IVD Industry

In recent years, the In Vitro Diagnostic (IVD) Industry has rapidly evolved to support different applications such as the screening, diagnosis and monitoring of chronic and infectious diseases. A large panel of diagnostic technologies is currently available on the IVD market. It ranges from simple lateral flow assays (LFA) intended for self-testing to complex solutions integrating active devices used by central laboratories. IVD products also include reagents, accessories intended for use with IVD devices as well as software.

As many devices in the IVD field are intended to be used by lay persons (self-testing), the user-interaction with the device plays a central role in the safety for the patient. Moreover, an increasing number of IVD tests are coupled with a software application for data analysis and patient interaction. Consequently, a new risk classification system has been introduced by the In Vitro Diagnostic Regulation (IVDR) taking into account individual and public health risks. Currently, a large portion of IVD tests are self-certified in the European market but will undergo conformity assessment with the new Regulation. It will increase the number of IVD manufacturers that will require a Notified Body for both current and new products. It is therefore highly recommended to address IVDR requirements early in the development phase of new products and as soon as possible for actual devices that are foreseen to be affected by a change of classification.

Organizing the work

In order to help you integrate these requirements in the Technical Documentation, Medidee supports you with:

  • the proper classification of your IVD according to IVDD 98/79 and IVDR 2017/746
  • the planning of performance testing
  • if applicable, the preparation of electrical safety and electromagnetic compatibility testing documentation of active devices with respect to the EN 61010 and EN 61326.
  • the development of the software documentation to ensure compliance with the requirements of the IEC 62304.
  • the application of usability engineering according to EN 62366

We specialize in the transition from an existing product from IVDD to IVDR. Please see this specific page.