European Union Product Registration & Certification
Important Notes
- Regulatory Applicability: Medical devices under MDR/IVDR, cosmetics under EC 1223/2009, classify by risk and select conformity route.
- EU Authorized Representative: Mandatory for non-EU manufacturers to appoint a representative within the EU.
- CE Marking Process: Undergo notified body audit (Class IIa+), complete technical documentation, and affix CE mark.
- EUDAMED Database: Assign UDI and register product/economic operator information in EUDAMED.
- Post-Market Obligations: Establish vigilance system and post-market surveillance plan for ongoing safety monitoring.
- Harmonization Principle: Follow EU harmonized framework while meeting member state implementation requirements like labeling.
European Union specific Requirements
- Single Market System: CE mark demonstrates compliance with EU essential requirements for free circulation.
- Full Lifecycle Management: Regulations mandate continuous oversight and evidence updates from design to withdrawal.
- Notified Body Resources: Certification depends on limited notified bodies, affecting time-to-market.
- Digital Supervision Platform: EUDAMED enables regulatory transparency and coordinated oversight.
- Strategic Alignment: Regulatory evolution aligns with EU Green Deal and Digital Health Strategy directions.
Medical Devices Registration
Regulatory Requirements
- CE Marking Certification (according to MDR 2017/745)
- Classification Management per MDR (Class I, IIa, IIb, III)
- Complete Technical Documentation
- 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
- Declaration of Conformity (DoC)
- EUDAMED Database Registration
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Notified Body Assessment
- Conformity Assessment Completion
- EUDAMED Registration
- CE Certificate Acquisition
Registration Timeline
12-30 months
Official Fees
€8,000 - €150,000
Service Fees
$25,000 - $80,000
Regulatory System Overview
European Commission
European Commission
Responsible for developing unified EU regulations including Medical Device Regulation (MDR), Cosmetic Regulation, Food Regulation. Coordinates EU internal market operations and ensures product safety and regulatory consistency.
Notified Bodies
Notified Bodies
Independent third-party organizations designated by EU member states, responsible for conformity assessment of medical devices and issuing CE certificates under MDR regulation.
Member State CA
Member State Competent Authorities
National regulatory authorities designated by each member state, responsible for medical device market surveillance, vigilance system management, and regulation enforcement for cosmetics and food supplements.
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 (Class IIa and above)
European Authorized Representative
Appoint authorized representative in 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)
- Cosmetic Product Safety Report (CPSR)
- Good Manufacturing Practice (GMP) Certification
- Responsible Person in EU
- Ingredient Safety Data
- Nanomaterial Notification (if applicable)
- CMR Substances Compliance Proof
- Labeling Compliance
Main Process
- Safety Assessment Completion
- Product Information File Preparation
- CPNP Notification Submission
- Responsible Person Appointment Completion
- Post-Market Monitoring Establishment
Registration Timeline
3-6 months
Official Fees
€0 - €5,000
Service Fees
$6,000 - $18,000
Regulatory System Overview
European Commission
European Commission
Responsible for developing unified EU regulations including Medical Device Regulation (MDR), Cosmetic Regulation, Food Regulation. Coordinates EU internal market operations and ensures product safety and regulatory consistency.
Notified Bodies
Notified Bodies
Independent third-party organizations designated by EU member states, responsible for conformity assessment of medical devices and issuing CE certificates under MDR regulation.
Member State CA
Member State Competent Authorities
National regulatory authorities designated by each member state, responsible for medical device market surveillance, vigilance system management, and regulation enforcement for cosmetics and food supplements.
Cosmetics Registration Process
Safety Assessment
Complete cosmetic product safety report (CPSR) by qualified safety assessor
PIF Documentation Preparation
Prepare complete product information file including all technical data
CPNP Notification
Submit product information through EU Cosmetic Products Notification Portal
Responsible Person Appointment
Appoint responsible person in EU for product compliance
Post-Market Monitoring
Establish serious adverse reaction reporting and monitoring system
Food Supplements Registration
Regulatory Requirements
- EU Food Regulation (EC) No 178/2002 Compliance
- Nutrition and Health Claims Compliance (EC) No 1924/2006
- Member State National Notification Requirements
- Ingredient Compliance Assessment
- Good Manufacturing Practice (GMP)
- Labeling and Advertising Compliance
- Allergen Information Declaration
- Member State Specific Requirements Compliance
Main Process
- Target Market Determination
- Ingredient Compliance Assessment
- Technical Documentation Preparation
- National Notification Submission
- Post-Market Compliance Monitoring
Registration Timeline
4-9 months
Official Fees
€1,000 - €10,000
Service Fees
$8,000 - $22,000
Regulatory System Overview
European Commission
European Commission
Responsible for developing unified EU regulations including Medical Device Regulation (MDR), Cosmetic Regulation, Food Regulation. Coordinates EU internal market operations and ensures product safety and regulatory consistency.
Notified Bodies
Notified Bodies
Independent third-party organizations designated by EU member states, responsible for conformity assessment of medical devices and issuing CE certificates under MDR regulation.
Member State CA
Member State Competent Authorities
National regulatory authorities designated by each member state, responsible for medical device market surveillance, vigilance system management, and regulation enforcement for cosmetics and food supplements.
Food Supplements Registration Process
Target Market Determination
Identify target member states for primary sales and their specific requirements
Ingredient Compliance Assessment
Verify ingredients comply with permitted lists in target countries
Nutrition Claims Review
Review all nutrition and health claims for EU regulation compliance
National Notification Submission
Submit notifications to competent authorities of target member states (if applicable)
Labeling Compliance Review
Ensure labeling complies with EU and member state specific requirements