What is the difference between ISO 13485 and EN ISO 13485?

ISO 13485 and EN ISO 13485 are both standards that focus on the quality management systems for medical devices. While they share many similarities, there are some key differences between the two. In this article, we will explore these differences in an easy-to-understand manner.

Scope and Applicability

ISO 13485 is an international standard developed by the International Organization for Standardization (ISO). It provides a framework for establishing, implementing, and maintaining a quality management system specific to the medical device industry. This standard is applicable to organizations involved in the design, manufacturing, distribution, and servicing of medical devices.

On the other hand, EN ISO 13485 is a harmonized European standard derived from ISO 13485. It incorporates additional requirements specific to the European Union (EU). This means that compliance with EN ISO 13485 is necessary for CE marking, which allows medical devices to be sold within the EU market. However, it should be noted that compliance with ISO 13485 is also a requirement for gaining certification under EN ISO 13485.

Regulatory Framework

ISO 13485 is recognized globally and is widely used as a benchmark for quality management in the medical device industry. It ensures that organizations meet regulatory requirements and demonstrate their commitment to producing safe and effective medical devices.

EN ISO 13485, in addition to the requirements of ISO 13485, aligns with EU regulatory directives such as the Medical Devices Directive (MDD) and the In-vitro Diagnostic Devices Directive (IVDD). Compliance with these directives is essential for manufacturers seeking market access within the EU. Therefore, organizations that wish to commercialize their medical devices in Europe must comply with the additional requirements specified in EN ISO 13485.

Documentation and Language

ISO 13485 specifies the documentation requirements for a quality management system. However, it does not dictate the language in which the documentation should be written. Therefore, organizations can choose to use any language they prefer when documenting their quality management system under ISO 13485.

In contrast, EN ISO 13485 requires that all documents related to the quality management system, including labeling and instructions for use, be provided in an official language of the EU member state(s) where the medical device is intended to be sold or used. This ensures that the end-users can understand and follow the instructions accurately, promoting patient safety within the European market.

Conclusion

In summary, ISO 13485 and EN ISO 13485 are similar in many aspects but differ in terms of scope, regulatory framework, and documentation requirements. ISO 13485 serves as a global standard for quality management systems in the medical device industry, while compliance with EN ISO 13485 is necessary for accessing the European market. Understanding these differences is crucial for organizations involved in the manufacturing and distribution of medical devices, as they need to ensure compliance with the appropriate standard(s) based on their target market(s).