EU MDR & IVDR Transition Timelines
Regulations (EU) 2023/607 and 2024/1860 extended the transition periods of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) to relieve notified-body capacity pressure and protect device availability. MDR legacy certificates now run to 26 May 2027 for higher-risk devices or 26 May 2028 for medium- and lower-risk devices, conditional on an MDR conformity application by 26 May 2024; IVDR deadlines run to 31 December 2027, 2028, or 2029 by risk class. The extensions also removed the earlier "sell-off" deadline.
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[ POSITION IN THE FRAMEWORK ]
7 DIMENSIONS · 22 LINKSRegulations (EU) 2023/607 and 2024/1860 extended MDR and IVDR transition deadlines by device class to relieve notified-body capacity — scheduling relief, not a reprieve from conformity, and conditional on a timely application.
06 · QUALITY MATURITY — EU MDR & IVDR TRANSITION TIMELINES, REACTIVE TO ADAPTIVE
The extension is treated as a pause; MDR/IVDR conformity work is deferred rather than progressed.
A transition plan exists, but the conditions to benefit and the notified-body milestones are tracked loosely.
Each legacy device is confirmed to meet the conditions, with the application-and-agreement milestones held.
Technical documentation and ISO 13485 work is run to the extended dates, with capacity and gaps forecast per device.
The portfolio's conformity is managed proactively so devices clear MDR/IVDR ahead of their deadlines, not against them.
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07 · REGULATORY & EVIDENCE
GOVERNING STANDARDS · 2
Derived from the 2 standards SPEQ maps to this subject, across 2 regulatory bodies: ISO, EC.
RECORDS & OBJECTIVE EVIDENCE
- Evidence each legacy device still complies with its original directive certificate
- A lodged MDR/IVDR conformity application and signed notified-body agreement
- A compliant ISO 13485 quality management system
- Confirmation of no significant change in design or intended purpose for legacy devices
- MDR/IVDR technical documentation progressed against the extended deadlines
COMMON INSPECTION FINDINGS
- Conformity work deferred on the assumption the extension is a reprieve
- Extended dates relied on without meeting the application-and-agreement conditions
- A legacy device significantly changed yet still relying on the transition
- Quality management system not conformant with ISO 13485
- A device kept on the market past its class-specific transition deadline
Why the deadlines were extended
The MDR and IVDR replaced the older directives with far more demanding conformity-assessment requirements, and notified-body capacity could not certify the whole installed base of devices in time. Without relief, safe, established devices risked dropping off the EU market purely for want of a certificate. Regulation (EU) 2023/607 (MDR) and Regulation (EU) 2024/1860 (IVDR) extended the transition windows to close that gap, on conditions designed to ensure only genuinely compliant-in-progress devices benefit.
MDR deadlines by device class
Under Regulation (EU) 2023/607, legacy MDR transition runs to 26 May 2027 for Class III devices and implantable Class IIb devices, and to 26 May 2028 for other Class IIb, Class IIa, and Class I devices placed on the market under a valid directive certificate. Class III custom-made implantable devices had a transition to 26 May 2026.
The extension is conditional. To benefit, the manufacturer must (among other conditions) have a compliant quality management system, and have lodged a formal MDR conformity-assessment application with a notified body and signed a written agreement — the application milestone being 26 May 2024. Miss the conditions and the extended dates do not apply.
IVDR deadlines by device class
Under Regulation (EU) 2024/1860, IVDR transition periods end on 31 December 2027 for higher-risk (Class D) devices, 31 December 2028 for Class C, and 31 December 2029 for Class B and Class A sterile devices — subject to conditions comparable to the MDR extension. The staggering reflects risk class: the highest-risk diagnostics transition first.
Conditions, and the removed sell-off period
Both extensions removed the "sell-off" deadline that had previously required devices already placed on the market to be withdrawn by a fixed date — so compliant legacy stock in the supply chain is no longer force-expired. But the extended transition is not a blanket pause: it applies only to devices that continue to comply with the directive under which they were certified, have not undergone significant changes in design or intended purpose, and whose manufacturers meet the application-and-agreement conditions.
What manufacturers should do
Treat the extension as scheduling relief, not a reprieve from MDR/IVDR conformity. Confirm each legacy device meets the conditions to benefit, hold to the notified-body application and agreement milestones, and run the MDR/IVDR technical-documentation and QMS (ISO 13485) work to the extended dates rather than against them. SPEQ synthesis: the manufacturers who used the extension to finish conformity — not to defer it — are the ones who keep their portfolios on the EU market.
FREQUENTLY ASKED
What are the new EU MDR transition deadlines?
Under Regulation (EU) 2023/607, MDR legacy transition runs to 26 May 2027 for Class III and implantable Class IIb devices, and to 26 May 2028 for other Class IIb, Class IIa, and Class I devices — provided the manufacturer met the conditions, including lodging an MDR conformity application with a notified body by 26 May 2024. Class III custom-made implantable devices transitioned by 26 May 2026.
What are the IVDR transition deadlines?
Regulation (EU) 2024/1860 sets IVDR transition endings of 31 December 2027 for Class D, 31 December 2028 for Class C, and 31 December 2029 for Class B and Class A sterile devices, subject to conditions — staggered so the highest-risk diagnostics transition first.
Is the extension a reprieve from MDR/IVDR compliance?
No. It is scheduling relief driven by notified-body capacity, not a relaxation of the requirements. It applies only to devices that still comply with their original directive certificate, have not been significantly changed, and whose manufacturers met the application-and-agreement conditions. The MDR/IVDR technical documentation and ISO 13485 quality-system work still has to be completed — just to the extended dates.
What happened to the MDR/IVDR "sell-off" deadline?
Both extensions removed the sell-off period that had required devices already on the market to be withdrawn by a fixed date, so compliant legacy stock already in the supply chain is no longer force-expired. The core transition conditions still apply to placing devices on the market.