition Deadlines

Complete MDR Transition Timeline

Device Category	Transition Deadline	Key Conditions
Simple Class I devices (non-sterile, no measuring function, not reusable surgical instruments)	Already expired (May 26, 2021)	Must comply with MDR now
Class III custom-made implantable devices	May 26, 2026	QMS certificate from NB required by this date
Class III devices and implantable Class IIb (except certain WET devices*)	December 31, 2027	Must have MDR CE marking
Class IIb (all other), Class IIa, Class Is/Im/Ir, Class I self-certified (requiring NB under MDR)	December 31, 2028	Must have MDR CE marking
Certain WET devices (sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, connectors)	December 31, 2028	Classified as Class IIb implantable but get the later deadline

*"WET" devices refers to specific Class IIb implantable devices that receive the later 2028 deadline.

Conditions for MDR Transition Eligibility (Article 120(3c))

To benefit from the extended transition period, all of the following conditions must be met:

1. The device continues to comply with the MDD or AIMDD (whichever applies)
2. No unacceptable risk to health and safety
3. No significant changes to the device design and intended purpose
4. QMS in accordance with MDR Article 10(9) must have been in place no later than May 26, 2024
5. Formal application with a Notified Body for MDR conformity assessment was lodged by May 26, 2024
6. Written agreement with a Notified Body was signed by September 26, 2024

What Does Not Qualify for Transition

"New" devices — those that did not have a valid MDD/AIMDD certificate or declaration of conformity before the applicable date of application — are not eligible for transition provisions. Any medical device newly CE marked after May 26, 2021 must be CE marked to the MDR.

IVD (IVDR) Transition Deadlines

Complete IVD Transition Timeline

The IVDR transition follows a similar staggered approach, with deadlines reflecting the later date of application:

IVD Category	Transition Deadline	NB Application Deadline	NB Agreement Deadline
Class A (non-sterile)	Already expired (May 26, 2022)	N/A	N/A
IVDD NB-certified devices (all classes)	December 31, 2027	May 26, 2025	September 26, 2025
Class D (self-declared under IVDD)	December 31, 2027	May 26, 2025	September 26, 2025
Class C (self-declared under IVDD)	December 31, 2028	May 26, 2026	September 26, 2026
Class B (self-declared under IVDD)	December 31, 2029	May 26, 2027	September 26, 2027
Class A sterile (self-declared under IVDD)	December 31, 2029	May 26, 2027	September 26, 2027

Conditions for IVDR Transition Eligibility (Article 110(3c))

All of the following must be met:

1. The device continues to comply with IVDD
2. No unacceptable risk to health and safety
3. No significant changes to design and intended purpose
4. IVDR-compliant QMS in place by May 26, 2025
5. Formal application with a Notified Body within the class-specific deadline
6. Written agreement with a Notified Body signed within 4 months after the application deadline
7. For IVDD-certified devices: the certificate must have been valid on July 9, 2024

Why Time Is Shorter Than You Think

For Class D IVDs with a December 31, 2027 deadline, the math is sobering:

• Final deadline: December 31, 2027
• Notified Body review time: 18-24 months minimum (just the assessment)
• Technical documentation preparation: 6-12 months before submission
• If clinical performance studies are needed: add 12-24 months
• Total lead time: 36-48+ months

For Class C IVDs (deadline December 31, 2028), approximately 80% of legacy IVDs are Class B and C combined. When this wave hits the limited number of IVDR-designated Notified Bodies, capacity will disappear. Manufacturers who start now have options — those who wait will be at the back of a long queue.

The Sell-Off Provision: Removed

The EU has removed the sell-off date from both MDR Article 120(4) and IVDR Article 110(4). This means:

• Devices that were lawfully placed on the EU market before May 26, 2021 (under MDD/AIMDD) or before May 26, 2022 (under IVDD) — or during the applicable transition period — may continue to be made available on the market or put into service without any time limitation
• The only limitation is the device's own shelf-life or expiry date
• This provides significant relief for distributors and healthcare providers holding inventory

EUDAMED Mandatory Registration Timeline

EUDAMED is now entering its mandatory phase, adding another layer of compliance deadlines:

