EU MDR Quality Management System (QMS)

A Quality Management System (QMS) is a structured framework that documents processes, procedures, and responsibilities to ensure products or services meet regulatory and customer requirements. QMS integrates documented procedures, responsibilities, and processes to achieve quality objectives, manage risks, and ensure product lifecycle compliance.

The European Union Medical Device Regulation (EU MDR), also known as Regulation (EU) 2017/745, governs the manufacture, distribution, and post-market oversight of medical devices within the EU. The regulation mandates that all medical devices sold in the EU meet stringent safety, performance, and quality requirements throughout their lifecycle.

The key QMS requirements under EU MDR, primarily outlined in Article 10(9), include establishing a strategy for regulatory compliance, ensuring the safety and performance of devices, and defining management responsibilities. Other requirements include resource management, risk management, clinical evaluation and evidence, product realization, and assignment of Unique Device Identification (UDI). The QMS must also incorporate a Post Market Surveillance (PMS) system, communication protocols with authorities, vigilance corrective and preventive actions (CAPA), and data analysis to support continuous improvement.

To comply with EU MDR QMS requirements, manufacturers must develop a structured, risk-based QMS. The QMS must align with applicable EU MDR articles and annexes and integrate a documented regulatory compliance strategy. The QMS must include risk management and clinical evaluation procedures, documented processes for post-market surveillance and post-market clinical follow-up, and controls for UDI management. Manufacturers must conduct internal audits and management reviews, oversee suppliers and subcontractors, train staff, and maintain audit readiness to ensure ongoing conformity.

Many medical device companies leverage electronic Quality Management Systems (eQMS) to ensure compliance with EU MDR. An eQMS automates quality workflows, centralizes documentation, enables real-time oversight, and maintains traceability across all quality processes. Features such as automated CAPA, risk management, and PMS tracking allow manufacturers to enhance efficiency, reduce human error, and improve audit readiness.

SimplerQMS offers a fully validated eQMS solution designed for medical device companies. SimplerQMS supports compliance with EU MDR, ISO 13485, FDA 21 CFR Part 11, and EU GMP by helping organizations meet regulatory and QMS requirements through built-in modules and workflow automation.

Book a demo with our Quality Solutions Consultant today to discover how SimplerQMS can elevate your quality processes and help ensure EU MDR compliance.

What Is EU MDR?

The European Union Medical Device Regulation (EU MDR), also known as Regulation (EU) 2017/745, governs the production, distribution, and monitoring of medical devices in the EU. Replacing the earlier Medical Device Directive (MDD 93/42/EEC) and Active Implantable Medical Device Directive (AIMDD 90/385/EEC), EU MDR became fully applicable on 26 May 2021.

The primary purpose of the EU MDR is to ensure that medical devices marketed in the EU are safe, effective, and manufactured under consistent, high-quality standards. EU MDR introduces stricter requirements for risk management, clinical evaluation, post-market surveillance (PMS), and transparency, thereby enhancing patient safety and device reliability.

EU MDR is a comprehensive document with 10 chapters, 123 articles, and 17 annexes. Key focus areas include updated device classification rules (in particular for implantable devices, active devices, and software), conformity assessment, clinical evidence requirements, Post-Market Clinical Follow-Up (PMCF), vigilance, and Unique Device Identification (UDI) for traceability.

Compliance with EU MDR is mandatory for obtaining CE Marking, which is required for legal medical device marketing in the EU. All economic operators, including manufacturers, importers, distributors, and authorized representatives, must align with EU MDR across the medical device lifecycle. For instance, implementing a robust, compliant QMS is a legal requirement to maintain conformity and ensure continuous monitoring of product performance and safety.

What Are the EU MDR QMS Requirements?

The main EU MDR QMS requirements outlined in Article 10(9) and supported by Annex IX are regulatory compliance, conformity of medical devices, management responsibility, and resource management. Other EU MDR requirements include risk management, clinical evaluation data, post-market clinical follow-up, UDI requirements, communication protocols, and corrective and preventive action (CAPA) management.

The purpose of EU MDR QMS requirements is to ensure consistent design, production, and post-market surveillance (PMS) of medical devices.

The key QMS requirements, as outlined in EU MDR Article 10(9) and supported by Annex IX, are listed below.

