Netherlands · Medicines Evaluation Board · Combination products
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
2 requirements
Application fee
€46,100
2026
When a device contains a substance that would be a medicine on its own, the notified body must ask a medicines authority for advice. The CBG can act as that authority. It advises on the quality, safety and benefit-risk of the substance. The notified body decides, but it may not issue a certificate after a negative opinion. Devices with an ancillary medicinal substance (for example drug-eluting stents) and substance-based devices, when the notified body chooses the CBG.
The consultation, new use of a medicinal substance in a device is €46,100 for 2026.
1. Scientific or regulatory advice (optional); 2. Request a time slot (21 days); 3. Notified body submits the consultation; 4. CBG scientific opinion; 5. Notified body decision.
Outcome: A scientific opinion to the notified body.
Legal basis: Regulation (EU) 2017/745 Annex IX section 5.2; Regeling Geneesmiddelenwet Article 7.9
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 21 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Consultation, new use of a medicinal substance in a deviceApplication · 2026 | €46,100 |
| Consultation, substance-based deviceApplication · 2026 | €28,750 |
| Consultation, known use of a medicinal substance in a deviceApplication · 2026 | €25,830 |
| Re-consultation for recertification under the MDRRenewal · 2026 | €17,450 |
Other routes in Netherlands: Medical devices and IVDs: Dutch registration, language and supervision rules, National derogation for a device without completed conformity assessment. See all routes on the Netherlands page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (15 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.