What is the difference between EN ISO and ISO 13485

Introduction:

ISO 13485:2016 is an international standard that specifies requirements for a quality management system in medical devices. The EN ISO 13485 is the European adoption of this standard, with additional requirements specific to the European Union (EU) medical device regulations.

Differences in Scope:

The main difference between EN ISO and ISO 13485 lies in their scope of application. ISO 13485 is recognized globally and is applicable to all organizations involved in the design, development, production, installation, and servicing of medical devices. On the other hand, EN ISO 13485 not only encompasses the ISO 13485 requirements but also includes additional European regulatory requirements such as the EU Medical Device Directive or In Vitro Diagnostic Device Directive.

Differences in Regulatory Compliance:

Another significant difference between EN ISO and ISO 13485 is the level of regulatory compliance they address. ISO 13485 aims to ensure compliance with international regulations, while EN ISO 13485 ensures conformity with both international regulations and the additional European directives. This means that organizations complying with EN ISO 13485 fulfill the requirements for the CE marking in Europe, allowing them to legally market their medical devices within the EU member states.

Differences in Documentation:

EN ISO 13485 places more emphasis on documentation compared to ISO 13485. The European standard requires organizations to maintain additional documentation related to the European regulatory requirements. These may include technical files, clinical evaluation reports, risk management documentation, and post-market surveillance data specific to the EU market. ISO 13485, however, provides a framework for general documentation requirements without the need for specific documentation related to EU regulations.

In conclusion, while both EN ISO and ISO 13485 share the same core requirements for the quality management system in medical devices, the EN ISO variant encompasses additional European regulatory requirements. Organizations seeking compliance with European directives and CE marking should adopt EN ISO 13485, whereas organizations focusing on global market access may choose to comply with ISO 13485 alone.