LNE/G-MED IVD-Specific Services

Manufacturers continue to develop and release faster and more accurate in vitro diagnostic devices (IVD devices).  While the industry has faced consolidation and recent economic difficulties, the aging population, demand for healthcare, and emerging markets point to a healthy prognosis for the future of IVD devices and public health.

Entrusting your IVD device with LNE/G-MED's IVD-specific Project Managers means your device receives specialized evaluation and can get to the market efficiently and effectively.

What Is An IVD Device?

IVD devices analyze human body fluids to provide critical diagnostic information that helps to prevent and treat diseases.  According to the IVDD, the IVD device provides information:

• About a physiological or pathological state; or
• About a congenital abnormality; or
• Determining the safety and compatibility with potential recipients; or
• Monitoring therapeutic measures.

CE Marking an IVD Device

To affix the CE Marking for an IVD Device, an IVD manufacturer must follow the requirements for conformity assessment in the IVDD.  For some IVD devices, a Notified Body must assess the device design file and the quality management system to ensure the device conforms to the Essential Requirements in the IVDD.

LNE/G-MED IVD CE Mark

With LNE/G-MED, IVD manufacturers receive personal attention from their project manager, an IVD expert.   LNE/G-MED is notified since the IVD directive was first published, with a full scope of tasks which includes all IVD listed in Annex II List A and List B as well as self-tests. LNE/G-MED has successfully delivered IVD CE marking services for more than 10 years.

Your IVD device's Project Manager has access to all of LNE/G-MED's services, including combined certification that allows your IVD to be certified to more than one market in one audit.  Contact Us today to learn how LNE/G-MED can help get your IVD Device on the market.