Do custom-made devices (CMD) have to be registered in EUDAMED – and what about cases of vigilance?
What are custom-made products according to the MDR? Please also read our article Customization according to MDR (2017/745)
The question of whether “custom-made devices” must be registered in the EUDAMED often reaches us and also causes some confusion with regard to cases of vigilance. Therefore, we would like to provide clarity in our news today and address the following topics:
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What are the obligations of custom-made medtech manufacturers?
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Do they need to be registered as UDI?
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Do Viligance data need to be reported?
What are the basic obligations for custom-made products?
These obligations apply IN FULL:
- CE marking and conformity assessment according to MDR
- Create technical documentation and keep it up to date
- Perform clinical evaluation (adapted to individual production)
- Establish post-market surveillance
- Vigilance obligations in the event of serious incidents
- Risk management system according to ISO 14971
These obligations do not apply to CMDs:
- Switch on the notified body (except for class III implants)
- Clinical Trials (usually)
- UDI system and EUDAMED device registration
Do custom-made products have to be registered as UDI?
Clear answer: NO
Legal basis:
- MDR Art. 27(1): UDI system applies to “…other than custom-made…”
- MDR Art. 29(4): Registration obligation in EUDAMED expressly excluded for CMDs
What does this practically mean?
| Aspect | Custom-made products | Series products |
|---|---|---|
| Award UDI-DI | Not required | Duty |
| UDI-PI on product | Not required | Duty |
| EUDAMED Device Registration | Not required | Duty |
| Own product identification | Recommended (internal) | Plus UDI |
Practical tip:
Even without a UDI obligation, you should establish an internal product identification – this makes vigilance reports and post-market surveillance much easier.
Do vigilance data need to be reported?
Clear answer: Yes, completely!
Legal basis:
- MDCG 2024-11, Q6: Manufacturers who only place custom-made products on the market must register in the Act module in order to be able to report a serious incident, for example.
- MDCG 2021-3 (Custom-made Q&A), para. 8: “With the absence of stated exceptions, CMD manufacturers must meet nearly all of the MDR requirements…” incl. Vigilance notifications pursuant to Art. 87(1).
Vigilance obligations apply to CMDs as well as to series products:
Reporting obligations in detail:
Serious incidents (MIR)
- Deadline for notification: 15 calendar days after becoming aware
- Where: EUDAMED Vigilance module (after roll-out) or nationally
- What: Death, serious health deterioration, danger
Report Trends
- When: In case of an accumulation of non-serious incidents
- Assessment: Continuous monitoring required
Field Safety Corrective Actions (FSCA)
- In case of: Recalls, warnings, software updates
- Publication: About EUDAMED (Field Safety Notice)
Special feature: Actor registration required
No vigilance message possible without SRN!
- CMD manufacturers only need to register as an actor in EUDAMED for vigilance purposes
- Timing critical: registration BEFORE the first message
- Unique: SRN remains for all future reports
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