In-Vitro Diagnostic Directive 98/79/EC (IVDD)

Intertek has the expertise to help you navigate the IVDD quickly, cost effectively, and successfully. With three Notified Bodies in Europe, Intertek has helped countless in-vitro diagnostic device manufacturers gain market access into the European Union.

The In-Vitro Diagnostic Directive (IVDD) 98/79/EC addresses the essential requirements that an in-vitro diagnostic device must meet before being marketed within the European Union. The requirements called out within the IVDD are essentially a grouping of requirements covered within the Active Implantable Medical Devices Directive and Medical Devices Directive (MDD) 93/42/EC.

The scope of the IVDD covers all in-vitro diagnostic devices and their accessories. An in-vitro device is defined as any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system to be used in-vitro for the examination of blood or tissue specimens.

In comparison to the MDD, the IVDD places greater emphasis on the potential risk involved during the use of the product. With that, the intended use and the potential risks must be outlined in a risk assessment. In addition, the IVDD calls out specific design, manufacturing, packaging, and labeling requirements.

Meeting the IVDD standards is easy by following these simple steps:

1. Determine your product group based on its function

• Self-testing devices; such as those products deemed for home use
• Reagents and reagent products, including calibrators and control materials for determining blood groups or the detection and confirmation of HIV or Hepatitis infection - Annex II, List A Device
• Reagents for blood typing and self-diagnosis devices - Annex II, List B Device
• Products that do not fall into the first three groups

2. Determine the essential requirements based on your product group

3. Fulfill the essential requirements – Depending on your product group, you will need to provide/complete a combination of the following essential requirements:

• Provide technical documentation (technical file) containing full construction details of your in-vitro diagnostic device.
• Show compliance to the essential requirements and/or applicable harmonized standards.
• Provide a risk assessment, including construction evaluation, materials used, bio-compatibility analysis, infection, and cross-infection risks.
• Meet the quality system requirements of the Directive.

4. Establish a monitoring system - As a manufacturer, you are required to monitor your products once they are on the market in case necessary updates must be made according to updated requirements of the IVDD.

5. Establish an incident reporting system - If an incident or near-incident involving any of your products takes place, you are obliged to report this to your local governing body for medical devices.

6. Prepare a Declaration of Conformity / Apply CE Marking

7. Register with the local governing body for medical devices

 

Contact us to see how Intertek can help your organization with In-Vitro Diagnostic Directive 98/79/EC (IVDD).