Ivd

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.

The key success criterion is the ability of the Medidee support team to capture the detailed design, regulatory and quality aspects specific to the product.

Medidee integrates a full experienced scientific/regulatory/quality team ready to provide strategic consulting services to:

• Large enterprises that may need an expert opinion on a very specific topic
• Small and Medium-Sized Businesses that may need support with specific scientific/regulatory/quality activities
• Start-ups that may need support to plan on the long run their development activities (including setup of proper V&V activities and preparation of technical documentation), to implement a quality management system, to implement management of manufacturing activities (including supplier control) and to assist during contacts with Notified Bodies and Competent Authorities