Netherlands Medical Device Registration & Market Access Guide (2026): IGJ, CIBG Farmatec, NOTIS, EUDAMED & Requirements

Overview of the Netherlands' Medical Device Market

The Netherlands is one of Europe's most important medical device markets and a critical gateway to the EU. With medical device exports of approximately €33.9 billion and imports of approximately €27.2 billion in 2024, the Netherlands runs one of the largest medical device trade surpluses in Europe (approximately €6.7 billion), according to MedTech Europe. The country serves as both a major manufacturing hub and a distribution gateway, leveraging the Port of Rotterdam (Europe's largest port) and Schiphol Airport to connect manufacturers across the continent.

Dutch expenditure on medical products is projected to reach approximately €5.4 billion by 2028, growing at an average annual rate of 3.5% from approximately €4.3 billion, according to ReportLinker data. Total healthcare spending in the Netherlands reached €113.5 billion in 2024, representing 10.0% of GDP — among the highest in the EU per capita (€5,871 per capita in 2023, third behind only Germany and Austria, per Statistics Netherlands/CBS).

The Netherlands is home to Koninklijke Philips N.V., one of the world's largest medical technology companies, and hosts a dense ecosystem of medical device companies, European Authorized Representatives (ARs), and Notified Bodies. As of 2024, 347 Authorized Representatives are registered in the Dutch national database NOTIS, making the Netherlands one of the most popular EU member states for AR establishment.

A landmark development for 2026: the EUDAMED mandatory registration deadline on 28 May 2026 will fundamentally change how devices are registered, adding an EU-wide registration layer on top of the existing national NOTIS system.

Key Market Data

Metric	Value
Medical device exports (2024)	~€33.9 billion
Medical device imports (2024)	~€27.2 billion
Healthcare spending (2024)	€113.5 billion (10.0% of GDP)
Healthcare spending per capita (2023)	€5,871 (3rd in EU)
Medical product expenditure (proj. 2028)	~€5.4 billion
Population	~18 million
Authorized Representatives in NOTIS	347
Dutch Notified Bodies (MDR)	4
EUDAMED mandatory registration	28 May 2026

Regulatory Framework

As an EU member state, the Netherlands does not operate a standalone national approval system for most medical devices. Instead, devices are regulated primarily under EU-wide legislation supplemented by national implementing laws. However, the Netherlands maintains a national notification system (NOTIS) for specific device categories and exercises robust market surveillance through its competent authority.

EU-Level Legislation

Regulation	Purpose
Regulation (EU) 2017/745 (MDR)	Primary legislation for medical devices — classification, conformity assessment, CE marking, clinical evidence, post-market surveillance
Regulation (EU) 2017/746 (IVDR)	Primary legislation for in vitro diagnostic medical devices
EUDAMED	European Database on Medical Devices — mandatory from 28 May 2026

National Legislation

The Netherlands has implemented the MDR and IVDR through several layers of national law:

Law / Decree	Dutch Name	Key Provisions
Medical Devices Act	Wet medische hulpmiddelen (Wmh)	Code of conduct, fees and fines, IGJ competencies, clinical investigation provisions
Medical Devices Decree	Besluit medische hulpmiddelen	Implant card requirements, National Implants Registry (LIR), reprocessing of single-use devices
Medical Devices Rule	Regeling medische hulpmiddelen	Language requirements, Certificate of Free Sale, additional national registration rules

Key Regulatory Bodies

Body	Role
Ministry of Health, Welfare and Sport (VWS)	Implements MDR in Dutch legislation; represents the Netherlands in MDCG; designates Dutch Notified Bodies
Health and Youth Care Inspectorate (IGJ)	Competent authority for market surveillance; supervises compliance; monitors Notified Bodies; oversees vigilance reporting and field safety corrective actions
CIBG / Farmatec	Administrative body responsible for processing national device registrations via NOTIS; issues Certificates of Free Sale
Medicines Evaluation Board (MEB / CBG)	Competent authority for medicinal products; handles consultation procedures for drug-device combination products
Central Committee on Research Involving Human Subjects (CCMO)	Sole competent authority for clinical investigation registrations with medical devices (since October 2020)

Device Classification

The Netherlands follows the EU MDR classification system for medical devices and the IVDR classification system for in vitro diagnostics. There is no separate Dutch classification scheme.

