title: The IVD directive.
authors.forename: J
authors.initials: J
authors.lastname: Dhell
mesh_terms: D019985:Benchmarking; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D005062:European Union; D006801:Humans; D008828:Microbiological Techniques / Q000592:standards*; D011356:Product Labeling