IGJ · Europe

Netherlands medical device regulatory resources

Every Netherlands dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

5 free resources23/25 topics with recordsAug 2026 fees reviewed

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Medical device regulation news

Follow recent CIBG/Farmatec; Health and Youth Care Inspectorate for supervision policy, guidance, safety, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary Farmatec risk class with official rule references.

Government registration fees

Review current Farmatec application, review, and renewal fees.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other the Netherlands requirements.

Registration timeline

Compare the statutory notified-body conformity assessment clock under Regulation (EU) 2026/977 with realistic CE marking times by device class.

Structured regulatory requirements

Explore all 32 source-linked facts →

23 of 25 research dimensions currently covered · 29 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified

Competent authority (national role split): The Minister of Health, Welfare and Sport (VWS) is the national responsible authority for notified bodies (including designation, suspension and withdrawal) and appoints the competent autho…
Market surveillance and supervision authority: The inspectors of the Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd, IGJ) are charged with supervising compliance with the Wet medische hulpmiddelen and the obligat…

2 source-linked facts

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

National implementation framework: nationalAct: Wet medische hulpmiddelen (BWBR0042755, law of 24 October 2019) — competent authorities, supervision, tariffs, exemptions, enforcement · implementationDecree: Besluit medische…

1 source-linked fact

Checked 2026-08-25

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D03

Device definition & scope

Verified

Device definition (MDR Art. 2(1)): A medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human b…

1 source-linked fact

Checked 2026-08-29

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D04

Classification rules

Verified

EU MDR classes I, Is, Im, Ir, IIa, IIb and III: Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III

1 maintained scheme

Checked 2026-08-26

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D05

Registration pathways

Verified

Market-access route or official registration surface: submissionSurface: EUDAMED (mandatory from 28 May 2026 under Besluit (EU) 2025/2371) is the registration surface for devices; the national NOTIS system (Farmatec) continues for the Dutch no…
National notification duty (notificatieplicht): The Netherlands maintains a national notification duty for devices and IVDs first placed on the market by a manufacturer or authorised representative established in the Netherlands, coverin…

2 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

NMPA certificate does not replace EU conformity assessment: statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and proce…
EU CE under MDR/IVDR — single market validity: target: geo:nld · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…

2 source-linked facts

Checked 2026-09-15

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D07

Economic-operator roles

Verified

Who bears the national notification duty: The Dutch notification duty falls on a manufacturer established in the Netherlands or on an authorised representative established in the Netherlands representing a non EU manufacturer; impo…

1 source-linked fact

Checked 2026-08-25

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D08

Establishment, import & distribution

Verified

Economic operator registration (EUDAMED): Manufacturers, authorised representatives and importers must register through the electronic system (EUDAMED) and provide the Annex VI Part A Section 1 information before placing devices, o…

1 source-linked fact

Checked 2026-08-29

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D09

Dossier requirements

Verified

Technical documentation (Annexes II and III): The technical documentation required to demonstrate conformity with the general safety and performance requirements must be drawn up in accordance with Annex II to Regulation (EU) 2017/745…

1 source-linked fact

Checked 2026-08-29

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D10

Official forms & portals

Verified

Official form or portal surface: submissionSurface: NOTIS (https://hulpmiddelen.farmatec.nl, login with eHerkenning level 2+) for national notifications, custom made device registration, export certificate applications and…

1 source-linked fact

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

Dutch language requirement for manufacturer information: The information to be supplied by the manufacturer and the general summary (as required by the MDR/IVDR) must be drawn up in Dutch.
English permitted for professional-only devices: By way of exception, the information may be drawn up in English if the device is intended to be used exclusively by a healthcare professional, on the condition that that professional has an…

3 source-linked facts

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

Manufacturer quality management system (Art. 10(9)): Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effe…

1 source-linked fact

Checked 2026-08-29

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D13

Standards, testing & ancillary approvals

Unresolved

MDR electrical safety in place of the Low Voltage Directive: Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive: EMC
Besluit radioapparaten 2016 conformity: Wireless / radio

