Drugdu.com expert's response:

Under the EU MDR, the quality management system requirements for manufacturers are not limited to “production process compliance.” Manufacturers are expected to establish a quality management system that covers the full lifecycle of medical devices.

In simple terms, the QMS should demonstrate that the product remains under continuous control from design and development, production and release, through to post-market feedback and risk control.

The key requirements can be summarized in five areas:

1. Establish a quality management system that meets MDR requirements

Manufacturers need to establish, implement, maintain and continuously improve their QMS. The system should cover processes such as product design and development, production, inspection, release, supplier management, document control, change control, nonconforming product handling, CAPA, internal audits and management review.

2. Include regulatory compliance in the QMS

The QMS should clearly define product classification, conformity assessment routes, applicable standards, evidence of compliance with the General Safety and Performance Requirements (GSPR), technical documentation maintenance and CE certification requirements. Companies should not only have an ISO 13485 system, but also be able to demonstrate how their products meet MDR requirements.

3. Apply risk management throughout the product lifecycle

The MDR requires manufacturers to carry out continuous risk management. Risk management is not simply a document prepared before registration. It should be updated based on production issues, complaints, adverse events, clinical data and post-market feedback.

4. Establish a systematic post-market surveillance and vigilance process

Manufacturers need to establish a post-market surveillance (PMS) system, including complaint handling, user feedback collection, PMCF, PMS reports or PSURs, adverse event reporting, recalls and field safety corrective actions. Post-market data should also be used to update risk management, clinical evaluation and technical documentation.

5. Control outsourced activities and suppliers

Even if design, production, sterilization, testing or packaging activities are outsourced, the manufacturer remains responsible for product compliance. Therefore, the QMS must include supplier audits, quality agreements, change notification requirements, incoming material control and outsourced process management.

In summary, under the MDR, a QMS is not merely a production quality system. It is a full lifecycle management system covering regulatory compliance, risk management, clinical evaluation, post-market surveillance and supply chain control.