The MD Regulation is entering into force – is your quality management system in order?
If your company works in the field of medical devices, it is important for you to know that the new Medical Devices Regulation (MDR, EU 2017/745) requires all manufacturers of medical devices to have a quality management system.
The MDR sets out requirements for various economic operators, especially device manufacturers. Among other things, the new Regulation requires manufacturers to establish, document, implement and maintain a quality management system.
A quality management system refers to an approved system that documents a company’s functions, processes and resources. Companies need these to mitigate risk and improve the reliability of their products. Also required are criteria and methods for each process that is monitored. A quality management system ensures a company’s ability to always produce safe and effective devices. As manufacturers of medical devices have significant liability for the products they manufacture, they must ensure that the devices achieve their intended level of performance and are safe.
The ISO 13485:2016 standard (Medical devices) is a global quality management system for medical devices. It is intended to be used by the entire organisation and it covers the full product life-cycle from design to manufacture as well as the monitoring of the product’s placing on the market. It is slightly more detailed with regard to requirements concerning product development and production.
The European version of the standard (EN ISO 13485) has been harmonised with the provisions of the Medical Device Directives (MDD, AIMDD, IVDD) and will be harmonized with the provisions of the Regulation. The standard enables companies to comply with the requirements set out in the MD legislations. The standard is suitable for small start-ups that have just begun their operations, as well as for large enterprises. Nevertheless, it should be noted that this standard does not address all the new requirements set out in the Regulation.
An effective quality management system enables manageable processes and predictable outcomes. A company’s senior management is responsible for ensuring that everyone is familiar with the requirements of the quality management system and that these requirements are appropriately implemented throughout the organisation.
DRA’s experts are ready to help your company with any questions related to the Medical Devices Regulation and quality management systems for medical device manufacturers. Please don’t hesitate to contact us!