MDR Transition Deadlines: What 31 December 2027 and 2028 Mean for Your Legacy CER

Qmedify Regulatory Team · Last updated October 2026

If your device is still certified under the old Medical Devices Directive (MDD), you are working against a clock that was extended once already and will not be extended again. Regulation (EU) 2023/607 pushed the MDR transition deadlines for legacy devices out to 31 December 2027 or 31 December 2028, depending on risk class — but only for manufacturers who met a set of conditions back in 2024. The extension bought time. It did not reduce what has to be done before the deadline, and for most legacy CERs, there is more to do than a document refresh.

What are the actual deadlines?

Regulation (EU) 2023/607 amends Article 120 of the MDR and sets staggered deadlines by device risk class:

Deadline Applies to
26 May 2026 Class III custom-made implantable devices
31 December 2027 Class III devices and class IIb implantable devices (with some exceptions)
31 December 2028 Class IIa and other class IIb devices, class I devices placed on the market sterile or with a measuring function, and class I devices under the old directives that now require Notified Body involvement under MDR

After the applicable deadline, a legacy device can no longer be placed on the market or put into service under its old MDD/AIMDD certificate.

Why does the extension not mean "nothing to do yet"?

The extended deadlines came with conditions that most legacy-device manufacturers already had to meet. To qualify for the longer transition period, manufacturers needed to, no later than 26 May 2024, put a quality management system in place consistent with MDR Article 10(9) and lodge a formal application for MDR conformity assessment with a Notified Body. If that didn't happen, the shorter original MDR transition timeline applies instead.

In other words, the 2027/2028 dates are not a grace period that starts counting down from today. For most manufacturers using the extension, the clock has been running since 2024 — Notified Body capacity is limited, review cycles take months, and a Clinical Evaluation Report written for MDD standards still has to be brought up to MDR Annex XIV before a Notified Body will sign off.

What specifically changes between an MDD-era CER and an MDR-compliant one?

A CER written under the old MEDDEV 2.7/1 Rev. 4 approach was built around a different standard of evidence than MDR Article 61 and Annex XIV require. Common gaps we see in legacy CERs include:

  • Equivalence claims that no longer hold up. MDR Article 61(5) adds conditions — including contractual access to the equivalent device's technical documentation — that MDD-era equivalence arguments rarely addressed.
  • Thin or outdated literature searches. A search protocol that was adequate five years ago is unlikely to meet current expectations for being documented, repeatable, and current.
  • PMCF that exists on paper but wasn't executed, or was executed but never folded back into the CER's benefit-risk conclusion.
  • Claims with no traceable evidence behind them — a sentence in the CER that nobody could point to a source for if a Notified Body reviewer asked.

None of these show up by skimming the document. They show up when the CER is checked section by section against what Annex XIV and MDCG 2020-13 actually expect a Notified Body to find.

What should you do before your deadline?

  1. Confirm which deadline actually applies to your device — risk class, and whether you met the 2024 conditions for the extension.
  2. Get a gap analysis of your current CER against MDR Annex XIV and MDCG 2020-13, not just a read-through. The gaps that matter are usually structural (equivalence, evidence traceability, PMCF integration), not cosmetic.
  3. Prioritize. Not every gap needs the same urgency — a remediation plan should tell you what blocks certification versus what can be improved on the next PMCF cycle.
  4. Build in Notified Body review time. Whatever internal deadline you set, leave real margin before the regulatory one.

Key takeaways

  • Regulation (EU) 2023/607 set the legacy device transition deadlines at 31 December 2027 or 2028, depending on risk class — but only for manufacturers who met the 2024 quality-system and application conditions.
  • The extension is not a new grace period starting now; for most manufacturers, the clock has been running since 2024.
  • A CER written to the old MEDDEV approach typically needs a structural gap assessment against MDR Annex XIV and MDCG 2020-13, not a light edit.
  • The most common legacy CER gaps are equivalence claims, outdated literature searches, unexecuted or unintegrated PMCF, and unreferenced claims.

Not sure where your CER stands against the MDR requirements? Our Legacy CER Gap Analysis gives you a gap report, a claims-to-evidence map, and a prioritized remediation plan in 10 working days.

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