CE Marking for Medical Devices in Belgium

1. Overview

The Federal Agency for Medicines and Health Products (FAMHP) in Belgium manages CE marking for medical devices and in vitro diagnostic devices (IVDs), ensuring they meet essential requirements for performance, safety, and benefits under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Source: https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/generalities/ce_marking

2. Definitions

• The CE marking certifies compliance with applicable legislation, verifying the device's performance, safety, and intended benefits.
• Notified body: A private organization designated by competent authorities (in Belgium, by FAMHP) to conduct conformity assessments, ensuring independence, expertise, and resources. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/generalities/ce_marking

3. Requirements

• The CE marking must be visible, legible, and indelible on the device (if technically feasible), instructions for use, and sales packaging.
• It applies to devices marketed in the European Economic Area (EEA) and countries with collaboration agreements. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/generalities/ce_marking

4. Conformity Assessment Procedures by Class

Class I Medical Devices and Class A IVDs (Lowest Risk)

• Self-certification by the manufacturer; no notified body required. CE marking without a four-digit notified body code.
• Exceptions: Class I sterile, measuring function, or reusable surgical instruments; Class A sterile IVDs. Notified body assesses sterile conditions, metrological conformity, or reuse aspects (cleaning, disinfection, sterilization, maintenance, functional testing, instructions). Source: https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/generalities/ce_marking

Higher Risk Classes

• Most devices and IVDs require CE marking approved by a notified body.
• For Class III custom-made implantable devices, notified body approval is mandatory, even without CE marking. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/generalities/ce_marking

Systems and Procedure Packs

• Self-certification by the assembler; CE marking required if including non-CE marked devices, incompatible combinations, or improper sterilization. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/generalities/ce_marking

5. Roles of Notified Bodies

• Conduct conformity assessments for CE marking approval.
• Assess specific aspects for exceptions (e.g., sterile conditions, metrological conformity, reuse).
• Identified by a four-digit code following the CE marking; list available at the EU Commission's NANDO database. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/generalities/ce_marking

6. Manufacturer Responsibilities

• Ensure quality, safety, and efficacy for self-certified devices (e.g., Class I and Class A).
• Affix CE marking after notified body certification or self-certification.
• For custom-made devices: Self-certification, except Class III implantable (notified body required).
• Demonstrate no therapeutic alternatives for exceptional market placement without CE marking (per Article 59 of MDR or Article 54 of IVDR). Source: https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/generalities/ce_marking

7. Declaration of Conformity

• Issued by the manufacturer through self-certification for applicable devices. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/generalities/ce_marking

8. Technical Documentation

• Required to support conformity assessments, though not explicitly detailed in the overview. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/generalities/ce_marking

9. Post-Market Surveillance

• Manufacturers must implement systems to monitor device performance post-market, though specifics are not detailed here. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/generalities/ce_marking

10. Transitional Provisions or Updates

• Devices without CE marking include custom-made devices (self-certification except Class III implantable), systems/procedure packs (self-certification by assembler), and devices for clinical/performance studies.
• Exceptional placement without CE marking allowed by the minister of public health or delegate under specific conditions (e.g., no therapeutic alternatives).
• Last updated: 01/12/2023. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/generalities/ce_marking

11. MDR and IVDR Specifics

• Medical devices under Regulation 2017/745 (MDR): Classes I, IIa, IIb, III.
• IVDs under Regulation 2017/746 (IVDR): Classes A, B, C, D.
• IVDR specifics: Class A IVDs self-certified, with exceptions for sterile requiring notified body checks. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/generalities/ce_marking