• Strategy for Regulatory Compliance: Under EU MDR, a QMS must include an approach or strategy to maintain conformity with EU MDR requirements and avoid regulatory risks.
• Safety and Performance of Medical Devices: Medical device companies must ensure that their QMS aligns with the fulfillment of the intended use of a medical device without compromising patient or user safety.
• Management Responsibility: Under EU MDR, a QMS must include processes for leadership oversight for compliance, quality culture, and resource assignment for QMS operations.
• Resource Management: Under EU MDR, QMS must address adequate resource management to ensurethe provision of skilled personnel, appropriate infrastructure, and ongoing training to maintain an effective and compliant QMS. This also includes the selection, control, and monitoring of suppliers and contractors to ensure they meet regulatory and quality requirements.
• Risk Management: The QMS under EU MDR must systematically address the identification, analysis, evaluation, control, and monitoring of risks throughout the entire medical device lifecycle.
• Clinical Evaluation: Assessment of clinical data to support safety and performance claims under EU MDR QMS requirements.
• Product Realization (Planning, Design, Development, Product, and Service): Medical device companies must ensure that their QMS aligns with end-to-end control from design to delivery to ensure compliant and effective medical devices.
• Unique Device Identity Assignment: The QMS must include procedures for properassignment and traceability of UDI.
• Post-Market Surveillance (PMS) System: Astructured mechanism to gather, record, and analyze data on device performance and incidents following market release as part of the EU MDR QMS.
• Communication: Medical device companies must ensure the QMS a process for effective external communication, in particular, timely and accurate reporting with competent authorities and notified bodies.
• Vigilance: Under EU MDR, the QMS must include protocols forreporting serious incidents and field safety actions within mandated timelines.
• Corrective Actions and Preventive Actions: The QMS must facilitatethe identification, investigation, and resolution of nonconformities and potential nonconformities, along with verification of CAPA effectiveness to prevent issue recurrence.
• Monitoring and Measurement, Data Analysis, and Product Improvement: Data must be systematically gathered and analyzed to monitor performance, ensure conformity, and drive continual improvement under EU MDR QMS requirements.

Strategy for Regulatory Compliance

EU MDR Article 10(9)(a) requires manufacturers to establish and maintain a documented strategy for regulatory compliance. This strategy should ensure compliance of the medical device to applicable regulatory requirements throughout the product lifecycle. The strategy for regulatory compliance should also ensure adherence to conformity assessment procedures and manage changes that affect compliance.

The strategy includes procedures to identify applicable requirements and to control and document how they are met. Manufacturers implement this strategy through QMS, which integrates regulatory planning, change control, and audit readiness.

Some companies use QMS software to enhance efficiency and help maintain compliance. QMS software provides a centralized document repository while enabling automated workflows that streamline processes and support effective oversight.

Safety and Performance of Medical Devices

The EU MDR mandates that manufacturers ensure the safety and performance of medical devices throughout their lifecycle, by meeting applicable General Safety and Performance Requirements (GSPR) as specified in Article 10(9)(b) and Annex I.

This requirement ensures that the medical devices are designed and manufactured in a way that guarantees patient and user safety. This requirement also ensures that devices consistently achieve intended performance and minimizes risks to patients and users. The safety and performance of medical devices are demonstrated through the conformity assessment, clinical evaluation, risk management, and PMS processes.

Manufacturers must implement and document procedures to check and review design outputs and manufacturing processes and confirm ongoing device performance through clinical evidence and post-market data. Required documentation includes the Declaration of Conformity, technical files, and evidence demonstrating alignment with the GSPR checklist.

To fulfill these safety and performance requirements, companies can utilize tools such as ISO 14971-based risk management procedures, clinical evaluation plans, and design verification protocols.

QMS software supports control of records, monitors real-time performance, and manages updates across the product lifecycle.

Management Responsibility

EU MDR Article 10(9)(c) requires manufacturers to assign executive accountability for implementing and maintaining the QMS. Management responsibility reinforces leadership’s role in ensuring medical device safety, regulatory conformity, and lifecycle control.

Management’s responsibility includes providing adequate resources, strong leadership, and effective oversight mechanisms to support compliance and drive continuous improvement.

Manufacturers must define and document management roles, responsibilities, and authorities, with structured processes for management reviews, setting quality objectives and appointing the Person Responsible for Regulatory Compliance under Article 15. Decision records and review outcomes must support these management responsibilities.

Companies typically meet management responsibility obligations using SOPs and documented management review processes. Additionally, leadership engagement is demonstrated through ongoing analysis of key performance indicators (KPIs), CAPA trends, and audit findings.

QMS software can be used to serve as a centralized repository for meeting minutes, action plans, and KPIs, ensuring efficient tracking and management.

Resource Management

EU MDR Article 10(9)(d) mandates that resource management be addressed within the QMS framework. Manufacturers should establish and maintain procedures to ensure sufficient and competent personnel, appropriate infrastructure, and adequate facilities are available to support an effective QMS. The resource management requirement also includes the selection and control of suppliers and subcontractors to ensure external resources used in the manufacture of medical devices also meet regulatory, quality, and safety requirements.

Resource management contributes to medical device safety, regulatory compliance, and operational efficiency by ensuring that all processes are supported by trained and qualified staff. Furthermore, resource management checks for adequate resources necessary for consistent quality outcomes. Manufacturers must provide the necessary infrastructure and facilities to develop and manufacture medical devices in compliance with the MDR.  

Manufacturers are expected to document procedures for training, competency assessment, infrastructure management, and resource planning. Resource management further includes maintaining training records, ensuring access to updated procedures, and verifying that personnel performing tasks are qualified.

To meet resource management requirements, companies typically use training management systems and resource planning tools. Best practices include role-based training matrices, scheduled refresher training, and infrastructure maintenance logs to support audit readiness and ensure the safety and performance of the device.

