Medical Device Link.

Originally Published IVD Technology June 2003

IVD DIRECTIVE

The European standard for Performance Evaluation of In Vitro Diagnostic Medical Devices (EN 13612) was adopted by the European Committee for Standardization (CEN) in 2002.⁹ Although compliance with the standard is voluntary, it offers a useful starting point for manufacturers that are designing performance studies to demonstrate that a product meets the requirements of the IVD Directive. Key elements of this guidance are as follows.

• Candidate IVDs should be subject to all conditions for use that can be reasonably anticipated.
• Special attention must be paid to the conditions of use for IVDs designed for use by laypersons (e.g., point-of-care tests).
• Manufacturers should specify which specimen types are appropriate for use with the candidate IVD.
• Testing procedures should be clearly defined.
• The candidate IVD should be subjected to all possible common interfering factors caused by the conditions of the specimen, the pathological or physiological state of the specimen donor, or by any medical treatment the donor may have been under at the time of donation.
• When evaluating quantitative IVDs, investigators must employ an appropriate reference measurement procedure (e.g., an alternative test procedure). A reference material should be used, when available.
• When evaluating qualitative IVDs, a procedure must be used to determine the status of the specimens.
• Calibration procedures, including traceability, must be employed and documented at all applicable stages of the evaluation.
• Investigators must follow appropriate control procedures (e.g., external proficiency testing).
• Limitations of the evaluation procedure must be thoroughly described and documented.
• Suitability and stability of specimens should be confirmed.
• Specimen exclusion criteria should be documented.
• Handling procedures should be documented, when necessary.

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