As of the 26th of May 2022, the In-Vitro Diagnostic Medical Device Regulation (IVDR 2017/746) will become applicable in place of the current In-Vitro Diagnostic Directive (IVDD 98/79/EC) for placing on the European market and putting into service In Vitro Diagnostic Medical Devices (IVDs).

The introduction of the Regulation will have major impacts on Manufacturers of IVDs:

  • A classification based on a risk approach (4 classes, A, B, C and D) will replace the list-based approach (2 lists, A and B).
  • More than 80% of IVDs will require conformity assessment by a Notified Body, increasing the need of manufacturers to work with a Notified Body.
  • New requirements are introduced for the demonstration of the clinical evidence (clinical data and performance evaluation results).

Due to the uncertainty related to the application of the Notified Bodies for accreditation under the IVDR and because of the increased volume of IVDs that will require conformity assessment, a lower availability of the Notified Bodies is anticipated. It is therefore essential for Manufacturers to be prepared to face the upcoming changes introduced by the IVDR in order to be able to CE mark products as of the application date.

In order to support Manufacturers complying to the IVDR requirements, Medidee proposes the following services:

  • Review of claims and strategy
  • Classification of IVDs
  • Regulatory pathway development
  • Applicable standards identification
  • Performance evaluation strategy definition
  • Setup of Quality Management System (QMS) and support for ISO 13485:2016 certification