Medical Devices (MDR)

Class	Risk Level	Examples	Conformity Assessment
Class I	Low	Bandages, manual wheelchairs, surgical instruments (non-reusable)	Self-assessment by manufacturer (except sterile, measuring, reusable surgical instruments)
Class IIa	Low-Medium	Hearing aids, ultrasound physiotherapy equipment, surgical masks	Notified Body involvement required
Class IIb	Medium-High	Ventilators, surgical lasers, implantable pacemakers (some), X-ray equipment	Notified Body involvement required
Class III	High	Heart valves, implanted pacemakers, prosthetic joints, spinal cages	Notified Body involvement (full quality assurance + design examination)

Special Class I sub-categories that require Notified Body involvement:

• Class Is — sterile Class I devices (e.g., sterile dressings)
• Class Im — Class I devices with a measuring function (e.g., graduated measuring cups)
• Class Ir — reusable surgical instruments (e.g., reusable scalpels)

IVDs (IVDR)

Class	Risk Level	Examples	Conformity Assessment
Class A	Low	General laboratory reagents, specimen collection devices	Self-assessment
Class B	Low-Moderate	Self-testing pregnancy tests, Vitamin B12 tests	Notified Body required
Class C	Moderate-High	Blood glucose self-testing, HLA typing, genetic tests	Notified Body required
Class D	High	HIV blood screening, blood grouping for transfusion	Notified Body required + EU reference lab

National Registration Requirements (NOTIS)

While CE marking is EU-wide, the Netherlands requires additional national registration for certain device categories through the NOTIS online system, administered by CIBG Farmatec.

Who Must Register

National registration (notification) is mandatory for:

Who	What
Dutch manufacturers	Class I medical devices placed on the EU market
Netherlands-based Authorized Representatives of non-EU manufacturers	Class I medical devices placed on the EU market
Dutch manufacturers or their ARs	Custom-made medical devices
Dutch manufacturers or their ARs	Systems or procedure packs
Dutch manufacturers or their ARs	All IVDs (all risk classes)

Important: Class IIa, IIb, and III medical devices (i.e., those requiring Notified Body assessment) do not require separate national registration in NOTIS — they are covered through the EU CE marking system and, from May 2026, through EUDAMED.

Registration Process

1. Obtain eRecognition token: You need a Level 2+ eRecognition token (eHerkenning) from one of 6 recognized Dutch issuers. Your company must be entered in the Dutch Commercial Register (KVK) and have an establishment number.
2. Access NOTIS: Log into the NOTIS portal at english.farmatec.nl
3. Submit notification: Complete the online notification with required documents
4. CIBG processing: CIBG reviews the submission for completeness

Required Documents

• Declaration of Conformity (issued by the manufacturer for Class I devices and IVDs)
• CE certificate (if applicable — for Class Is, Im, Ir, and higher classes)
• Product information (description, classification, intended purpose)
• Labeling and instructions for use

Registration Timeline

• Class I devices and Class A IVDs: Approximately 4–6 weeks after submission
• Other classes: Depends on the Notified Body contract and device type (typically 6–18 months for Class IIa through III)

License Validity

EU CE certificates are generally valid for 5 years (subject to annual surveillance audits and renewal by the Notified Body).

EUDAMED Registration

The European Database on Medical Devices (EUDAMED) is the EU-wide registration system that becomes mandatory on 28 May 2026 for several key modules.

