Netherlands · Ministry of Health, Welfare and Sport · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
2 requirements
Application fee
-
The EU rules let a national authority allow a device or IVD on its market without the normal conformity assessment. In the Netherlands such an exemption can be granted with limits and conditions, is announced in the government gazette, and can be withdrawn. A device or IVD needed in the Netherlands that has not completed the required conformity assessment.
1. Request for an exemption; 2. Exemption decision; 3. Announcement in the government gazette.
Outcome: A national exemption, possibly with limits and conditions.
Legal basis: Wet medische hulpmiddelen Articles 8(4) and 9c; Regulation (EU) 2017/745 Article 59; Regulation (EU) 2017/746 Article 54
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).
Official step durations
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 |
|---|---|
| No fees published. |
Other routes in Netherlands: Medical devices and IVDs: Dutch registration, language and supervision rules, CBG consultation on a medicinal substance in a device. 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 (7 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.