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

The difficult exercise of preparing a Clinical Evaluation Report (CER) usually starts in three different contexts:

  • Before a Clinical Investigation, in order to precisely evaluate the currently available clinical assets such as literature with the objective to correctly scope the investigation
  • After a Clinical Investigation, in order to build the appropriate evidence of fulfillment of the essential requirement related to clinical safety and efficacy, as part of a regulatory submission such as CE marking.
  • After a regulatory submission when the Notified Body or the FDA indicates that either the methodologic adherence to MEDDEV 2.7/1 Rev. 4 is not demonstrated or if part of the core data set is deemed insufficient.

The support of Medidee may include full work packages with the delivery of a turnkey CER or may focus on a specific strategic coaching, or a review.

Medidee integrates a full scientific team ready to write your CER, including the difficult organization of literature search.

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