A compliant quality management system is a cornerstone of most global IVD regulatory systems, whether that be the QSRs in the U.S. or ISO 13485 in the EU.  ISO13485 is the harmonized standard. However, the IVD Directive itself clearly states that all devices must have a quality system compliant with the requirements of Annex III of the IVD Directive, so a quality management system is essential to being able to place products on the European market.

A quality management system ensures that good manufacturing practices are established and maintained so that the product which is safe and effective and meets specifications is produced reproducibly.  If a manufacturer requires a notified body to CE mark their product, then the notified body is responsible for auditing to the requirements of the Directive. Companies often choose to gain certification to ISO 13485. But manufacturers may choose not to apply ISO 13485. In this scenario, they will be assessed directly to Annex IV or VII of the IVD Directive. However, they must demonstrate a system with comparable solutions to the requirements in the Directive as described in ISO 13485.

If any manufacturer does not meet the requirements of the standard, a non conformity will be raised. If this is not addressed, it could lead to first the suspension and then withdrawal of a certificate, which means that the manufacturer may no longer be able to support regulatory approval if used to support a regulatory conformity route.

It is important to remember ISO13485 is entitled “Quality Management Systems — Requirements for Regulatory Purposes” and as such is a conformity route for many countries including EU, Canada, and Australia. It is therefore not a marketing tool but it is one of the key requirements needed to gain market access in these countries. A quality system appropriately applied will enable a company to make safe reproducible products, which is why regulators use it as a key tool for entry into their markets.