Legacy Device Transition
Legacy Device Transition Readiness Assessment
Legacy Device Transition Under EU MDR: What Changed and Where Things Stand
An overview of the Article 120 transition provisions, the original MDR deadlines, and how Regulation 2023/607 reshaped the timeline for legacy devices still on the market.
Legacy Device Equivalence Reassessment: Why the MDR Bar Is Higher Than MDD
A practical guide to reassessing equivalence claims for legacy devices under MDR — what has changed from MDD, why third-party equivalence is effectively closed for most manufacturers, and how to decide whether to pursue equivalence, use your own data, or generate new clinical evidence.
Managing MDR Transition Across Multiple Device Families: A Practical Programme Guide
How to structure and run an MDR transition programme when you have multiple legacy device families at different stages — portfolio prioritisation, workstream sequencing, Notified Body coordination, and how to avoid the bottlenecks that cause transitions to slip.
Regulation 2023/607 in Practice: Who Qualifies for Extended Deadlines
A practical guide to the conditions under Regulation 2023/607 — which devices qualify for extended MDR transition deadlines, what the Notified Body agreement requirement means, and how to verify which regime applies to your device.
MDR Transition Deadlines by Device Class: A Practical Timeline
Class-by-class breakdown of MDR transition deadlines after Regulation 2023/607 — what applies to Class III, IIb, IIa, and Class I devices, and what each deadline actually means in terms of placing on the market.
MDD-to-MDR Clinical Evaluation Gap Analysis: What Legacy CERs Are Missing
A practical gap analysis of what MDD-era Clinical Evaluation Reports typically lack under MDR requirements — the common shortfalls, why they matter, and how to close them efficiently.
Legacy Device PMS Uplift: What MDR Requires vs What Most MDD Systems Had
A practical guide to upgrading post-market surveillance systems for legacy devices transitioning from MDD to MDR — the specific gaps most MDD-era PMS plans have and how to close them before your Notified Body review.
Legacy Device Transition
If your devices were CE marked under MDD or AIMDD and you haven't yet completed the switch to MDR, you're not alone — but the window is narrowing. Article 120 of MDR set out the original transitional provisions, and Regulation (EU) 2023/607 extended the deadlines for devices already certified under MDD or AIMDD. Understanding exactly where your device stands under those provisions — and what you still need to do — is the first practical step.
One thing that trips up a lot of teams is assuming the transition is just about getting a new certificate. It's more than that. MDR requires manufacturers of legacy devices to have a written agreement with a Notified Body to transition, and that agreement must have been in place by 26 May 2024 for the extended deadlines to apply. If that agreement didn't happen, the earlier Article 120 deadlines apply — and for some device classes, those have already passed. Knowing which deadline regime your device is under is not optional information.
The transition deadline itself varies by device class: the longest runway under 2023/607 runs to December 2028 for implantable Class III devices and to December 2027 for Class IIb and higher-risk Class IIa devices. But the deadline for placing on the market is different from the deadline for sell-off. Devices that were legally placed on the market before the deadline can continue to be made available and put into service within defined limits — up to 2 additional years post-deadline in most cases. Conflating "placing on market" and "making available" is a common source of confusion that creates unnecessary alarm or — worse — missed obligations.
What the transition actually requires in practice is a full MDR technical file, updated clinical evaluation, a compliant PMS plan, and UDI registration. None of those are trivial for a device that was documented to MDD standards. Clinical evaluation is usually where the most significant gap is found: MDD-era CERs often don't meet the Article 61 and Annex XIV standard. If your legacy device relied on MDD-era equivalence claims, those will need reassessment — the MDR equivalence bar is meaningfully higher. Resources in this category work through what a realistic transition plan looks like for different device types and risk classes.
The EUDAMED and UDI obligations don't wait for your transition to complete. Registration requirements apply as MDR's modules roll out, and the UDI assignment timelines are not aligned with the transition certificate deadlines. This is one of the areas where teams often discover they're behind on a parallel track they hadn't been tracking closely. If you're managing a transition portfolio across multiple device families, this category is designed to help you sequence the work and avoid the most common pitfalls.
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