For manufacturers of medical devices in the EU, a compliant Quality Management System (QMS) is not just a formality, it’s a legal requirement. Under the EU Medical Device Regulation (MDR 2017/745), manufacturers are obligated to implement, maintain, and continuously improve a QMS that ensures compliance with legal and performance standards.
Strictly speaking, ISO 13485 certification is not a legal requirement for CE marking under MDR. However, it is highly recommended and frequently used by Notified Bodies as strong evidence that your processes fulfill MDR expectations. For most companies, aligning their QMS with ISO 13485 is the most practical and accepted approach.
A compliant QMS ensures that your medical device consistently meets safety, performance, and documentation standards. But what does that actually involve?
- Regulatory Compliance
- General Safety & Performance Requirements (GSPR)
- Management Responsibility
- Resource Management
- Risk Management
- Clinical Evaluation & PMCF
- Product Realization
- UDI Assignment
- Post-Market Surveillance (PMS)
- Regulatory Communication
- Vigilance System
- CAPA Management
- Monitoring, Data & Continuous Improvement
For devices of Class Is, Im, Ir, IIa, IIb and III, QMS certification by a Notified Body is mandatory. Even for Class I devices, a functioning and documented QMS is required to demonstrate MDR compliance.
Need support in setting up or optimizing your QMS?
Get more information: Quality Management for Medical Device Manufacturers & Quality Management System ISO 13485 Compliance or contact us for a consultation.
Our team helps you build a compliant, audit-ready system tailored to your risk class and product type.