EUDAMED Timeline

Date	Obligation
27 November 2025	EUDAMED Modules 1, 2, 3, and 6 declared functional
28 May 2026	Mandatory registration of new MDR/IVDR devices; Notified Bodies begin uploading new certificates
27 November 2026	Mandatory registration of legacy (MDD/AIMDD/IVDD) devices
28 May 2027	NBs complete uploading certificates issued before May 2026
TBD	Vigilance and Clinical Investigation modules become mandatory

EUDAMED Modules

Module	Content	Status
Module 1: Actor Registration	Manufacturers, ARs, importers, sponsors — requires Single Registration Number (SRN)	Mandatory from May 2026
Module 2: UDI/Device Registration	All device data and Unique Device Identifiers	Mandatory from May 2026
Module 3: Notified Bodies & Certificates	NB details and issued certificates	Mandatory from May 2026
Module 4: Clinical Investigations	Registration and management of clinical studies	Under development
Module 5: Vigilance & Post-Market Surveillance	Incident reporting, FSCAs, trend reports	Under development
Module 6: Market Surveillance	Coordination between national authorities	Mandatory from May 2026

Obtaining an SRN

To access EUDAMED, manufacturers, authorized representatives, and importers need a Single Registration Number (SRN). In the Netherlands, the CIBG acts as the competent authority for SRN verification. The CIBG will approve your application once the entered data is complete and correct, and EUDAMED will then grant you an SRN.

Note: If you are both a manufacturer and an importer, you need a separate SRN for each role.

NOTIS vs. EUDAMED

With EUDAMED becoming mandatory, the relationship between NOTIS and EUDAMED is evolving:

• MDR-compliant devices (Class I, procedure packs, IVDs): The Dutch government encourages registration in EUDAMED. If you choose not to register in EUDAMED, you are required to complete national registration in NOTIS.
• Custom-made devices: Must always be registered in NOTIS, except for Class III implantable custom-made devices — these must be registered in EUDAMED.
• Legacy MDD/IVDD devices: Existing MDD-compliant notifications must either be entered in EUDAMED or temporarily amended in NOTIS until EUDAMED is fully operational.

IVDD Legacy Device Transition in NOTIS

IVDs that were certified under the IVDD (with a conformity declaration before 26 May 2022 and placed on the market before that date) can continue to be registered in NOTIS during the transition period, subject to the following conditions:

Requirement	Class D	Class C	Class A Sterile / B
QMS per IVDR Art. 10(8) in place	By 26 May 2025	By 26 May 2025	By 26 May 2025
Formal NB conformity assessment request	By 26 May 2025	By 26 May 2026	By 26 May 2027
Written NB agreement signed	4 months after above date	4 months after above date	4 months after above date
NOTIS registration valid until	26 May 2027	26 May 2028	26 May 2029

Additional conditions: no significant modifications to the device, and continued IVDD compliance.

Custom-Made Device Registration

Custom-made medical devices have specific NOTIS registration requirements:

• No CE marking is applied to custom-made devices
• No UDI is required
• The label must include the wording "Custom-made medical device" (Dutch: Hulpmiddel naar maat)
• Registration in NOTIS is by product category (not individually per device) — a general declaration covering categories of custom-made devices is acceptable
• Class III implantable custom-made devices require Notified Body involvement and must be registered in EUDAMED
• The declaration must include: manufacturer name and address, authorized representative details (if applicable), device identification means, and a statement that the device is exclusively intended for a specific patient

Dutch Notified Bodies

The Netherlands is home to four Notified Bodies designated under the MDR — one of the highest concentrations in any EU member state. This makes the Netherlands an especially important country for CE marking across the EU.

Notified Body	NB Number	Headquarters	MDR Scope	Key Services
BSI Group The Netherlands B.V.	2797	Amsterdam	Full scope (MDR + IVDR)	Leading NB, extensive international reach
DEKRA Certification B.V.	0344	Waardenburg/Rijswijk	Full scope (MDR + IVDR)	Part of global DEKRA network; offices in many countries
Kiwa Assurance B.V. (formerly Kiwa Dare)	1912	Geldermalsen	MDR + IVDR	Specializes in EMC testing; IEC 60601 accredited
Scarlet NB B.V.	3022	Netherlands	MDR	Newer NB, growing scope

