EUDAMED Deadline 28 November 2026 for Legacy Devices

Deadline 28 November 2026: 𝗜𝘀 𝘆𝗼𝘂𝗿 𝗹𝗲𝗴𝗮𝗰𝘆 𝗱𝗲𝘃𝗶𝗰𝗲 𝗱𝗮𝘁𝗮 𝗮𝗰𝘁𝘂𝗮𝗹𝗹𝘆 𝗿𝗲𝗮𝗱𝘆?

Before registration, medical device manufacturers should complete three checks:

👉 𝗠𝗮𝗿𝗸𝗲𝘁 𝘀𝘁𝗮𝘁𝘂𝘀

Will additional units still be placed on the EU market after 28 May 2026?

👉 𝗗𝗲𝘃𝗶𝗰𝗲 𝗶𝗱𝗲𝗻𝘁𝗶𝘁𝘆

Is the legacy device already represented by the same MDR or IVDR device record?

👉 𝗗𝗮𝘁𝗮 𝗰𝗼𝗻𝘀𝗶𝘀𝘁𝗲𝗻𝗰𝘆

Are manufacturer, authorised representative, certificate, EMDN and device identifiers aligned?

Most delays are not caused by entering data into EUDAMED.

They result from unclear product portfolios and inconsistent source information - and a lack of time for preparation.

Start as early as possible with a structured medical device mapping before beginning the registration process.