TS EN 1041 Information Provided by Medical Device Manufacturers

In the EN 1041 standard, which is a European standard, the characteristics of the information to be provided by companies producing medical equipment are explained. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN 1041 Information provided by medical device manufacturers.

The standard describes the rules for information to be provided by companies producing medical equipment that are subject to directives 90/385 / EEC and 93/42 / EEC on active medical equipment placed in the human body. Based on these directives issued for the European Union countries, the following legal regulations have been issued by the Ministry of Health in our country:

• Active Implantable Medical Devices Directive (90/385 / EEC)
• Medical Device Directive (93/42 / EEC)

The TS EN 1041 standard provides guidance on the method by which certain rules are met and is designed to complement certain rules of the legal regulations for the referenced medical equipment.

A manufacturer must comply with the relevant basic rules for the information to be provided within the scope of the standard. However, this standard does not include the rules for providing information on in-body medical diagnostic equipment contained in other standards on labeling.

Naturally, patients expect the medical equipment used to be safe. The use of these devices should provide efficiency in therapy. That's why it is important to prove equipment compatibility. The information to be provided by the company that manufactures the medical equipment is evidence that this equipment is reliable and performs effectively.

The compatibility of medical equipment and the information provided are important to the success of every medical device manufacturing company. Otherwise, the future of this equipment is endangered. Informing is an important issue in three ways:

• Ensuring the safety of the medical device
• Getting medical device approval from regulatory bodies
• Medical device testingmake sure they are smooth

Within the scope of laboratory services, our organization also provides services to enterprises on information provided by companies that produce EN 1041 medical equipment.