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Deadline tracker
The dates everyone plans around, in one place.
Regulatory deadlines are scattered across guidance documents, authority websites and consultancy newsletters. This page collects the ones our clients actually plan against.
What this covers
Four categories.
EU MDR and IVDR transition
Class-dependent transition provisions, certificate validity and the conditions attached to extended timelines.
FDA milestones
Submission review clocks, response deadlines and post-market reporting obligations.
Recurring safety obligations
DSUR, PSUR and PBRER cycles, and the expedited reporting clocks that run from awareness.
Quality and audit cycles
Periodic review, internal audit programmes and supplier requalification intervals.
How to use it
Deadlines move, and guidance is amended more often than most teams track. Treat this page as a planning aid and verify against the current authority publication before you commit to a date in a board pack.
If a date on this page is out of step with what you are seeing, tell us. We would rather be corrected than confidently wrong.
Key dates at a glance
Last reviewed: 10 October 2026. Always confirm against the source before you rely on a date.
| Area | Obligation | Date or clock | Source |
|---|---|---|---|
| EU MDR | Legacy class III and class IIb implantable devices (eligible, conditions met) | 31 December 2027 | Regulation (EU) 2023/607 |
| EU MDR | Other legacy devices, including class IIb, class IIa and upclassified class I (eligible, conditions met) | 31 December 2028 | Regulation (EU) 2023/607 |
| EU IVDR | Legacy class D devices and devices with an IVDD notified body certificate | 31 December 2027 | Regulation (EU) 2024/1860 |
| EU IVDR | Legacy class C devices | 31 December 2028 | Regulation (EU) 2024/1860 |
| EU IVDR | Legacy class B and sterile class A devices | 31 December 2029 | Regulation (EU) 2024/1860 |
| EUDAMED | First four modules mandatory (actor registration, UDI and device registration, notified bodies and certificates, market surveillance) | From 28 May 2026 | European Commission notice, November 2025 |
| FDA devices | Quality Management System Regulation (21 CFR 820 incorporating ISO 13485:2016) in effect | From 2 February 2026 | FDA final rule |
| EU vigilance | Serious incident report by the manufacturer | Within 15 days of awareness; 10 days for death or unanticipated serious deterioration; 2 days for a serious public health threat | MDR Article 87; IVDR Article 82 |
| FDA vigilance | Medical device report | Within 30 calendar days; 5 work days where remedial action is needed to prevent unreasonable risk | 21 CFR Part 803 |
| Clinical trials (US) | IND safety report | Within 15 calendar days; 7 days for unexpected fatal or life-threatening suspected adverse reactions | 21 CFR 312.32 |
| Clinical trials | Development Safety Update Report | Annually, within 60 days of the development international birth date anniversary | ICH E2F |
Conditions matter as much as dates
The EU transition extensions are not automatic. They apply only where the device still complies with the old directive, has no significant changes in design or intended purpose, and the manufacturer put a compliant quality management system in place and applied to a notified body within the deadlines set in the amending regulations. A device that misses a condition loses the extended date.
Changes in progress
In December 2025 the European Commission proposed targeted amendments to simplify the MDR and IVDR. The proposal is going through the EU legislative process, and the dates above remain in force until any amendment is adopted and published. We will update this table when that happens.
Talk to someone who has done this.
Hiring for it, or looking for the work. Either conversation is welcome.