8 maintained overlays

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D14

Fees

Verified

National device-notification fee: EUR 200
Free-sale / export certificate: EUR 62

2 maintained fee lines · 1 related fact

Checked 2026-08-25

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D15

Review clocks

Unresolved

Class I · Self-declaration (no notified body): 0 days

1 maintained pathway · 1 related fact

Checked 2026-08-29

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D16

Approval validity & renewal

Verified

Certificate validity and renewal (Art. 56(2)): EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be…

1 source-linked fact

Checked 2026-08-29

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Lifecycle & post-market

D17

Change control

Verified

Notification changes and deregistration: Changes to an existing notification (wijziging) and deregistrations (afmelding) are handled by Farmatec with a maximum processing time of 3 months; notifications already in NOTIS but not ye…

1 source-linked fact

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

Official UDI or listing surface: submissionSurface: EUDAMED UDI/Device registration module is the official device listing surface, mandatory from 28 May 2026 (Besluit (EU) 2025/2371); devices already on the EU market befor…

1 source-linked fact

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

CCMO as national competent authority for investigations: The Central Committee on Research Involving Human Subjects (CCMO) is the (sole) competent authority in the Netherlands for clinical investigations with medical devices and performance studi…
Transition for pre-2021 WMO opinions: A positive WMO opinion issued before 26 May 2021 for a clinical investigation under the old directives is treated as a positive opinion for scientific research with medical devices under th…

2 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

National exemption route (MDR art. 59 / IVDR art. 54): An exemption from the requirements of MDR art. 59(1) / IVDR art. 54(1) can be granted by the Minister of VWS on the basis of art. 8(4) Wet medische hulpmiddelen in combination with art. 4(2…
National permission for reprocessing single-use devices: The Netherlands permits reprocessed single use medical devices to be offered on the market only if they comply with the requirements set by or under the Wet medische hulpmiddelen; the Beslu…

2 source-linked facts

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Interim channel for PSUR and trend reports: Until all EUDAMED modules are functional, manufacturers send their reports on serious incidents, FSCA with field safety notice (FSN), periodic summary reports (PSUR) and trend reports to th…

1 source-linked fact

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

National vigilance reporting channel: Until EUDAMED vigilance reporting becomes mandatory, manufacturers and authorised representatives report serious incidents to the IGJ using the MIR form (Manufacturer Incident Report), sent…

1 source-linked fact

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

FSCA reporting channel: Field safety corrective actions (FSCA) with the field safety notice (FSN) are reported to the IGJ using the FSCA form, sent by email to meldpunt@igj.nl (as PDF attachment), until EUDAMED is…
Ministerial public-health measures: The Minister of VWS is empowered to take the special measures for the protection of public health referred to in MDR art. 98(1) (and the IVDR equivalent), such as requiring recall or withdr…

2 source-linked facts

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Prohibition of gunstbetoon (sales inducements): Suppliers of medical devices are prohibited from promising, offering or granting benefits (gunstbetoon) to promote sales, with statutory exceptions (e.g. participation costs, services, bene…
Criminal penalty for violating MDR/IVDR art. 7: Acting in violation of art. 7 of Regulation (EU) 2017/745 or art. 7 of Regulation (EU) 2017/746 (misleading claims) is a criminal offence in the Netherlands, punishable by imprisonment of a…

2 source-linked facts

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Appeal and objection routes for device investigations: Decisions on clinical investigations with medical devices can be challenged through national routes: administrative appeal to the CCMO against a decision of an accredited MREC (medical rese…

1 source-linked fact

Checked 2026-08-25

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Government fees

Full fee schedule (2 lines) →

Farmatec (CIBG) registration fees in EUR · reviewed 2026-08-25

Fee line	Amount	Provenance
National device-notification fee	EUR 200	Verified
Free-sale / export certificate	EUR 62	Verified

Registration timeline

Full registration timeline →

Health and Youth Care Inspectorate (IGJ), with CIBG/Farmatec registration desks (IGJ) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU MDR classification