Notified Body Fee Comparison (2025–2026)

The following fee data comes from published Notified Body price lists and the European Commission's compiled NB fee references:

Notified Body	Audit Costs	Technical Documentation Review	Annual Fee
DEKRA Certification B.V. (NB 0344)	€320/hr (€2,560/day)	€450/hr (€3,600/day)	€2,300
Kiwa Assurance B.V. (NB 1912)	€300/hr (€2,400/day)	€400/hr (€3,200/day)	€2,750
BSI Group The Netherlands (NB 2797)	€2,185/day	€3,790/day	€2,375–€9,975
Scarlet NB B.V. (NB 3022)	€3,000/day	€3,000–€4,100/day	Varies

Note: Fees depend heavily on device classification, complexity, and the number of products. A Class IIa technical file review may take 6–8 days; a Class III review can take significantly longer. Always request a formal quote from your chosen NB.

IGJ Oversight of Notified Bodies

The IGJ is responsible for monitoring the Dutch Notified Bodies. This monitoring includes:

• Annual monitoring plans reviewed by the European Commission and MDCG
• Joint inspections with other EU member state authorities
• Assessment of NB compliance with MDR/IVDR requirements

CE Marking & Conformity Assessment

Step-by-Step Conformity Assessment Process

Step 1 — Classify your device using MDR Annex VIII (or IVDR Annex VIII for IVDs). Classification determines the conformity assessment route.

Step 2 — Implement a Quality Management System (QMS) compliant with ISO 13485 and MDR Article 10. The QMS must address risk management, clinical evaluation, post-market surveillance, and serious incident reporting.

Step 3 — Prepare Technical Documentation per MDR Annex II and III. This includes:

• Device description and specification
• Information supplied by the manufacturer (labeling, IFU)
• Design and manufacturing information
• General Safety and Performance Requirements (GSPR)
• Benefit-risk analysis and risk management
• Product verification and validation
• Pre-clinical and clinical data (Clinical Evaluation Report)

Step 4 — Select a Notified Body (for Class IIa and above, plus Class Is/Im/Ir). Choose from any EU-designated NB — you are not restricted to Dutch NBs.

Step 5 — Undergo conformity assessment. The route depends on device class:

Class	Conformity Assessment Route
Class I (standard)	Self-declaration (Annexes IV, V, VI, VII — internal production control)
Class Is, Im, Ir	Annex IX (QMS) or Annex XI (product conformity) + NB
Class IIa	Annex IX (QMS) or Annex XI (product conformity) + NB
Class IIb	Annex IX (full QMS) or Annex X + XI (technical file + product verification) + NB
Class III	Annex IX (full QMS with design examination) + NB

Step 6 — Draw up the EU Declaration of Conformity and affix the CE marking to the device, its packaging, and the IFU.

Step 7 — Register in EUDAMED (from May 2026) and NOTIS (if applicable for Class I/IVD/custom-made).

Language Requirements

The Netherlands requires specific language accommodations for medical devices sold in the Dutch market:

Document	Language Requirement
Device labels	Dutch or Dutch + other EU languages
Instructions for Use (IFU)	Must be in Dutch
Declaration of Conformity	Any EU language (typically English)
Clinical investigation documents	Dutch (for patient-facing materials); English accepted for technical submissions to CCMO
Promotional materials	Dutch

This is a key consideration: if your IFU is only in English or German, you must provide a Dutch translation before placing the device on the Dutch market.

Clinical Investigations

Regulatory Framework

Clinical investigations with medical devices in the Netherlands are governed by MDR Chapter VI (Articles 62–82) and the Dutch Medical Devices Act. Since 1 October 2020, the CCMO (Centrale Commissie Mensgebonden Onderzoek) has been the sole competent authority for all clinical investigation registrations — a function previously held by the IGJ.

