Understanding MDR Compliance and ISO 13485
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What is MDR Compliance? MDR compliance refers to adherence to the European Union Medical Device Regulation 2017/745 (EU MDR 2017/745) by medical device manufacturers. It involves meeting necessary regulations and requirements to ensure the safety and efficacy of medical devices in the European Union market.
What is ISO 13485? ISO 13485 is an internationally recognized standard for creating a Quality Management System (QMS) for medical device companies worldwide. By implementing ISO 13485, manufacturers can ensure their QMS process consistently meets customer and regulatory requirements.
Achieving MDR Compliance
The EU MDR sets rules and standards for medical devices sold within the EU. To achieve MDR compliance, manufacturers must ensure their devices meet the General Safety and Performance Requirements (GSPRs) outlined in Annex I of the regulation. These requirements cover aspects such as design, manufacturing, labeling, clinical evaluation, risk management, post-market surveillance, and more.
Achieving MDR compliance requires a comprehensive understanding of regulatory requirements, diligent planning, and implementation of appropriate processes and systems. Manufacturers must stay updated with the latest developments and guidance from regulatory authorities to maintain ongoing compliance.
ISO 13485 and EU MDR
Foundation for Compliance ISO 13485 provides a solid foundation for meeting the Quality Management System requirements of the EU MDR. Although ISO 13485 is not directly referenced in the EU MDR, it is the only QMS standard listed in the EU’s harmonized standards for medical devices. This recognition makes ISO 13485 an essential framework for implementing a QMS that aligns with EU MDR requirements.
ISO 13485 vs. EU MDR
Safety and Performance: Ensured through proper documentation and adherence to standards.
Management Responsibility: Involves top management’s commitment to the QMS.
Resource Management: Adequate resources for maintaining QMS.
Risk Management: Identifying and mitigating risks in the product lifecycle.
Clinical Evaluation: Assessing safety and performance based on clinical data.
Components of MDR Compliance
Classification: Determine the risk class of your medical device according to EU MDR classification rules.
Conformity Assessment: Conduct a procedure based on the risk class, which may involve a notified body.
Technical Documentation: Prepare and maintain detailed documentation demonstrating compliance with GSPRs.
Quality Management System: Implement a QMS ensuring compliance with EU MDR requirements.
Clinical Evaluation: Conduct thorough evaluations considering clinical data, scientific literature, and post-market surveillance data.
EU MDR Quality Management System
Manufacturers must have a QMS in place to comply with EU MDR. This system needs to be audited by a notified body to certify medical devices. For certification and CE marking, a company must have a QMS.
MDR QMS Requirements and ISO 13485
In Article 10 of the EU MDR, the regulation specifies the QMS requirements, most of which are covered by ISO 13485. Here are some examples:
| EU MDR QMS Requirements | ISO 13485 Clause |
|---|---|
| A strategy for regulatory compliance | 4.1 |
| Safety and performance | 7.5 |
| Management responsibility | 5.1, 5.5 |
| Resource management | 7.4 |
| Risk management | 7.3 |
| Clinical evaluation | 7.3 |
| Product realization | 7 |
| Verification of Unique Device Identity assignment | 7.5.8, 7.5.9 |
| Post-market surveillance system | 8.2.1, 8.2.2 |
| Communication with authorities | 8.2.3 |
| Incident reporting | 8.2.3 |
| Corrective and preventive actions | 8.5.2, 8.5.3 |
| Monitoring and measurement, data analysis, and product improvement | 8.2 |
Is ISO 13485 Mandatory for MDR?
No, ISO 13485 is not mandatory for EU MDR compliance. However, the EU MDR requires a QMS, and ISO 13485:2016 is the only QMS standard listed in the EU’s harmonized standards. Most companies use ISO 13485 to implement their QMS because it meets MDR requirements.
Achieving MDR Compliance
To achieve MDR compliance, you need a deep understanding of MDR and its requirements. This includes diligent planning and implementing appropriate processes and systems. Stay updated with the latest regulatory developments and guidance to maintain ongoing compliance.
Key Elements for MDR Compliance:
Meet GSPRs: Ensure compliance with design, manufacturing, labeling, clinical evaluation, risk management, and post-market surveillance.
Implement QMS: Use ISO 13485 to create a robust QMS that supports MDR compliance.
Impact of MDR on a QMS
How Does EU MDR Impact a QMS Implemented According to ISO 13485?
To comply with the EU MDR, additional records need to be maintained. For example, ISO 13485 requires a medical device file (clause 4.2.3) with a minimum list of information. However, the EU MDR requires this documentation to include all information stipulated in Annex II and Annex III of the EU MDR for the medical device technical file. The EU MDR also necessitates additional records for post-market surveillance and clinical evaluation. Despite these added records, the processes for creating, updating, and maintaining this documentation will largely remain the same.
Conclusion
You need a QMS to be compliant with the EU MDR. While ISO 13485 is not directly referenced in the EU MDR, it is the only QMS standard listed in the EU’s harmonized standards. Therefore, it is indirectly the most reasonable way to implement a QMS according to the MDR. ISO 13485 provides a comprehensive system devoted to improving quality processes. This is an additional benefit on top of becoming MDR compliant.
