What will happen to products where the European Union (EU) class is different to the ANZTPA class?
Manufacturers will need to classify the products according to the ANZTPA classification rules and ensure that the appropriate conformity assessment is performed. Top of page What conformity assessment procedures will IVD manufacturers need to follow? All IVDs must undergo a conformity assessment procedure to ensure compliance with the Essential Principles. The minimal level of rigor of this assessment ie the assessment pathway chosen, is determined by the class of the IVD which depends on level and nature of risk posed by the IVD to the patient or user. This ranges from Class 1 IVDs where the manufacturer self certifies, through to a full review of the quality management system and product design dossier review by the regulator for Class 4 IVDs. The common aspects in most conformity assessment procedures are: • quality management system certification; • quality management system surveillance audits; and • a post market monitoring system. The following two conformity assessment procedur