Two Types of Clinical Investigation

Type	MDR Article	Description	Approval Required
Article 62 investigations	Art. 62	Full clinical investigation for new devices or new intended uses	Yes — full approval from CCMO/MREC + competent authority
Article 82 investigations	Art. 82	Post-market clinical follow-up with CE-marked device used within intended purpose	Notification only (less restrictive)

When Clinical Investigations Are Required

Clinical investigations are generally required for:

• Class III and implantable Class IIb devices (new devices without sufficient existing clinical data)
• Any device where clinical data is insufficient to demonstrate safety and performance
• Devices with a new intended purpose outside the scope of CE marking

For lower-risk devices, clinical evaluation may be based on literature review, bench testing, or simulated use without a full clinical investigation.

Application Process

1. Prepare research file: Clinical Investigation Plan (CIP), investigator's brochure, patient information, consent forms, risk analysis
2. Submit to CCMO: Via the CCMO online portal (ToetsingOnline)
3. Ethics review: An accredited Medical Research Ethics Committee (MREC) or CCMO reviews the file
4. Competent authority notification: CCMO processes the registration
5. Approval: Wait for written approval before starting recruitment
6. Report SAEs: Serious Adverse Events reported to CCMO

CCMO Fees for Clinical Investigations (2026)

Type of Assessment	Commercial Research	Non-Commercial Research
National research (incl. MS-specific documents)	€8,010	€2,670
IMDD / Product information (per unregistered product)	€2,655	€885
Substantial amendment (MS-specific changes)	€663	€221
Substantial amendment (other changes)	€2,025	€675
Substantial amendment (both)	€2,655	€885

Source: CCMO Rates 2026, published by the Ministry of Health, Welfare and Sport.

Clinical Investigation Timelines

• Initial review: Typically 45–60 days for MREC/CCMO assessment
• Competent authority decision: Within the MDR-specified timelines
• Start of recruitment: Only after written approval from MREC/CCMO and site approval

Drug-Device Combination Products

The Netherlands has a specific consultation procedure for drug-device combination products through the MEB (Medicines Evaluation Board). When a medical device incorporates a medicinal product as an integral part, the MEB must be consulted on the medicinal substance aspect.

MEB Consultation Fees (2026)

Application Type	Fee 2026
New use of a medicinal product in a medical device	€46,100
Known use of a medicinal product in a medical device	€25,830
Change in the use of a medicine in a medical device (Type IA)	€730
Change in the use of a medicine in a medical device (Type IB)	€2,880
Type II change in the use of a medicine in a medical device	€17,450
Reconsultation of medical devices	€730
Transfer to MEB as competent authority for a medical device	€17,450
Substance-based medical device	€28,750

Source: MEB Fee Schedule 2026.

Authorized Representatives

The Netherlands is one of the most popular EU member states for Authorized Representative (AR) establishment, with 347 ARs registered in NOTIS. This popularity is driven by:

• Pro-business regulatory environment
• Central European location
• English-language proficiency
• Presence of major Notified Bodies (BSI, DEKRA, Kiwa)

AR Requirements (MDR Article 11)

Under the MDR, an EU Authorized Representative is mandatory for all manufacturers based outside the EU. The AR must:

• Be established in the EU (with a physical address — not just a P.O. box)
• Have a written mandate from the manufacturer specifying the device families covered
• Keep copies of technical documentation, Declaration of Conformity, and CE certificates available
• Serve as the contact point for competent authorities
• Report serious incidents to national authorities

IGJ Compliance Findings

A 2024 inspection by the IGJ found that more than one-third of Authorized Representatives in the Netherlands had yet to fully meet all MDR and IVDR requirements. Key issues included:

• Insufficient mandates between AR and manufacturer
• Lack of physical presence (P.O. box-only addresses)
• Mandates not clearly listing device families
• Inadequate documentation retention

Takeaway: If you select a Netherlands-based AR, verify their actual compliance status and ensure the mandate agreement meets MDR Article 11(3) requirements.

