Pure Global AI
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
Run the classification agent

Everything we track for Netherlands

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.

Changes after registration

Explore questions and sources →

Common questions about changing a registered medical device in Netherlands. Each question separates published rules from details still awaiting verification.

Structured regulatory requirements

Explore all 45 source-linked facts →

23 of 25 research dimensions currently covered · 34 official sources · latest verification 2026-10-21

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
Open details →
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
Open details →
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
Open details →
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
Open details →
D05

Registration pathways

Verified
Update the affected actor record
Manufacturers, authorised representatives and importers register under their actual role before placing devices on the market, subject to the regulation’s scope. Changed registered actor da…
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…
3 source-linked facts
Checked 2026-10-21
Open details →
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
Open details →
D07

Economic-operator roles

Verified
Document a real authorised-representative handover
If the authorised representative changes, the manufacturer, incoming representative and, where practicable, outgoing representative agree the end/start of mandates, last date for the former…
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…
2 source-linked facts
Checked 2026-10-21
Open details →
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
Open details →
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
Open details →
D10

Official forms & portals

Verified
Dutch CFS uses actual regime, identity and supporting documents
For an eligible Netherlands manufacturer or authorised representative requesting a CFS, use NOTIS with eHerkenning 2+ and the actual MDR, IVDR or eligible directive branch. The ordinary cer…
Report Dutch and foreign address changes through their actual route
For a name/address change within the Netherlands, report it to the Chamber of Commerce. Address changes pass from the trade register to NOTIS and may take time; for a notification or CFS re…
3 source-linked facts
Checked 2026-10-21
Open details →

Submission & evidence

D11

Label, IFU & language

Verified
Align the changed identity in labels and declaration
For devices conforming under MDR or IVDR, labels identify the device name/trade name and the manufacturer’s registered name or trademark and business address, with the non EU manufacturer’s…
Dutch IVD information and the professional-use exception
Manufacturer information for an IVD is supplied in Dutch. It may be in English only where use is exclusively by a healthcare professional who has an adequate command of English. The specifi…
5 source-linked facts
Checked 2026-10-21
Open details →
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
Open details →
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
Open details →
D15

Review clocks

Unresolved
Class I · Self-declaration (no notified body)
0 days
1 maintained pathway · 1 related fact
Checked 2026-08-29
Open details →
D16

Approval validity & renewal

Verified
Separate already lawfully placed legacy units
Qualifying devices lawfully placed under the relevant directive or legacy transition may continue to be made available or put into service. Further legacy placing is subject to the actual c…
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…
2 source-linked facts
Checked 2026-10-21
Open details →

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…
Existing IVD NOTIS mutations have a limited window
Confirmed product notifications not yet processed in EUDAMED can still be changed, converted or deregistered online in NOTIS through 27 November 2026 using eHerkenning. Farmatec states a ma…
6 source-linked facts
Checked 2026-10-21
Open details →
D18

UDI, listing & traceability

Verified
Assess the actual REF, model and UDI consequence
A new UDI DI is required for a change that could cause device misidentification or ambiguity in traceability, including a changed device name/trade name or version/model. New UDI data must…
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…
2 source-linked facts
Checked 2026-10-21
Open details →
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
Open details →
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
Open details →
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
Open details →
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
Open details →
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
Open details →
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
Open details →
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
Open details →

Government fees

Full fee schedule (2 lines) →

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

Fee lineAmountProvenance
National device-notification feeEUR 200Verified
Free-sale / export certificateEUR 62Verified

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

Class / pathwayReview clockPlanning totalProvenance
Class I(Self-declaration (no notified body))

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

0 days6-9 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(0 days)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

All Netherlands regulation news →

Newest official IGJ headlines from the daily-refreshed feed — every row links directly to the authority publication.

Nov 10HAHealth and Youth Care Inspectorate (IGJ)Funke Medical Issues FSN for Mattress Extension Regarding Regulatory Classification and LabelingNetherlandsNov 5HAHealth and Youth Care Inspectorate (IGJ)BS Medical Tech Recalls IMP Innoflex Mono Ureteral Stents Over Sterile Packaging Barrier FailureNetherlandsOct 29HAHealth and Youth Care Inspectorate (IGJ)IGJ Issues Safety Notice for STAXS DOTCH Puru Syringes Due to Particulate ContaminationNetherlandsOct 29HAHealth and Youth Care Inspectorate (IGJ)IGJ Issues Safety Notice for Olympus Monopolar and Bipolar HF Cables Following Thermal IncidentNetherlandsOct 29HAHealth and Youth Care Inspectorate (IGJ)IGJ Publishes FSN for Stryker Spine ES2 Spinal System Nitinol K-Wire Blunt Due to Fracture RiskNetherlands
Continue with this market

Turn Netherlands research into practical work

The target market is carried into each tool. Add the product, evidence, or regulatory change you want to assess.

View every AI workpaper →

Build a reusable product master

Structure company, product, model, approval, certificate, and evidence facts before starting Netherlands work.

Netherlands market-launch workpaper

Connect the IGJ route, evidence, labels, local role, timing, and dependencies to a wider launch plan.

Netherlands dossier reuse and delta

Compare an existing authorization and evidence set against IGJ administrative, testing, labeling, and dossier needs.

Netherlands change notification workpaper

Map a product or manufacturing change to IGJ evidence, notification, timing, and implementation questions.

Netherlands regulatory change impact

Assess a current IGJ update against one product and turn it into an owner-ready action workpaper.

Netherlands cybersecurity evidence review

Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Netherlands (IGJ).

Country hubs in other markets

Other Europe markets

AlbaniaArmeniaAustriaAzerbaijanBelarusBelgiumBosnia and HerzegovinaBulgariaCroatiaCyprusCzech RepublicDenmarkEstoniaEuropean UnionFinlandFranceGeorgiaGermanyGreeceHungaryIcelandIrelandItalyKazakhstanLatviaLiechtensteinLithuaniaLuxembourgMaltaMoldovaMontenegroNorth MacedoniaNorwayPolandPortugalRomaniaRussiaSerbiaSlovakiaSloveniaSpainSwedenSwitzerlandTurkeyUkraineUnited KingdomAll 156 markets →
DJ Fang
Entering the Netherlands market?
Local representation, IGJ submissions, and lifecycle maintenance — handled with an expert.
Pricing