Medical Device Link.

Originally Published IVD Technology June 2003

IVD DIRECTIVE

I. Facilities

• The working environment must be made safe for staff and study participants.
• Sufficient and appropriate equipment, materials, and reagents must be used.

II. Quality Policy

• Policies, procedures, and laboratory methods must be documented.
• Internal and external quality assurance procedures and systems should be documented and evaluated.
• Quality systems should cover preanalytical, analytical, and postanalytical phases of sample analysis or examination.

III. Study organization and administration

• A well-constructed staffing structure should be established in advance.
• Accountability and job responsibilities for each employee should be clearly designated and documented.

IV. Staff qualifications

• Sufficient numbers of staff should be available to administer the evaluation.
• Staff should have received appropriate education and training, along with provisions for continuing education and an assurance of staff competencies.
• Staff performing testing should have received postsecondary education in appropriate scientific disciplines and training in laboratory procedures.
• Laboratory directors should have graduate degrees in medicine or science, as well as specialized postgraduate education and training in clinical laboratory work.

Copyright ©2003 IVD Technology