Both Are Essential — But Not the Same
If you’re in the medical manufacturing field, you’ve probably heard questions like “Are you MDR-compliant?” or “Do you have ISO 13485 certification?” These terms are often used interchangeably—but they represent very different frameworks.
In short: MDR is a legal regulation, while ISO 13485 is a voluntary quality management standard.
This article breaks down the differences in plain language.
What Is MDR?
MDR (Medical Device Regulation) is a European Union law that came into force in 2017 and became mandatory in 2021. It sets strict rules for placing medical devices on the EU market and is a prerequisite for CE marking.
Key MDR requirements:
- Risk-based product classification (Class I to III)
- Technical documentation and conformity assessment
- Clinical evaluation and performance proof
- Unique Device Identification (UDI)
- Post-market surveillance and reporting
- Audits by Notified Bodies (for higher-risk products)
In short, MDR defines what must be done to legally sell a medical device in Europe.
What Is ISO 13485?
ISO 13485 is an international quality management system (QMS) standard developed specifically for medical device manufacturers. It focuses on how a company manages its processes to consistently deliver safe and effective products.
Key ISO 13485 elements:
- Quality policy and objectives
- Document control and traceability
- Risk management and CAPA (Corrective & Preventive Actions)
- Internal audits and management review
- Complaint handling and continuous improvement
ISO 13485 is not a law, but it supports MDR compliance by formalizing best practices.
Key Differences at a Glance
| Aspect | MDR | ISO 13485 |
| Type | Legal regulation | Quality management standard |
| Mandatory | Yes, for CE marking | Not legally required, but recommended |
| Focus | Product safety, labeling, compliance | Organizational process and quality |
| Authority | European Commission & Notified Bodies | International Organization for Standardization (ISO) |
| Output | CE marking, EU Declaration of Conformity | ISO 13485 certification from accredited body |
How Do They Work Together?
The most effective way to comply with MDR is to build your systems on ISO 13485. Why?
- ISO 13485 gives structure to your technical documentation
- It helps with risk management, traceability, and clinical evaluation
- During audits, it ensures your procedures are organized, documented, and defensible
Conclusion
MDR and ISO 13485 are complementary—not interchangeable. One governs your product’s legal market access, the other validates your internal ability to manufacture it reliably.
For any manufacturer aiming to access the European market, understanding both is critical.
At Konum Engineering, our machines are designed for compliance: they integrate easily with ISO 13485 systems and meet the operational needs required by MDR. With the right planning, you can accelerate both certification and market entry.
