EUDAMED deadline calculator
Select your device’s regime, market status and certificate to see your EUDAMED and ÜTS deadlines together with the legal basis and official sources.
Rules as of 12 October 2026 · rules version 1.1.0
Not legal advice
This tool provides general information based on public official sources and is not a substitute for legal or regulatory advice. Dates reflect the legislation and Commission publications as of the stated “as of” date and may change. Items marked “estimated” are not based on an official date. Base your decisions on the official texts and your regulatory affairs expert’s advice.
Scope: custom-made devices, investigational devices and devices for performance studies, as well as the clinical investigation module (still under analysis), are outside this calculator. Results are per device; run it separately for each of your devices.
Key dates
- 27 November 2025
- Commission Decision (EU) 2025/2371 on the functionality of the first four modules published in the Official Journal [2]
- 28 May 2026
- Actor, UDI/Device, Notified Bodies & Certificates and Market Surveillance modules mandatory [6]
- Before 28 November 2026
- End of the transition period for UDI/Device registration of devices placed on the market before 28 May 2026 whose units are still placed [8]
- Before 28 May 2027
- End of the transition period for notified bodies to enter MDR/IVDR certificates issued before 28 May 2026 [10]
- Q2 2027Estimated
- Mandatory use of the Vigilance module (estimated; no official date) [11]
Sources
Every rule is based on the primary sources below. Documents are in their original language.
- [1]Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed (OJ L, 9.7.2024)EUR-Lex · Retrieved: 12 October 2026
- [2]Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding functionality of certain electronic systems in Eudamed (OJ L, 27.11.2025)EUR-Lex · Retrieved: 12 October 2026
- [3]Regulation (EEC, Euratom) No 1182/71 determining the rules applicable to periods, dates and time limits (OJ L 124, 8.6.1971)EUR-Lex · Retrieved: 12 October 2026
- [4]Regulation (EU) 2017/745 on medical devices (MDR), consolidated textEUR-Lex · Retrieved: 12 October 2026
- [5]Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), consolidated textEUR-Lex · Retrieved: 12 October 2026
- [6]EUDAMED overview: mandatory use of the first four modules since 28 May 2026European Commission, DG SANTE · Retrieved: 12 October 2026
- [7]Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed (MDR/IVDR as amended by Regulation (EU) 2024/1860)European Commission, DG SANTE · Retrieved: 12 October 2026
- [8]EUDAMED transition period: Legacy and Regulation devices placed on the market before the mandatory useEuropean Commission, DG SANTE · Retrieved: 12 October 2026
- [9]EUDAMED 6 months transitional period: Regulation devicesEuropean Commission, DG SANTE · Retrieved: 12 October 2026
- [10]EUDAMED transition period: Certificates registrationEuropean Commission, DG SANTE · Retrieved: 12 October 2026
- [11]EUDAMED modules Timeline, November 2025 (Vigilance timeline may be updated depending on audit results)European Commission, DG SANTE · Retrieved: 12 October 2026
- [12]EUDAMED Actor registration moduleEuropean Commission, DG SANTE · Retrieved: 11 October 2026
- [13]Notice to stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices (March 2022)European Commission, DG SANTE / DG NEAR · Retrieved: 11 October 2026
- [14]Tıbbi Cihaz Yönetmeliği (RG 2/6/2021-31499 mükerrer; değişiklik RG 17/8/2024-32635)Mevzuat Bilgi Sistemi (T.C. Cumhurbaşkanlığı) · Retrieved: 12 October 2026
- [15]İn Vitro Tanı Amaçlı Tıbbi Cihaz Yönetmeliği (RG 2/6/2021-31499 mükerrer; değişiklik RG 17/8/2024-32635)Mevzuat Bilgi Sistemi (T.C. Cumhurbaşkanlığı) · Retrieved: 12 October 2026
- [16]Ürün Takip Sistemi (ÜTS)Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK) · Retrieved: 11 October 2026
- [17]Tıbbi Cihazların Ürün Takip Sistemine Kayıt Süreçlerine İlişkin Kılavuz (V.4.0, 13/05/2026)Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK) · Retrieved: 11 October 2026
- [18]Tıbbi Cihazların Ürün Takip Sistemi Tekil Hareket Bildirimlerine İlişkin Kılavuz (03/02/2022)Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK) · Retrieved: 11 October 2026
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