Is ISO 13485 required for MDR ?

The Medical Device Regulation (MDR) has raised several questions regarding its implementation and requirements. One such question is whether ISO 13485 certification is mandatory for compliance with the new regulation. In this article, we will explore this topic in detail and provide a comprehensive analysis.

Understanding ISO 13485

ISO 13485 is an internationally recognized standard that sets out the requirements for a quality management system for medical device manufacturers. It covers various aspects, including risk management, design controls, process validation, and corrective actions. The standard is divided into four parts, ISO 13485:2015, ISO 13485:2018, ISO 13485:2020 and ISO 13485:2021.

ISO 13485:2016 is the current version of the standard and it is widely regarded as a benchmark for ensuring product quality and regulatory compliance. It covers various aspects of medical device manufacturing, including the management of risks, design and development of medical devices, validation of medical devices, and corrective actions.

The Relationship between MDR and ISO 13485

Although ISO 13485 and MDR share common goals of ensuring patient safety and product quality, they are separate entities with distinct requirements. MDR focuses specifically on the marketing and distribution of medical devices in the European Union. Compliance with MDR requires manufacturers to meet specific obligations, such as demonstrating conformity with essential requirements and undergoing conformity assessment procedures.

ISO 13485, on the other hand, provides a framework for implementing an effective quality management system. While ISO 13485 certification is not explicitly required by MDR, it can be beneficial in meeting certain MDR requirements. For example, ISO 13485 can help manufacturers establish and maintain the necessary documentation, procedures, and controls to comply with MDR.

Conclusion

In conclusion, while ISO 13485 certification is not explicitly required by the Medical Device Regulation, it can be beneficial in meeting certain MDR requirements. Compliance with ISO 13485 can provide manufacturers with a framework for implementing an effective quality management system and help ensure that medical devices are of high quality and meet regulatory requirements. Therefore, it is recommended that manufacturers consider obtaining ISO 13485 certification to meet the requirements of the Medical Device Regulation and ensure the safety of patients.