In Vitro Diagnostic Directive IVDD 98/79/EC & Update IVDR
The In Vitro Diagnostic Medical Devices Directive (IVDD) defines common regulatory requirements dealing specifically with the safety, quality and performance of in vitro diagnostic medical devices (IVDs), thereby bringing them into line with other medical devices. The Directive is intended to ensure that IVDs do not compromise the health and safety of patients, users and third parties and attain the performance levels attributed to them by their manufacturer.
The IVD Directive is applicable to: “devices intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, solely for the purpose of providing information
- concerning a physiological or pathological state
- concerning a congenital abnormality
- to determine safety and compatibility with potential recipients or
- to monitor therapeutic measures.”
In vitro diagnostic devices become more and more important in daily medical routine to make care more efficient. These medical devices are subject to regulatory requirements. The applicable IVD-directive is subject to an update: the current 2012-draft IVDD specifies more robust clinical evaluation requirements prior to bringing the device to market.
The training is set up to give first the basic background info on the Medical Device Directive, i.e. how to bring a medical device to market, and on the specific category of in vitro medical diagnostic devices. In addition, the 1998 and 2012 versions of the IVDD are compared and specific attention is focused on the methodology to perform the ‘clinical evaluation’ of IVD-medical devices via determination of the sensitivity and specificity of the diagnostic test.
Additional ISO-standards are considered in relation to the IVD-medical devices directive. Following elements are addressed:
- Medical devices intended for self-testing (e.g. for blood glucose or pregnancy testing)
- Sampling procedures for acceptance testing – statistical methods
- Performance evaluation of IVD-medical devices
- Metrological traceability of calibrators
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Erkenningsnummer Allanta: DV.O105117
The training outlines the essentials of this Directive:
- The MDD and IVDD
- Explanation of terms and definitions
- Essential requirements
- Relation to risk management
- Conformity assessment procedures: regulatory pathways to market
- 2012 version of the IVDD
- Clinical evaluation : what ?
In addition, essential elements of applicable IVDD-related ISO standards are addressed:
- Clinical evaluation: how ?
- classification of IVD-medical devices – focus on self testing devices
- sampling procedures and performance testing
- the clinical laboratory environment for IVD-device testing
- traceability and validation of quality control tests
- stability of reagents
- labeling requirements
All students who attend 75% of classes, will receive a certificate of participation.