Netherlands Product Registration & Certification
Important Notes
- National Implementation within EU Framework: Medical devices follow EU MDR/IVDR, supervised by the Medical Devices Unit of the Dutch Medicines Evaluation Board (CBG-MEB); cosmetics follow EU Regulation EC 1223/2009.
- Dutch Language Labeling: Product labels, instructions for use, and patient leaflets must be in Dutch, which can be alongside other EU languages, but the Dutch information must be complete and easily identifiable.
- WIG Registration & Reimbursement: For reimbursement under basic health insurance, medical devices must be registered in the Medical Devices Registry (Wet op de Geneesmiddelen, WIG) of the Dutch Healthcare Authority (NZa), demonstrating necessity, effectiveness, and cost-effectiveness.
- Economic Operator ID & UDI: Economic operators need an SRN from EUDAMED; product UDI data must be submitted to EUDAMED and ensure compatibility with Dutch national coding systems (e.g., GMN).
- Advertising & Professional Promotion: Promotional materials for healthcare professionals must comply with industry codes (e.g., Nefarma, Medtech Nederland); public advertising requires pre-approval by CBG-MEB (for medicines) or strict compliance.
- eHealth & Data Compliance: Digital health products require additional consideration of Dutch Personal Health Environment (PGO) standards, data security laws, and strict local implementation of GDPR.
Netherlands specific Requirements
- Highly Digitalized & Process-Oriented: Regulatory processes are highly digitized, emphasizing transparency, predictability, and evidence-based decision-making; companies must be proficient with government online portals (e.g., Mijn CBG).
- Value-Driven Reimbursement System: Reimbursement decisions heavily rely on Health Technology Assessment (HTA) and cost-effectiveness analysis, provided by the independent National Health Care Institute (Zorginstituut Nederland, ZINL).
- Focus on Integrated Health Solutions: Policy encourages preventive care and integrated care models, benefiting innovative, digital, and home-care (Buurthuiszorg) related products.
- Centralized Distribution Channels: The market is dominated by a few large purchasing groups (e.g., Mediq, Euroma), making partnership strategies with hospitals and purchasing organizations critical.
- Clear Innovation Acceleration Pathways: Flexible early access pathways (e.g., "temporary reimbursement" arrangements) exist for breakthrough innovative devices, with active adoption of EUnetHTA joint clinical assessments.
Medical Devices Registration
Regulatory Requirements
- CE Marking Certification (according to MDR)
- Classification Management per MDR (Class I, IIa, IIb, III)
- Complete Technical Documentation (Dutch/English)
- Clinical Evaluation Report (CER)
- Quality Management System (EN ISO 13485:2016)
- Post-Market Surveillance Plan (PMS)
- Vigilance System Documentation
- European Authorized Representative (EC Rep)
- UDI-DI Code Registration
- Dutch Labeling and Instructions
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Notified Body Assessment
- Conformity Assessment Completion
- EUDAMED Registration
- Market Access Completion
Registration Timeline
12-24 months
Official Fees
€3,000 - €60,000
Service Fees
$20,000 - $65,000
Regulatory System Overview
IGJ
Healthcare and Youth Inspectorate Netherlands
Responsible for medical device market surveillance, vigilance system management, clinical trial supervision. Operates as the primary medical device regulatory authority under the Dutch Ministry of Health, implementing EU MDR regulations in the Netherlands.
NVWA
Netherlands Food and Consumer Product Safety Authority
Responsible for safety regulation, market surveillance and enforcement inspections of food, food supplements, and cosmetics. Ensures safety and compliance of consumer products.
RIVM
National Institute for Public Health and the Environment Netherlands
Responsible for public health research, risk assessment, scientific advice and expertise support. Provides scientific basis for regulatory decision-making.
