Introduction
Regulation (EU) 2023/607 gave the medical device industry crucial breathing room by extending transition dates for legacy devices to 31 December 2027 for high-risk devices and 31 December 2028 for medium- and low-risk devices.
However, this extension created a common misconception: that market access is guaranteed until the final cutoff.
The reality is that the extension is strictly conditional. Notified Body reviews can take many months, sometimes longer, so waiting until the deadline approaches may leave manufacturers stranded with expired certificates and blocked EU shipments.
Deadlines by Risk Class
- 31 December 2027 — High-Risk Devices:
Class III devices; Class IIb implantable devices (except well-established technologies such as sutures, staples, dental fillings, braces, crowns, screws, wedges, plates, wires, pins, clips and connectors)
- 31 December 2028 — Medium- and Low-Risk Devices:
Other Class IIb devices; Class IIa devices; Class I devices under the MDD that are sterile or have a measuring function; reusable surgical instruments
Note that the former sell-off deadline no longer applies. Devices lawfully placed on the market during the transition can continue to be made available.
The Conditions for Extension
To keep legacy market access valid, manufacturers must meet four clear criteria:
1. Valid legacy status: The device must hold a valid MDD or AIMDD certificate (or a declaration of conformity, for devices that were self-certified under the directives) issued before 26 May 2021, and it must not have been withdrawn or expired without extension.
2. No significant changes: Any change to the design or intended purpose must be assessed against MDCG 2020-3 Rev. 1. A change that crosses the threshold ends legacy status for that device. Engineering change control is therefore now a regulatory control point.
3. An MDR-aligned quality system: From 26 May 2024, manufacturers had to have a QMS meeting Article 10(9), including post-market surveillance and vigilance processes that work to MDR standards.
4. A Notified Body application and agreement: The manufacturer had to lodge a formal MDR application by 26 May 2024 and sign a written agreement with the Notified Body by 26 September 2024.
If you cannot produce evidence for all four, you do not have a timeline problem. You have a legacy-status problem, and it needs attention first.
Common Pitfalls for Manufacturers
- Informal change creep
A supplier switch, a labelling update or a software patch can each be argued as “minor”. Without a documented significance assessment, you cannot defend that position to an auditor or authority.
- Clinical evidence built on equivalence
Many MDD-era clinical evaluation reports rely heavily on literature and claimed equivalence. Under the MDR, equivalence is tightly constrained. Expect Notified Bodies to ask for device-specific clinical data and a credible, funded PMCF plan.
- Late technical documentation
Notified Body review is iterative: questions, responses, further questions. Capacity is limited, and timelines vary by body and device type. A dossier that is still being rewritten in 2027 may not clear review before the deadline.
- Weak supply chain evidence
Importers and distributors have their own obligations under Articles 13 and 14. Many now ask for your Notified Body agreement and application evidence before accepting the product.
The extension was designed to protect patient access to important devices while manufacturers transition, not to postpone MDR work. Manufacturers who protect their legacy conditions and give Notified Bodies a complete, well-evidenced dossier in good time will keep their EU market access. Those who wait will find that the final date arrives faster than any review process can respond.
References
Regulation (EU) 2023/607
Regulation (EU) 2017/745 (MDR)
MDCG 2020-3 Rev. 1, significant changes under Article 120
