The European medical device regulations underwent a significant change with the introduction of the EU IVDR 2017/746 in 2017. The regulation covers multiple new requirements affecting many different areas, beginning with the classification of IVD devices to the performance evaluation, post market surveillance and related plans, and vigilance activities.
Throughout the regulation, there is an emphasis on manufacturers having an effective QMS in place and these QMS requirements are clearly defined. The regulation has not specified what standard should be used as a QMS. However, the most accepted and commonly followed QMS by the medical device industry is either ISO 13485:2016, or its harmonized version EN ISO 13485:2016. Although this standard is currently harmonized to the IVD Directive, its harmonization to the IVDR is anticipated in the future.
Companies have adopted ISO 13485 for many years, and therefore their QMS can be said to have matured. However, it is important to note that conformity to ISO 13485 does not mean that manufacturers are fully compliant to the EU IVDR QMS requirements. Given the changes brought in by the regulation, the manufacturers will have to now integrate these new requirements into their QMS. Subsequently, their staff will also have to be trained according to the changes in QMS. Once integrated, the new requirements will have to be a part of the internal audit system and thus, coming under QMS control.
This article details out some of these new requirements.
The obligations of the manufacturer detailed in Article 10(8), states that –
“Manufacturers of devices, other than devices for performance study, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.”
Furthermore, Article 10 clearly helps us understand what changes need to be incorporated in the QMS.
The IVDR expects manufacturers’ QMS to cover and govern the structure, responsibilities, all of its processes, procedures, and resources, thereby achieving compliance with the regulation.