Date	Requirement
November 27, 2025	EUDAMED Modules 1, 2, 3, and 6 declared functional
May 28, 2026	Mandatory registration of new MDR/IVDR devices begins. NBs begin uploading new certificates. All economic operators must have Actor Registration and SRN
November 27, 2026	Mandatory registration of legacy (MDD/AIMDD/IVDD) devices
May 28, 2027	NBs complete uploading certificates issued before May 2026
TBD	Vigilance and Clinical Investigation modules declared functional

What This Means for Legacy Device Manufacturers

• You must register all legacy devices in EUDAMED by November 27, 2026
• You must have your Actor Registration (SRN) before you can register devices
• Non-EU manufacturers need their EU Authorized Representative to verify registration
• Device master data (UDI-DI, trade names, product groupings) must be consistent across all documentation

Practical Compliance Checklist by Deadline

May 2026 Deadlines (Imminent)

• Class III custom-made implantable devices: MDR QMS certificate from Notified Body must be in place
• EUDAMED Actor Registration completed for all economic operators (manufacturers, EU ARs, importers)
• SRN obtained for all economic operators
• Plan for new device registration in EUDAMED before first placement on market after May 28, 2026

December 2027 Deadlines

• Class III and implantable Class IIb devices: MDR CE marking obtained
• IVDD-certified IVDs and Class D self-declared IVDs: IVDR CE marking obtained
• Legacy devices registered in EUDAMED (by November 27, 2026)
• MDR-compliant Clinical Evaluation Reports completed
• Post-market surveillance and PMCF systems fully operational

December 2028 Deadlines

• Class IIa, Class IIb (non-implantable), and Class Is/Im/Ir devices: MDR CE marking obtained
• Class C IVDs: IVDR CE marking obtained
• All legacy device EUDAMED registrations verified and current

December 2029 Deadlines

• Class B IVDs and Class A sterile IVDs: IVDR CE marking obtained
• NB applications lodged by May 26, 2027
• NB agreements signed by September 26, 2027

Common Pitfalls and How to Avoid Them

1. Waiting Too Long for Notified Body Engagement

Notified Body capacity remains a critical bottleneck. With fewer than 40 NBs designated under MDR and approximately 19 under IVDR, review queues are long. Start the conformity assessment process as early as possible — the application and agreement deadlines are prerequisites, not the final compliance dates.

2. Treating Legacy CERs as MDR-Compliant

A clinical evaluation report written under MDD standards is unlikely to meet MDR expectations without significant updates. Notified bodies now expect:

• Up-to-date clinical evidence reflecting current state of the art
• Strong alignment between CER, PMS, and PMCF data
• Transparent benefit-risk conclusions
• Continuous lifecycle process, not a one-time document

3. Overlooking QMS Requirements

The MDR QMS must have been in place by May 26, 2024 for medical devices and May 26, 2025 for IVDs. If your QMS was not updated by these dates, your devices may not qualify for the extended transition period.

4. Significant Changes to Legacy Devices

Making "significant changes" to a legacy device's design or intended purpose disqualifies it from the transition period. Use MDCG 2020-3 Rev.1 guidance to determine what constitutes a significant change and plan your modifications accordingly.

5. Assuming Certificate Validity Is Automatic

Even with the extension, certificates can be withdrawn if conditions are not met. Manufacturers must maintain ongoing compliance with the underlying Directives throughout the transition period. Additionally, if you change Notified Bodies, specific arrangements must be defined in a tripartite agreement between the manufacturer, incoming NB, and outgoing NB.

Key Takeaways

1. May 26, 2026 is the first MDR deadline — Class III custom-made implantable devices must have an MDR QMS certificate, and EUDAMED registration becomes mandatory for new devices
2. Class III and implantable Class IIb devices must have MDR CE marking by December 31, 2027
3. All remaining medical devices must have MDR CE marking by December 31, 2028
4. IVD deadlines extend to December 31, 2029 for Class B and Class A sterile devices
5. EUDAMED registration is mandatory — legacy devices must be registered by November 27, 2026
6. Start Notified Body engagement early — 18-24 months for NB review alone, plus 6-12 months for documentation preparation
7. The sell-off provision has been removed — devices lawfully placed on the market can continue to be sold without time limitation