Key aspects specific to the in-vitro Diagnostics Regulation (IVDR)

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The Regulation on in-vitro diagnostic medical devices (IVD) has many common aspects and requirements to the Regulation on medical devices but system changes and other IVD specific changes will have important implications and changes for that product sector. These include, but are not limited to:

  • Classification system – the IVDR introduces a rules-based classification system for IVDs. IVDs will now be classified into four different classes based on risk from class A (low) to class D (high). This will mean that regulation and assessment for each class of device can be tailored accordingly.

 

  • Changes to conformity assessment procedures – IVDs will now be subject to conformity assessment based on the classification of the device. Classes B, C and D IVDs will all require assessment and certification by a notified body for medical devices (appropriately designated for IVDs) prior to being placed on the market. This represents a significant change in the system today where many IVDs are self-declared devices rather than being assessed by a notified body.

 

  • Performance evaluation and clinical data requirements – the requirements for performance evaluation of IVDs are defined in much greater detail in the new Regulations. Specific requirements are also defined in relation to the use of clinical data for IVDs and the conduct of clinical performance studies.

 

  • Changes to requirements for in house manufacturing of IVDs – under the existing legislation IVDs which are manufactured within a healthcare institution and for use within that health institution are exempted from the Directive. Such tests may be developed due to the lack of a commercially available alternative e.g. for rare diseases. The new Regulation places requirements on ‘in-house’ IVDs and the healthcare institutions which manufacture them and allows the introduction of additional requirements at national level by individual member states.