What is the difference between ISO 13485 and EU MDR ?

Medical device industry is regulated by various standards and guidelines to ensure safety, quality, and effectiveness of medical devices. Two important standards are ISO 13485 and EU MDR (Medical Device Regulation). While both standards aim to ensure the safety and quality of medical devices, there are significant differences between the two.

ISO 13485: Quality Management System for Medical Devices

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 not mandatory for all medical device manufacturers, but it is widely regarded as a benchmark for ensuring product quality and regulatory compliance.

Understanding ISO 13485:2016

ISO 13485:2016 is an updated version of the ISO 13485 standard that introduces new requirements and improvements to the existing framework. The standard covers six key areas, including:

* Leadership: This area includes the organization's overall strategy and direction, including the management system in place to achieve the standard.

* Management: This area includes the processes and procedures that are in place to manage the organization's activities, including the management system.

* Design and Development: This area includes the processes and procedures that are in place to ensure that new medical devices are designed and developed to meet customer needs and regulatory requirements.

* Verification and Validation: This area includes the processes and procedures that are in place to verify that medical devices meet regulatory requirements and validate their design and performance.

* Documentation: This area includes the processes and procedures that are in place to ensure that records and documentation are accurate and up-to-date.

* Change Management: This area includes the processes and procedures that are in place to manage changes to the medical device design, including changes to the management system.

The Relationship between MDR and ISO 13485

While 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.

In conclusion, ISO 13485 and EU MDR are both important standards for medical device manufacturers. While they share common goals, they have distinct requirements and should be understood in their entirety to ensure compliance with both regulations.