Medical Devices Registration Process
Product Classification Determination
Determine medical device risk classification according to EU MDR 2017/745 (Class I, IIa, IIb, III)
Technical Documentation Preparation
Prepare complete technical documentation including clinical evaluation report, risk management file, performance verification
Notified Body Assessment
Undergo technical documentation review and on-site audit by EU Notified Body
European Authorized Representative
Appoint authorized representative in Netherlands or EU for regulatory communications
EUDAMED Registration
Complete product and economic operator registration in EUDAMED database
Cosmetics Registration
Regulatory Requirements
- CPNP Notification (Cosmetic Products Notification Portal)
- Product Information File (PIF) Dutch Version
- Cosmetic Product Safety Report (CPSR)
- Good Manufacturing Practice (GMP) Certification
- Dutch Product Labeling
- Ingredient Safety Data
- Nanomaterial Notification (if applicable)
- CMR Substances Compliance Proof
- Responsible Person in Netherlands
Main Process
- Safety Assessment Completion
- Product Information File Preparation
- CPNP Notification Submission
- Labeling Compliance Review
- Responsible Person Appointment Completion
Registration Timeline
3-6 months
Official Fees
€0 - €3,000
Service Fees
$6,000 - $16,000
Regulatory System Overview
IGJ
Healthcare and Youth Inspectorate Netherlands
Responsible for medical device market surveillance, vigilance system management, clinical trial supervision. Operates as the primary medical device regulatory authority under the Dutch Ministry of Health, implementing EU MDR regulations in the Netherlands.
NVWA
Netherlands Food and Consumer Product Safety Authority
Responsible for safety regulation, market surveillance and enforcement inspections of food, food supplements, and cosmetics. Ensures safety and compliance of consumer products.
RIVM
National Institute for Public Health and the Environment Netherlands
Responsible for public health research, risk assessment, scientific advice and expertise support. Provides scientific basis for regulatory decision-making.
Cosmetics Registration Process
Safety Assessment
Complete cosmetic product safety report (CPSR) by qualified safety assessor
PIF Documentation Preparation
Prepare complete product information file including Dutch version
CPNP Notification
Submit product information through EU Cosmetic Products Notification Portal
Responsible Person Appointment
Appoint responsible person in Netherlands for product compliance
Labeling Compliance Review
Ensure labeling complies with Netherlands market specific requirements
Food Supplements Registration
Regulatory Requirements
- EU Food Regulation (EC) No 178/2002 Compliance
- Netherlands Food and Consumer Product Safety Regulations Compliance
- Nutrition and Health Claims Compliance (EC) No 1924/2006
- Dutch Product Labeling
- Ingredient Specifications and Purity Proof
- Heavy Metals and Contaminants Testing
- Microbiological Test Reports
- Allergen Information Declaration
- Netherlands Specific Ingredient Restrictions Compliance
Main Process
- Ingredient Compliance Assessment
- Technical Documentation Preparation
- Labeling Review Preparation
- HACCP System Establishment
- NVWA Compliance Preparation
Registration Timeline
3-6 months
Official Fees
€500 - €5,000
Service Fees
$7,000 - $18,000
Regulatory System Overview
IGJ
Healthcare and Youth Inspectorate Netherlands
Responsible for medical device market surveillance, vigilance system management, clinical trial supervision. Operates as the primary medical device regulatory authority under the Dutch Ministry of Health, implementing EU MDR regulations in the Netherlands.
NVWA
Netherlands Food and Consumer Product Safety Authority
Responsible for safety regulation, market surveillance and enforcement inspections of food, food supplements, and cosmetics. Ensures safety and compliance of consumer products.
RIVM
National Institute for Public Health and the Environment Netherlands
Responsible for public health research, risk assessment, scientific advice and expertise support. Provides scientific basis for regulatory decision-making.
Food Supplements Registration Process
Ingredient Compliance Assessment
Verify all ingredients comply with Netherlands and EU permitted lists
Nutrition Claims Review
Review all nutrition and health claims for EU regulation compliance
Labeling Compliance Review
Ensure labeling fully complies with Netherlands labeling regulations
HACCP System
Establish Hazard Analysis and Critical Control Points system
NVWA Compliance
Prepare for inspections by Netherlands Food and Consumer Product Safety Authority