What is the difference between EN iso and ISO 13485

When it comes to quality management systems for medical devices, two standards that often come up are EN iso and ISO 13485. Although they both have similar aims, there are some key differences between them. In this article, we will explore these differences in detail.

The Basis of the Standards

The first major difference lies in the basis of the standards. EN iso is derived from the ISO 13485 standard, which serves as a foundation for the European Union's regulatory requirements. It aligns with the Medical Device Directive (MDD) and the new Medical Device Regulation (MDR). ISO 13485, on the other hand, is an international standard developed by the International Organization for Standardization (ISO).

Certification and Compliance

A significant distinction between EN iso and ISO 13485 is related to certification and compliance. EN iso certification is required for companies wishing to sell their medical devices in the European Union, whereas ISO 13485 certification is recognized worldwide. Companies seeking the EN iso certification must undergo additional audits and comply with specific European Union regulations.

Regional Differences and Harmonization

Another important aspect to consider is the regional differences and harmonization efforts. EN iso focuses on meeting the unique requirements and regulations set by the European Union, while ISO 13485 takes a more global perspective. However, there have been efforts to harmonize these standards to minimize inconsistencies and facilitate global market access for medical device manufacturers.

Conclusion

In summary, the difference between EN iso and ISO 13485 lies in their basis, certification requirements, and scope of regional coverage. While EN iso caters specifically to the European Union's regulatory framework, ISO 13485 has a broader global recognition. Both standards are essential for ensuring the quality and compliance of medical devices, but understanding their differences is crucial for manufacturers aiming to penetrate specific markets or gain worldwide acceptance.