MDR Transition Deadlines by Device Class: A Practical Timeline

Why there is no single transition deadline

After Regulation 2023/607, the transition deadline depends on your device class. This is one of those things that sounds simple but creates real confusion in practice — particularly in companies managing a mixed portfolio where different products are sitting in different deadline buckets. The table below summarises the key dates, but the explanations underneath are where the practical detail lives.

Class IIb and Class III (implantables and highest risk)

For Class IIb implantable devices (excluding sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors) and for Class III devices, the extended transition deadline is 31 December 2027 for placing on the market. Devices already placed on the market before that date can continue to be made available and put into service until 31 December 2028.

This is the longest extension, and it reflects the complexity of transitioning the highest-risk devices. But "longest" is relative — if you are only starting MDR certification work now, December 2027 is not far away for a Class III device. Notified Body timelines for Class III typically run 18–24 months from application to certificate, and that assumes a well-prepared technical file and no major questions. The teams that will make this deadline comfortably are the ones who started in 2022 or 2023.

Class IIa and lower-risk Class IIb (non-implantable)

For Class IIa devices and for Class IIb devices that are not implantable (and not in the higher-risk sub-category above), the transition deadline for placing on the market is 31 December 2026. The sell-off tail runs to 31 December 2027.

December 2026 is the date that should be driving urgency for the largest volume of legacy devices right now. Most Class IIa devices are not simple to certify under MDR — the clinical evaluation requirements are substantially higher than MDD, and many Class IIa technical files need significant work. If you are at the pre-submission stage with your Notified Body today, you have very little margin.

Class I (self-certified, no Notified Body required)

Class I devices under MDD were self-certified, and many had no Notified Body involvement at all. Under MDR, Class I devices that remain Class I are also self-certified — so there is no Notified Body bottleneck. The transition deadline for Class I is 31 December 2028 for placing on the market, with a sell-off tail to 31 December 2028 as well (no additional sell-off extension because the placing deadline is already the latest).

The catch here is reclassification. MDR's classification rules are different from MDD's, and some devices that were Class I under MDD are Class IIa or higher under MDR. If your device has been reclassified upward, the self-certification route is gone, and you are subject to the Class IIa or IIb deadlines instead — not the Class I ones. Checking reclassification status before assuming the 2028 deadline applies is essential.

Class Is (sterile) and Class Im (measuring function) — a separate path

Class I devices with a sterile or measuring function under MDD required Notified Body involvement for those specific aspects. Under MDR, these devices generally remain in a similar position — self-certified for most aspects but with Notified Body review for the sterile or measuring elements. The transition provisions treat these in line with the broader Class I regime for the purpose of deadlines, but the Notified Body agreement requirement still applies to the aspects requiring NB review.

What "placing on the market" means in this context

The deadlines above refer to when a device can be placed on the market — the point at which the device is made available to a distributor or end user for the first time in the EU. After the placing deadline, you cannot release new stock. But devices already placed on the market before the deadline can continue to flow through the supply chain and be put into service by healthcare professionals during the sell-off window.

This distinction matters for inventory planning. If you have stock manufactured and released before your placing deadline, that stock retains its eligibility for the sell-off period. If your stock is manufactured and released after the deadline, it cannot be placed on the market regardless of when it was manufactured.

The interaction with Notified Body timelines

The deadlines above only work if your Notified Body can complete the review in time. As of mid-2026, Notified Body capacity remains constrained — some bodies have application-to-audit timelines of 12 months or more for Class IIa, and longer for Class IIb and III. If you do not already have an active review file at your Notified Body, start a frank conversation with them about whether your target deadline is achievable before building a project plan around it.