EUROLAB, with its state-of-the-art accredited laboratories and expert team, offers precise and rapid testing services within the scope of EN ISO 18113-3 testing. EN ISO 18113-3 specifies requirements for information provided by the manufacturer of in vitro diagnostic (IVD) devices for professional use. EN ISO 18113-3 also applies to apparatus and equipment intended for use with IVD devices for professional use.
The International Medical Device Regulators Forum (IMDRF) promotes the convergence of the development of regulatory systems for medical devices at a global level. Eliminating regulatory differences between jurisdictions could allow patients to access new technologies and treatments sooner. This standard provides a basis for harmonizing labeling requirements for IVD devices for professional use.
This standard relates only to information provided with IVD devices and equipment for professional use. It is intended for use in conjunction with EN ISO 18113-1, which contains general requirements for information provided by the manufacturer and definitions of general labeling concepts.
When including any statement on the label regarding the manufacturer's liability in the event of damage or injury resulting from any use or malfunction of the device, the laws or regulations in the area of use should be taken into account.
Labeling shall not contain any disclaimers regarding the safety and performance of the device for its intended use that are inconsistent with the manufacturer's obligations to design and manufacture a product that is safe and performs as intended throughout its expected life. Laws and regulations governing use must be taken into account.
EUROLAB assists manufacturers with EN ISO 18113-3 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
