Check each certificate
Confirm that the application and the written agreement cover every device on each legacy certificate.
Regulation (EU) 2023/607
Regulation (EU) 2023/607 extended the MDR transition period for devices covered by certificates or declarations issued under the old Directives - but only for manufacturers that meet a set of conditions.
| Legacy device | May be placed on the market until |
|---|---|
| Class III devices and Class IIb implantable devices (except sutures, staples, dental fillings, braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) | 31 December 2027 |
| Other Class IIb devices, Class IIa devices, and Class I devices placed on the market in sterile condition or with a measuring function | 31 December 2028 |
| Devices that were Class I under the MDD (self-declared) but need a Notified Body under the MDR (up-classified) | 31 December 2028 |
Regulation (EU) 2023/607 also removed the "sell-off" date, so legacy devices already placed on the market can continue to be made available.
Manufacturers that missed the May and September 2024 milestones cannot rely on the extension; their legacy certificates did not benefit from the extended validity.
Confirm that the application and the written agreement cover every device on each legacy certificate.
Assess every design or intended purpose change against MDCG 2020-3 before implementing it.
Technical documentation, clinical evaluation and PMS must be complete well before the Notified Body audit.
Notified Body capacity is limited - late files risk missing 2027 or 2028.
Until 31 December 2027 for Class III and most Class IIb implantable devices, and until 31 December 2028 for other Class IIb, Class IIa and Class Is/Im devices, provided the conditions of Regulation (EU) 2023/607 are met.
A quality management system under Article 10(9) MDR by 26 May 2024, a formal application to a Notified Body by 26 May 2024 and a signed written agreement with the Notified Body by 26 September 2024, plus continued compliance with the Directive and no significant changes.
Only if the change is not significant in design or intended purpose. Significant changes end the device's legacy status; MDCG 2020-3 explains how to assess them.
What the MDR file must contain.
Annex IX, X and XI by class.
Notified Body availability.
Note: This guide provides general information about Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), not legal advice. Check the consolidated text on EUR-Lex and the relevant MDCG guidance for your device. Last reviewed 30 September 2026.