De kwalificatiecriteria betreffen de verschillende functies binnen het conformiteitsbeoordelingsproces, zoals audits, productevaluatie of producttests, evaluatie van de technische documentatie, besluitvorming en vrijgave van partijen, en de hulpmiddelen, technologieën en gebieden, zoals biocompatibiliteit, sterilisatie, zelftesten en near-patient testing, companion diagnostics en prestatie-evaluatie, die onder de aanwijzing vallen.
The qualification criteria shall address the various functions within the conformity assessment process, such as auditing, product evaluation or testing, technical documentation review, decision-making, and batch release, as well as the devices, technologies and areas, such as biocompatibility, sterilisation, self and near patient-testing, companion diagnostics and performance evaluation, covered by the scope of designation.eurlex-diff-2017 eurlex-diff-2017