EU · MDR

MDR transition deadline calculator

Answer three questions to see which extended deadline applies to your device, whether you meet the conditions of Regulation (EU) 2023/607 and how many days you have left.

Preliminary guidance only, not a legal or regulatory determination. Confirm your status with your notified body and the official text of Regulation (EU) 2023/607. Your answers never leave your browser.

1. Which device group does your MDD certificate (or declaration) cover?

Class III Class IIb implantableexcept sutures, staples, dental fillings, braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors Class IIb implantable “WET” itemssutures, staples, dental fillings, braces, tooth crowns, screws, wedges, plates, wires, pins, clips, connectors Class IIb, not implantable Class IIa Class I sterile or with measuring function (Is / Im) Class I self-declared under MDD that needs a notified body under MDRe.g. up-classified, or reusable surgical instruments (Ir); MDD declaration of conformity drawn up before 26 May 2021 Class I under MDD that stays Class I without a notified body

2. What is the status of your MDD certificate?

Still within its original validity Expired after 20 March 2023 Expired before 20 March 2023

3. Which conditions of Regulation 2023/607 do you meet?

The device continues to comply with the MDD (or AIMDD) No significant changes in design or intended purpose The device does not present an unacceptable risk to health or safety An MDR-compliant quality management system (Art. 10(9)) was in place by 26 May 2024 A formal application was lodged with an MDR notified body by 26 May 2024 A written agreement with the notified body was signed by 26 September 2024

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FAQ

What did Regulation (EU) 2023/607 change?

It extended the MDR transition periods for devices with MDD or AIMDD certificates: to 31 December 2027 for Class III and Class IIb implantable devices (with listed exceptions), and to 31 December 2028 for other devices, provided specific conditions are met.

Can we change our device during the transition?

Not significantly. Devices relying on the extension must have no significant changes in design or intended purpose. Assess and document each change.

Which MDR requirements already apply during the transition?

Even for legacy devices, MDR requirements on post-market surveillance, market surveillance, vigilance and registration of economic operators and devices apply.