What is the difference between ISO 13485 and EU MDR?

The medical device industry follows various regulations and standards to ensure the safety, quality, and effectiveness of medical devices. Two important standards are ISO 13485 and EU MDR (Medical Device Regulation). While both focus on ensuring 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 international standard that specifies the requirements for a quality management system (QMS) specific to medical devices. The standard helps medical device manufacturers establish and maintain an effective QMS that ensures the consistent production of safe and reliable medical devices.

Some key features of ISO 13485 include:

Emphasis on risk management: ISO 13485 requires manufacturers to implement a risk-based approach throughout the product development lifecycle. This includes identifying potential hazards, assessing risks, and implementing appropriate controls to mitigate them.

Focus on customer satisfaction: The standard emphasizes meeting customer requirements and consistently delivering products that meet or exceed customer expectations.

Regulatory compliance: ISO 13485 helps manufacturers demonstrate compliance with regulatory requirements, making it easier to market their devices globally.

EU MDR: New Regulations for Medical Devices in Europe

The EU MDR is a regulation that replaces the Medical Device Directive (MDD) and applies to all medical devices sold in Europe. It aims to enhance patient safety and improve overall transparency in the medical device industry.

Some key differences introduced by EU MDR include:

Expanded scope: EU MDR has a broader scope compared to MDD and now includes additional products such as certain cosmetic devices and products with a non-medical intended purpose but still have a medical effect.

Stricter classification rules: The new regulation introduces stricter and clearer rules for the classification of medical devices. Some devices that were previously considered low-risk may now fall into higher risk categories, requiring more extensive conformity assessments.

Increased clinical evidence requirements: EU MDR emphasizes the importance of clinical data to support the safety and performance of medical devices. Manufacturers will have to provide more comprehensive clinical evidence, including post-market surveillance data.

Conclusion

In summary, ISO 13485 focuses on ensuring a robust quality management system, emphasizing risk management and regulatory compliance, whereas EU MDR introduces new regulations specific to medical devices sold in Europe, with an expanded scope and stricter requirements for device classification and clinical evidence. Compliance with both standards is essential for medical device manufacturers looking to ensure the safety, quality, and effectiveness of their products in the global market.