Regulation 2023/607 in Practice: Who Qualifies for Extended Deadlines

The three conditions that determine your deadline

Regulation 2023/607 extended the MDR transition deadlines for legacy devices, but only if three conditions are met simultaneously. First, the device must have held a valid MDD or AIMDD certificate as of 26 May 2021 — the MDR application date — or must have had a certificate issued after that date under the remaining MDD transitional provisions. Second, the device must not have undergone significant changes in design or intended purpose. Third — and this is the one most teams stumble on — a written agreement with a Notified Body for MDR conformity assessment must have been in place, or an application must have been submitted, by 26 May 2024.

If your device does not meet all three, the extended deadlines do not apply. This does not necessarily mean your device is non-compliant today, but it does mean you need to assess whether you are still operating within a valid transition window or whether you have already exceeded it.

What "written agreement with a Notified Body" actually means

The regulation uses the phrase "written agreement" deliberately. A quote, a preliminary discussion, or a slot on a Notified Body's waiting list does not qualify. What you need is a signed contract — typically a review agreement or audit agreement — confirming that the Notified Body has accepted your device for MDR conformity assessment review. If you submitted a formal application that was accepted by the Notified Body before the 26 May 2024 cutoff, that also qualifies.

One practical issue: some manufacturers signed agreements with Notified Bodies that have since lost their designation for certain device classes or scopes. If your Notified Body's designation no longer covers your device type, the agreement may not be sufficient. You need a current, designated Notified Body working on your active MDR file — not just a historical agreement with a body that can no longer certify your device.

Verifying which deadline regime applies to your device

Start by confirming the certificate status as of 26 May 2021. Pull the certificate itself and check the expiry date, the issuing Notified Body, and whether any amendments or extensions were issued after May 2021. Then check whether the device was placed on the market after 26 May 2021 under MDD — if so, it must have been placed under the MDD transitional provisions (Article 120(3)), which imposed its own conditions.

Next, document your Notified Body agreement. This means having the signed contract or acceptance confirmation in your QMS with the date clearly recorded. If you cannot locate this document or if it was never formalized in writing, you have a gap that needs to be resolved with your Notified Body as quickly as possible.

Finally, check for significant changes. The regulation does not define "significant" exhaustively, but MDCG 2020-3 provides guidance. Changes that affect the risk profile, the intended purpose, or the clinical basis of the device trigger MDR requirements regardless of the transition status. If you have made changes since the original MDD certification, review them against MDCG 2020-3 to determine whether the legacy transition route is still available to you.

The EUDAMED dimension

One requirement that runs in parallel with the transition conditions is EUDAMED registration. Even legacy devices still being placed on the market under transition conditions are subject to EUDAMED Basic UDI-DI registration obligations that were phased in from 2021 onward. Transition status does not exempt you from these obligations. Check whether your device's Basic UDI-DI is registered and whether the actor registration for your organization is complete — these are live obligations, not future ones.

What to do if you are out of scope for the extension

If your device does not qualify for the extended deadlines — because the Notified Body agreement was not in place in time, or because the device has undergone significant changes, or because the certificate conditions are not met — your options narrow quickly. The remaining paths are: accelerated MDR certification (which depends on Notified Body capacity), withdrawal from the EU market for that product, or, in limited cases, exploring whether a different classification or conformity assessment route opens an alternative path. None of these are straightforward, and all of them take time that may already be running short.