Test and Analysis of Medical Device Directive 93/42/EEC

The legal regulation 93/42/EEC published in the European Union countries has a very wide scope and its purpose is to ensure the free movement of safe medical devices within the European Union countries. Within the framework of this legal regulation, all devices must be safe for patients, users and third parties and must reach the maximum performance level attributed by the manufacturers.

The said legal regulation covers medical devices used for diagnosis, monitoring and treatment of individuals. This directive was replaced by the later directive 2017/745 (EU).

The countries of the European Union must take all necessary steps to ensure that devices are placed on the market and put into service only if they comply with the requirements set out in this directive, if they have been duly supplied and properly installed, maintained and used in accordance with their intended use.

Medical devices are classified according to this regulation:

• Class I: Low-risk devices
• Class IIa: Medium risk devices
• Class IIb: Medium risk devices
• Class III: High-risk devices

Before a manufacturer begins the procedure necessary to evaluate its product, it must decide whether the product in question should be self-assessed or whether a notified body should be involved.

Medical devices grouped as Class I (low risk devices) can be evaluated and declared by the manufacturers in terms of safety and compliance with the medical devices directive. However, for medical devices falling under class IIa, IIb and III (medium and high risk devices), manufacturers are required to involve notified bodies to carry out the necessary conformity assessment procedures. Notified bodies shall determine and declare the conformity of the product with the requirements of this directive. In other words, the notified body must participate in the evaluation of such medical devices.

Briefly, this directive covers any medical device that performs the following functions:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease
• Diagnosing, monitoring, treating, mitigating or compensating for an injury or disability
• Investigation, modification or modification of anatomy or a physiological process
• pregnancy control

Among the numerous tests, measurements, analyses, and evaluations our organization provides for businesses in various sectors, we also offer testing and analysis services under the Medical Devices Directive 93/ 42 /EEC, utilizing a trained and expert staff and advanced technological equipment.