Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Medical devices and IVDs: Dutch registration, language and supervision rules

Netherlands · Health and Youth Care Inspectorate · Medical devices

Device: registration or licence with the regulatorHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

9 requirements

What is the Medical devices and IVDs: Dutch registration, language and supervision rules in Netherlands?

Devices and IVDs follow the EU regulations. Only a few matters, such as supervision and the language of the instructions, are set nationally. Economic operators register in EUDAMED, and for Dutch actors the CIBG/Farmatec checks the request and issues the single registration number. The inspectorate (IGJ) supervises the market and receives incident reports until EUDAMED is ready. Any device, IVD or software device placed on the Dutch market, and manufacturers or importers established in the Netherlands.

How much does the Medical devices and IVDs: Dutch registration, language and supervision rules cost?

The certificate of free sale (per certificate) is €62 for current.

What are the steps of the Medical devices and IVDs: Dutch registration, language and supervision rules?

1. Actor registration and SRN; 2. Conformity assessment under EU rules; 3. Place on the Dutch market with Dutch information; 4. Incident reporting and supervision.

Outcome: Registration number (SRN) for Dutch actors and lawful supply on the Dutch market.

Legal basis: Wet medische hulpmiddelen; Besluit medische hulpmiddelen; Regeling medische hulpmiddelen; Regulations (EU) 2017/745 and 2017/746

Steps

In order, with the official target for each step

1. Actor registration and SRNDutch manufacturers, authorised representatives and importers register in the EUDAMED actor module. CIBG/Farmatec checks uniqueness, completeness and establishment in the Netherlands.
2. Conformity assessment under EU rulesThe registration number is needed to apply to a notified body.
3. Place on the Dutch market with Dutch information
4. Incident reporting and supervisionSerious incidents and field safety actions are reported to the IGJ until EUDAMED is available.

Requirements

What the applicant must provide or meet

Local presence

EUDAMED actor registrationFrom 28 May 2026 economic operators must register centrally in EUDAMED. CIBG/Farmatec checks the request of actors established in the Netherlands.

Language

Dutch information for usersInformation for users and patients is in Dutch. English is allowed for information on devices used only by healthcare professionals with adequate English. Field safety notices and certain documents can be in Dutch or English.

Other

Custom-made devices list(in some cases)Manufacturers of custom-made devices give the Minister a list of the categories they supply in the Netherlands.
Permanent wrinkle fillersUse of a permanent wrinkle filler that stays in the body for life is banned except for reconstructive purposes.
Reprocessing of single-use devices(optional)Reprocessing and further use of single-use devices is allowed under the EU conditions.

After approval

Incident reporting to the inspectorateManufacturers report serious incidents in the Netherlands and field safety corrective actions to the IGJ until EUDAMED is available.
Supply interruption noticesManufacturers send notices of supply interruptions to the CIBG.
Documents kept availableTechnical documentation stays available to the Minister for the required period, even after bankruptcy or end of business.

Labeling

Implant cardHealthcare institutions give patients with an implant an implant card.

Medical devices and IVDs: Dutch registration, language and supervision rules

What is the Medical devices and IVDs: Dutch registration, language and supervision rules in Netherlands?

How much does the Medical devices and IVDs: Dutch registration, language and supervision rules cost?

What are the steps of the Medical devices and IVDs: Dutch registration, language and supervision rules?

How the pathway works

Timeline with clock stops

Steps

Requirements

Local presence

Language

Other

After approval

Labeling

Official time targets

Fees