MDCG 2020-16 Rev.3: Updated IVD Classification Guidance Document
10 July 2024
EU Commission Publishes New IVDR Transition Extension Q&A and Updates to MDR Transition Q&A
15 July 2024Following the formal publication of the gradual EUDAMED rollout, the EU Commission has released an updated draft timeline for EUDAMED implementation. It is available here.
Timeline Overview
The following estimated deadlines are established for gradual EUDAMED rollout:
- Q1-Q3 2025 – Formal publication in the Official Journal of the EU (OJEU) for the 1) Actor, 2) UDI/Device, 3) Notified Bodies/Certificates, and 4) Market Surveillance modules
- Per the recent amendments to the MDR/IVDR, these modules will become mandatory for use 6 months after publication in the OJEU
- Q1 2026 – Mandatory use of 1) Actor, 2) UDI/Device, 3) Notified Bodies/Certificates and 4) Market Surveillance modules
- The exact mandatory date will depend on when notices are published in the OJEU
- Q4 2026 – Transition period for device registration module ends
- Per the recent amendments to the MDR/IVDR, devices already on the market will have 12 months to register in EUDAMED
- Q1-Q2 2026 – Vigilance module notice published in the OJEU
- Q3 2026 – Mandatory use of Vigilance module
- The exact date depends on when the notice is published in the OJEU
- In development through 2026/2027 – Clinical Investigations/Performance Studies module
What’s Next
The timelines are a moving target. As stated in the document, it is a draft file. However, in general, manufacturers should expect that device registration will be required by 2026.
The steps for mandatory use are:
- Each module must first successfully pass an independent audit, verifying it is fully functional.
- User guides will be provided on machine-to-machine (M2M) use.
- Notice of mandatory use will be published in the Official Journal of the EU (OJEU).
- Six months after publication in the OJEU, use of the module will become mandatory.
- From this point, manufacturers will have a twelve (12) month transition period to enter all their device data into the UDI/Devices module. This is applicable to both Regulation and Device devices.
Therefore, if the 1) independent audits are finalized this year, and 2) the M2M guides are issued within the timelines stipulated in the document, then the modules will be on track for publication in the OJEU within the first half of 2025.
EUDAMED Resources
- EUDAMED Overview: EU Medical Device Database
- What is a Single Registration Number (SRN) & How to obtain yours
- Actor Registration Module: How to register your company in EUDAMED
- UDI/Devices Module: How to register your devices in EUDAMED
- EMDN Codes: How to find and select codes for EUDAMED registration
