Definitions and Classifications of Medical Devices in Belgium

1. Overview

The Federal Agency for Medicines and Health Products (FAMHP) in Belgium provides definitions and classifications for medical devices, in vitro diagnostic medical devices (IVDs), custom-made devices, and accessories, aligned with EU regulations such as the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). These ensure safety, performance, and proper market placement. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/devices_definitions

2. Definition of Medical Device

A medical device is any instrument, apparatus, appliance, implant, reagent, material, or other article, including software or applications, intended for medical purposes. It is used alone or in combination for:

• Diagnosis, prevention, monitoring, prediction, treatment, or alleviation of disease (e.g., blood pressure monitors, ultrasound scanners).
• Diagnosis, treatment, alleviation, or compensation for injuries or disabilities (e.g., bandages, hearing aids, crutches, wheelchairs).
• Investigation, examination, replacement, or modification of anatomy or physiological/pathological processes (e.g., hip or knee implants, leg prostheses, breast implants).
• Control or support of conception (e.g., condoms).
• Cleaning, disinfection, or sterilization of other devices.

Medical devices do not achieve their principal action through pharmacological, immunological, or metabolic means, distinguishing them from medicinal products. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/devices_definitions

3. Definition of In Vitro Diagnostic Medical Device (IVD)

An IVD is used in vitro on human body samples (e.g., blood, tissue) to provide medical information. It includes reagents, control materials, kits, instruments, apparatus, equipment, software, systems, or containers, used alone or in combination, for:

• Assessing physiological states (e.g., pregnancy tests, ovulation tests).
• Detecting or predisposing to medical conditions/diseases (e.g., HIV screening tests).
• Identifying congenital anomalies (e.g., trisomy 21 risk assessment tests, non-invasive prenatal tests).
• Determining donor-recipient compatibility (e.g., blood group determination).
• Defining or monitoring therapeutic measures (e.g., drug concentration monitoring).
• Predicting responses to medicinal products (e.g., companion diagnostics for safety and efficacy).

Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/devices_definitions

4. Custom-Made Devices

Custom-made devices are specifically made for a particular patient's needs based on a written prescription with unique design characteristics (e.g., dental prostheses, orthopaedic shoes or insoles). They are regulated under the same framework but with tailored requirements. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/devices_definitions

5. Accessories

Accessories are items not qualifying as medical devices or IVDs but intended to enable or assist their use. They fall under device regulations (e.g., ultrasound gels, lubricants for gloves, endoscopes, or condoms). Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/devices_definitions

6. Devices for Non-Medical Use

These have similar operation and risk profiles to medical devices but lack a medical purpose. Listed in Annex XVI of Regulation (EU) 2017/745, they include:

• Fashion contact lenses (e.g., color lenses).
• Aesthetic implants (e.g., breast implants).
• Filling substances (e.g., hyaluronic acid).
• Devices for liposuction, lipolysis, or lipoplasty.
• High-intensity electromagnetic radiation devices for skin treatments (e.g., lasers for tattoo or hair removal).
• Brain stimulation devices using electrical currents or electromagnetic fields.

Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/devices_definitions

7. Classification of Medical Devices

Medical devices are classified into four risk-based classes:

• Class I (lowest risk): Prescription glasses, vehicles for disabled persons, crutches, compresses, compression bandages.
• Class IIa (medium/moderate potential risk): Contact lenses, ultrasound equipment, dental crowns, skin staples, hearing aids, ultrasound machines.
• Class IIb (high/high potential risk): Condoms, lens disinfectants, infusion pumps.
• Class III (highest risk): Breast implants, stents, hip prostheses, pacemakers.

Classification is based on hazardousness and intended use per EU regulations. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/devices_definitions

8. Classification of IVDs

IVDs are classified into four classes:

• Class A (low individual and public health risk): General laboratory products (e.g., cleaning solutions, dyes).
• Class B (moderate individual/low public health risk): Pregnancy screening, cholesterol determination.
• Class C (high individual/moderate public health risk): Detection of sexually transmitted agents (e.g., Chlamydia, Herpes, HPV), cancer tests, most self-tests.
• Class D (high individual and public health risk): Tests for HIV, SARS-CoV-2, hepatitis C, blood group markers (ABO).

Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/devices_definitions

9. Regulatory Notes

Definitions align with EU MDR and IVDR. Borderline products are those with similar risks but non-medical purposes, regulated accordingly. Last updated: 24/07/2024. Source: https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/generalities/devices_definitions