Post-Market Surveillance & Vigilance

PMS Obligations

The IGJ has actively enforced post-market surveillance requirements. In inspections during 2023 and 2024, the IGJ found that none of 13 manufacturers inspected fully met the PMS requirements set by the MDR and IVDR. Key deficiencies included:

• Inadequate integration of PMS into quality management systems
• Insufficient documentation
• Lack of systematic data collection and analysis

Required PMS Documentation

Document	Applies To	Frequency
PMS Plan	All devices	Updated as needed
PMS Report	Class I	As needed (at minimum, upon request)
Periodic Safety Update Report (PSUR)	Class IIa, IIb, III	Annually (IIa) or at least annually (IIb/III)
Trend Report	All devices (if trends identified)	As needed
PMCF Evaluation Report	Class IIa, IIb, III	Per PMCF plan

Vigilance Reporting

Event Type	Reporting Deadline	Report To
Serious incident	Immediately, no later than 15 days	IGJ (until EUDAMED Vigilance module is operational)
Serious public health threat	Immediately, no later than 2 days	IGJ
Death or unanticipated serious deterioration	Immediately, no later than 10 days	IGJ
Field Safety Corrective Action (FSCA)	Immediately upon decision	IGJ

Until the EUDAMED Vigilance module (Module 5) becomes functional, manufacturers must continue reporting directly to the IGJ.

Implant Requirements

The Netherlands has specific additional requirements for implantable devices:

1. Implant Card: Manufacturers must supply an implant card with information about the implant and the manufacturer.
2. Patient Recording: If implants are supplied directly to patients, the patient's details must be stated on the implant card and the data recorded in the patient's electronic patient record (EPR).
3. National Implants Registry (LIR): Implants must be registered in the Dutch Landelijk Implantaten Register (LIR) within 1 month of implantation.
4. Adverse Effects Reporting: Side effects of implants must be reported to the Dutch Reporting Centre for Adverse Effects of Medical Implants (MEBI).

Certificates of Free Sale

Dutch manufacturers and Netherlands-based ARs can request a Certificate of Free Sale (CFS) from CIBG Farmatec. This document certifies that a medical device may be freely traded on the EU market and is often required for registration in non-EU countries.

• Application is made through the NOTIS portal
• Requires a Level 2+ eRecognition token
• Processing time and fees apply

Step-by-Step Market Entry Guide

For EU-Based Manufacturers

1. Classify your device per MDR Annex VIII
2. Implement ISO 13485 QMS and MDR-compliant processes
3. Prepare technical documentation (Annex II/III)
4. Select a Notified Body (if Class Is/Im/Ir or higher)
5. Complete conformity assessment and obtain CE certificate
6. Draw up EU Declaration of Conformity and affix CE marking
7. Register in EUDAMED (mandatory from 28 May 2026)
8. Register in NOTIS (if Class I device, custom-made device, or IVD — for Dutch manufacturers)
9. Ensure Dutch-language IFU and labeling
10. Implement PMS system and vigilance reporting procedures

For Non-EU Manufacturers

1. Complete steps 1–6 above
2. Appoint an EU Authorized Representative — consider a Netherlands-based AR, but verify MDR compliance
3. Register the AR in EUDAMED (SRN required)
4. Register in NOTIS (through your Netherlands-based AR, if applicable)
5. Ensure Dutch-language IFU and labeling for the Dutch market
6. Appoint an EU importer and register in EUDAMED

Estimated Costs and Timelines

Registration Costs

Cost Component	Estimated Range
Notified Body — Class IIa review	€15,000–€40,000
Notified Body — Class IIb review	€25,000–€80,000
Notified Body — Class III review	€50,000–€150,000+
ISO 13485 QMS implementation	$20,000–$60,000
Technical file preparation	$15,000–$80,000
Clinical evaluation report	$10,000–$50,000
EU Authorized Representative (annual)	$2,000–$10,000
CCMO clinical investigation review (2026, commercial)	€8,010+ per study
CIBG Farmatec / NOTIS notification	Minimal administrative fee

