Safety of medical devices

Medical devices are used for medical purposes, such as diagnosis, treatment, prevention, or as support for illness or disability. The range of medical devices is very varied.

This product group consists of relatively simple tools such as surgical tape, hearing aids, glasses and contact lenses, but also more technically complex appliances such as adapted computers, X-ray equipment and surgical instruments. Implants, instruments and screening and diagnosis appliances also fall under the regulations for medical devices.

According to the legal definition, a medical device is: ‘any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used by human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease;
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury
• or handicap;
• investigation, replacement or modification of the anatomy or of a physiological process;
• control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means’.

Laws and regulations

Competent public authorities

Producers' obligations

Notification requirement

Laws and regulations

The safety of medical devices is, among others, based on the law of 9 February 1994 on the safety of products and services .

Regulations on different types of medical devices have been included in the following Royal Decrees:

• Royal Decree of 18 March 1999 concerning medical devices;
• Royal Decree of 14 November 2001 concerning in vitro diagnostic medical devices; 
• Royal Decree of 15 July 1997 concerning active implantable medical devices.

Competent public services

Medical devices other than active implantable medical devices and in vitro diagnostic medical devices

Responsibility for the market surveillance of the medical devices that fall under the Royal Decree of 18 March 1999 on medical devices is divided between:

• the Federal Agency for Medicines and Health Products (FAMHP) ,
• the FPS Economy, SMEs, Self-employed and Energy,
• the Federal agency for Nuclear Control (FANC) .

This division of responsibilities is set out in Annex XIII of the Royal Decree of 18 March 1999 concerning medical devices.

In vitro diagnostic medical devices

Responsibility for the market surveillance of in vitro diagnostic medical devices is divided between:   

• the Scientific Institute of Public Health (IPH) ,
• the FPS Economy, SMEs, Self-employed and Energy, 
• the Federal Agency for Nuclear Control (FANC) .

The department of clinical biology at the Scientific Institute of Public Health (IPH) coordinates these inspection responsibilities.

• This division of responsibilities is set out in Annex XIII of the Royal Decree of 14 November 2001 concerning in vitro diagnostic medical devices.

Active implantable medical devices 

The Federal Agency for Medicines and Health Products is responsible for active implantable medical devices.

Producers’ obligations

Medical devices must be designed and manufactured so that their use does not compromise patient safety nor that of the users when used in the intended conditions and purposes.

Medical devices other than active implantable medical devices and in vitro diagnostic medical devices

These medical devices are classified into four classes (class I, IIa, IIb and III), according to the risk associated with their use. Class I is low risk, classes IIa and IIb are medium risk and class III is high risk.

The classification rules are described in Annex IX to the Royal Decree of 18 March 1999  concerning medical devices.

You will find more explanations and examples in the guide to the classification of medical devices .

With the exception of custom-made devices and medical devices designed for clinical research, all medical devices that meet the essential requirements must carry CE marking.

The intervention of a Notified Body may be required for the approval of the product, depending on the category the medical device has been assigned.

To affix CE marking on a calss IIa, IIb or III medical device and place it on the market, the manufacturer must apply to a Notified Body.
You will find detailed information on the application procedures for assessing conformity in the Royal Decree of 18 March 1999 on medical devices.

Class I medical devices or custom-made devices that are not designed for clinical research must be notified to the medical devices department of the Federal Agency for Medicines and Health Products , no later than the day they are placed on the market.

Notification requirement

Serious incidents and accidents must be reported immediately to the Federal Agency for Medicines and Health Products.

Incidents must be reported not only by the manufacturers or their agents, but also by the persons selling the devices, the Notified Bodies, doctors and persons responsible for receiving and/or delivering the devices.

An incident is:

• any malfunction or deterioration in the features and/or performance
• of a device as well as any discrepancy in the labelling or instructions
• that may lead to or have resulted in the death or serious deterioration in the health
• of a patient or user;  
• any technical or medical reason related to the features and/or performance of a device for the above reasons, and having resulted in
• systematic market recall by the manufacturer of devices of the same type or the systematic repair thereof.

Serious incidents that actually occurred must be reported, in addition to incidents involving a preventable risk of serious incident.

You can find more information on the website of the Federal Agency for Medicines and Health Products and in the European Commission ‘Vigilance Guide’.