CE Marking is a mandatory requirement for medical devices entering the EU market, which ensuring compliance with relevant safety, effectiveness, and quality standards. The certification process is primarily based on the Medical Device Regulation (MDR 2017/745) or the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746).

F&D Group offers comprehensive MDR & IVDR services, including:

1. Testing Service:

(1) Biocompatibility Testing (ISO 10993)

·       Cytotoxicity

·       Skin Irritation

·       Intracutaneous Reaction

·       Acute Systemic Toxicity

·       Skin Sensitization

·       Pyrogenicity

·       Hemocompatibility

·       Degradation and Biodistribution Studies for Long-Term Implants

(2) Electrical Safety and Electromagnetic Compatibility (EMC) Testing

·       Electrical Safety (IEC 60601-1) (Applicable to active medical devices)

·       Electromagnetic Compatibility (IEC 60601-1-2) (Testing for electromagnetic emissions, immunity, etc.)

·       Medical Device Software (IEC 62304) (Software lifecycle requirements for medical devices)

·       Cybersecurity Testing (ISO 27001) (Applicable to connected medical devices)

(3) Mechanical Performance and Physical Testing

·       Mechanical Durability Testing (Strength and fatigue testing for catheters, stents, implants, etc.)

·       Fluid Dynamics Testing (Applicable to intravascular devices)

·       Packaging Integrity Testing (ISO 11607) (Sterile barrier system testing for medical devices)

(4) Sterilization Validation Testing (ISO 11135 / ISO 17665)

·       Ethylene Oxide (EtO) Sterilization

·       Moist Heat Sterilization (Steam Sterilization)

·       Radiation Sterilization (Gamma/Electron Beam)

·       Sterility Testing (ISO 11737)

(5) In Vitro Diagnostic (IVD) Testing (ISO 15189, CLSI Standards)

·       Accuracy and Repeatability Testing

·       Sensitivity and Specificity Validation

·       Cross-Reactivity Testing

2. Consulting Services

(1) Regulatory and Compliance Strategy Consulting

·       Product Classification Determination (Class I, IIa, IIb, III medical devices or Class A, B, C, D IVD products)

·       Conformity Assessment Route Selection (Self-declaration, Notified Body review, clinical trial requirements, etc.)

·       MDR/IVDR Compliance Pre-Assessment (Preliminary review of product compliance with the latest regulations)

(2) Technical Documentation Support

·       Preparation of Technical Documentation (In compliance with MDR Annex II requirements)

·       Clinical Evaluation Report (CER) Compilation

·       Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) Strategies

·       Risk Management Documentation (ISO 14971) Preparation and Optimization

·       Product Labeling and Instructions for Use (IFU) Compliance Review

·       Pre-Audit for Notified Body Certification

(3) EU Representative (EC Representative) and Registration Services

·       EU Authorized Representative Services (Legal representation for non-EU manufacturers)

·       EUDAMED Database Registration and Unique Device Identification (UDI) Compliance

(4) Clinical Trials and Biostatistical Analysis

·       Clinical Trial Design and Data Analysis

·       Ethics Committee Approval Support

(5) Market Access and Compliance Change Support

·       Product Recall and Adverse Event (Vigilance) Management

·       Change Management Support (Product upgrades, manufacturing changes, registration updates)

3. Training Services

(1) Regulatory and Certification Process Training

·       MDR/IVDR Regulatory Interpretation (Regulatory requirements, product classification, certification pathways)

·       Medical Device CE Certification Process and Conformity Assessment Routes

·       Market Access Requirements for Medical Devices

(2) Technical Documentation and Clinical Evaluation Training

·       Preparation and Review of Technical Documentation (How to prepare MDR-compliant technical files)

·       Clinical Evaluation Report (CER) Writing Training (Based on MDCG guidelines)

·       Post-Market Surveillance (PMS) Training (How to establish a PMS/PMCF system)

(3) Quality Management and Risk Management Training: Internal Auditor Training

(4) Product Testing and Compliance Standards Training

·       Biocompatibility Testing (ISO 10993) Training

·       Electromagnetic Compatibility (EMC) and Electrical Safety Testing Training (IEC 60601-1/-2 interpretation)

·       Sterilization Validation (ISO 11135/ISO 17665) Training

(5) EUDAMED and UDI Registration Training

·       Usage and Registration Process for EUDAMED Database

·       UDI (Unique Device Identification) System Compliance Requirements