Timelines

Activity	Estimated Timeline
NOTIS registration (Class I / IVD)	4–6 weeks
Notified Body assessment (Class IIa)	6–12 months
Notified Body assessment (Class IIb)	9–18 months
Notified Body assessment (Class III)	12–24+ months
Clinical investigation approval (CCMO)	45–60 days (initial review)
EUDAMED actor registration	Days to weeks

Key Contacts and Resources

Resource	URL
IGJ (Health and Youth Care Inspectorate)	english.igj.nl
CIBG Farmatec (NOTIS registration)	english.farmatec.nl
CCMO (clinical investigations)	english.ccmo.nl
MEB / CBG (drug-device combinations)	english.cbg-meb.nl
Business.gov.nl (medical device requirements)	business.gov.nl/regulations/medical-devices
EUDAMED	ec.europa.eu/tools/eudamed
European Commission NANDO (NB database)	ec.europa.eu/growth/tools-databases/nando
eRecognition (eHerkenning)	eherkenning.nl

Frequently Asked Questions

Do I need to register my medical device in the Netherlands specifically?

It depends. If your device is Class I, custom-made, a system/procedure pack, or an IVD, and you are a Dutch manufacturer or have a Netherlands-based AR, you must register it nationally in NOTIS. For Class IIa and above, CE marking and EUDAMED registration are sufficient — no separate Dutch registration is needed. However, all devices must be registered in EUDAMED from 28 May 2026.

Can I use a Notified Body from another EU country?

Yes. You can select any EU-designated Notified Body — you are not restricted to Dutch NBs. Many manufacturers choose BSI (Netherlands) or TÜV SÜD (Germany) due to their scope and reputation.

Do instructions for use need to be in Dutch?

Yes. For devices placed on the Dutch market, the instructions for use (IFU) must be available in Dutch. Labels must also include Dutch-language information.

How does EUDAMED affect existing NOTIS registrations?

EUDAMED registration is becoming mandatory alongside national requirements. Check the latest CIBG Farmatec guidance for whether both NOTIS and EUDAMED registration are required for your device category. In general, EUDAMED is intended to eventually replace some national registration functions, but during the transition period, dual registration may be necessary.

What is the role of the IGJ?

The IGJ (Health and Youth Care Inspectorate) is the Dutch competent authority for medical devices. It monitors market compliance, conducts inspections, supervises Notified Bodies, oversees vigilance reporting, and takes enforcement action when devices do not meet requirements.

Can I conduct a clinical investigation in the Netherlands?

Yes. All clinical investigations must be registered with the CCMO. You will need a complete research file including the Clinical Investigation Plan, patient information, consent forms, and product documentation. Both MREC/CCMO ethics approval and competent authority notification are required before recruitment begins.

How long does it take to get a Class I device on the Dutch market?

For a Class I device (self-declared, no Notified Body required), the process can be as fast as 4–6 weeks for NOTIS registration, provided your technical documentation is complete and your QMS is in place. Add additional time for EUDAMED registration, Dutch-language IFU preparation, and PMS system setup.

Key Takeaways

1. The Netherlands is an EU member state — there is no standalone national approval system. CE marking under the MDR/IVDR is the primary regulatory pathway.
2. National registration in NOTIS is required for Class I devices, custom-made devices, systems/procedure packs, and all IVDs (for Dutch manufacturers or Netherlands-based ARs).
3. EUDAMED becomes mandatory on 28 May 2026 — all manufacturers must register actors, devices, and UDI data.
4. Four Dutch Notified Bodies (BSI, DEKRA, Kiwa, Scarlet) make the Netherlands a major CE marking hub.
5. Dutch-language IFU and labeling are mandatory for the Dutch market.
6. Clinical investigations are registered with the CCMO (not the IGJ) — fees start at €8,010 for commercial studies in 2026.
7. IGJ actively enforces PMS compliance — their 2023–2024 inspections found widespread deficiencies. Robust PMS systems are essential.
8. 347 Authorized Representatives are based in the Netherlands, making it one of the most popular AR domiciles — but verify that your chosen AR is fully MDR-compliant following the IGJ's 2024 compliance findings.