🇪🇺 EMDN Update 2025: What Medical Device Manufacturers Need to Know
Medical devices regulation
Published April 2025 – by CSDmed, consulting firm for medical device development and compliance
Context and relevance
The European Medical Device Nomenclature (EMDN) is a central component of compliance under Regulation (EU) 2017/745 (MDR). Each medical device must be assigned an EMDN code to be registered in EUDAMED, which directly impacts UDI-DI registration, post-market surveillance, notified body audits, and regulatory documentation.
In early 2025, the MDCG released five major documents concerning EMDN updates. This article provides a clear and practical summary of these updates, tailored to medical device manufacturers.
Key documents published
- MDCG 2025-1: Ad hoc request form for EMDN updates
- MDCG 2025-2: Results of the 2024 public consultation on EMDN updates
- MDCG 2025-3: Excel file with updated EMDN codes
- MDCG 2024-2 Rev.1: Updated procedures for the annual EMDN revision
- MDCG 2021-12 Rev.1: Updated EMDN FAQ
What has changed – and why it matters
1. A structured ad hoc request process
MDCG 2025-1 introduces a formalized form for urgent update requests—but only competent authorities and notified bodies may use it.
👉 Manufacturers cannot submit these directly. Plan ahead and work through regular channels during the annual update cycle.
2. Review of 2024 submissions (MDCG 2025-2)
Outcomes of proposals submitted in 2024:
- Many requests were rejected due to lack of technical or clinical justification.
- Others were partially accepted, leading to new levels or terms (e.g. ablation catheters, arthroscopic tools, urological implant instruments).
👉 Be aware of reclassifications, deleted codes, or renamed terms that may affect your portfolio.
3. A revised annual update process (MDCG 2024-2 Rev.1)
The updated document confirms the annual cycle:
- January: request submission
- February to October: technical evaluation and validation
- November–December: publication of updates on EUDAMED
👉 Submit your proposals before January 31 to be included in the current year’s review.
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4. Expanded FAQ (MDCG 2021-12 Rev.1)
Now includes 24 practical questions, such as:
- Can multiple EMDN codes be assigned to a single UDI-DI?
- What if no code matches my device?
- When must manufacturers update their documents?
👉 Tip: Use of the “99 - Other” suffix is still allowed but will trigger additional review during annual updates.
Key impacts for manufacturers
- Correct classification = safer compliance. Incorrect codes may raise red flags during audits or regulatory reviews.
- Monitor obsolete codes. You’ll need to update EUDAMED and internal documentation before your next surveillance audit.
- Plan ahead. If your device doesn’t fit the current structure, prepare your case for the next submission cycle.
Best practices to implement
- Download the latest EMDN Excel list (MDCG 2025-3).
- Integrate the EMDN update timeline into your QMS.
- Review whether your assigned codes are still valid (especially “99”).
- Involve your consultants and notified body early in product development.
In summary
| Topic | Key Takeaway |
| Ad hoc request form | Reserved for authorities and NBs |
| 2024 request results | Many rejected due to lack of justification |
| Annual procedure | Structured, 4-phase process |
| FAQ | Expanded with 24 practical questions |
| Excel file 2025-3 | The reference for valid EMDN codes |
Mini-FAQ
How do I request a new EMDN code?
👉 Via MDCG 2025-1 form (NBs/Authorities only).
When are EMDN updates released?
👉 Annually in November/December.
Can a device have multiple EMDN codes?
👉 Yes, if justified by multiple intended purposes.
What if my assigned code becomes obsolete?
👉 Update your documentation before your next audit.
Need help navigating EMDN?
At CSDmed, we support medical device manufacturers from classification strategy to EUDAMED registration. Let’s ensure your devices are accurately classified and fully compliant with the latest EMDN updates.