QMS software can automate training assignments, track qualifications, and ensure controlled access to current procedures.

Risk Management

Under Article 10(9)(e) and as set out in Section 3 of Annex I of EU MDR, risk management is a mandatory, continuous, and auditable process integrated into the QMS. EU MDR mandates that medical device manufacturers establish a systematic risk management process covering the entire product lifecycle.

The core function of risk management is to ensure that all known and foreseeable risks are identified, evaluated, controlled, and monitored to maintain a favorable benefit-risk ratio, in alignment with the General Safety and Performance Requirements (GSPRs) under Annex I.

Manufacturers must implement a risk management plan, identify potential hazards including misuse scenarios, assess risks in both normal and fault conditions, and apply and verify risk control measures.

A risk management file should be kept up to date to show what risks were identified, how they were reduced, and why any remaining risks are considered acceptable.

Clinical Evaluation

The clinical evaluation requirement under EU MDR Article 10(9)(f) and Article 61, elaborated in Annex XIV Part A Clinical Evaluation,mandates that manufacturers establish and maintain procedures to continuously evaluate and document clinical data.

The clinical evaluation requirement is critical for ensuring that the device performs as intended, complies with the applicable GSPR, and that the clinical benefits outweigh any risks. Clinical evaluation supports patient safety, regulatory compliance, and informed decision-making throughout the product lifecycle.

Manufacturers must implement a Clinical Evaluation Plan (CEP) and compile a Clinical Evaluation Report (CER), supported by clinical data from investigations, scientific literature, or post-market clinical follow-up (PMCF) activities. These documents must be reviewed regularly and updated in line with PMS findings or changes in the device design or intended use.

To meet clinical evaluation requirements, companies typically use SOPs for clinical evaluation and templates for the supporting documentation such as CERs, CEPs, and PMCF.

QMS software can be used to track updates, link documentation, and maintain version control of clinical evaluation, evidence, and other relevant documents.

Product Realization (Planning, Design, Development, Product, and Service)

The product realization requirement, as referenced in EU MDR Article 10(9)(g) and Annex I (GSPR), mandates that manufacturers establish and maintain procedures for the planning, design, development, production, and servicing of medical devices.

This product realization requirement guarantees control, traceability, and alignment with safety, performance, and regulatory expectations, minimizing design-related risks and supporting overall compliance.

Medical device manufacturers must document a structured design and development plan addressing design inputs, design outputs, risk management integration, verification and validation, and clinical evaluation. Design transfer procedures ensure effective translation of specifications into production processes. During production, procedures must extend to production and process controls, traceability, and change management, with strong linkage to technical documentation and QMS records to demonstrate ongoing compliance.

Companies meet product realization requirements using design control SOPs, project planning tools, risk management procedures, and cross-functional collaboration. These requirements are to ensure that medical devices are developed, validated, and brought to market in compliance with regulatory and quality specifications.

QMS software helps manage design history files, design changes, design reviews, and other medical device technical files related to product realization.

Unique Device Identity Assignment

The Unique Device Identity (UDI) assignment requirement is referenced under EU MDR Article 10(9)(h), Article 27 and Annex VI Part C. The UDI System mandates that manufacturers assign and maintain a UDI for each medical device and applicable packaging levels.

UDI is a critical medical device lifecycle management and regulatory compliance component, designed to enhance traceability, post-market surveillance, and patient safety. UDI enables accurate device identification, supports field safety corrective actions, and facilitates reporting of serious incidents and trends.

Manufacturers must implement documented procedures for UDI assignment, ensure correct labeling on devices and packaging, and register the UDI in EUDAMED. These procedures must detail how UDI-DI and UDI-PI are generated, maintained, and linked to technical documentation.

Companies meet these UDI requirements using labeling control SOPs, UDI assignment tools, and QMS software that integrates UDI generation, UDI database, and recordkeeping.

Post-Market Surveillance (PMS) System

The PMS system requirement, as defined in EU MDR Articles 83–86 and referenced in Article 10(9)(i), mandates that manufacturers establish and maintain a PMS system within their QMS. PMS is the systematic collection, recording, and analysis of data on device performance following its release onto the market.

PMS is critical for identifying safety concerns, verifying ongoing performance, and promptly detecting risks or non-conformities. Post-market surveillance supports regulatory compliance and medical device safety by informing clinical evaluation updates, risk management, and CAPA processes.

Manufacturers must implement a PMS plan per device or family, define data sources such as user feedback and incident reports, and document findings in a PMS Report (Class I) or Periodic Safety Update Report (PSUR) for Class IIa and higher. These reports must be available to competent authorities and notified bodies upon request.

Companies meet PMS obligations using SOPs and structured data collection tools. While there are best practices in place, usage of QMS software can be efficient to manage PMS.

For instance, QMS software helps to connect PMS outputs with risk and clinical evaluation records, track trends, and automate alerts.

Communication

EU MDR Articles 10(9)(j), 10(14), and 87–90 require that the QMS addresses external communication between manufacturers, competent authorities, Notified Bodies, other economic operators, and customers. Manufacturers must establish and maintain procedures that ensure timely, accurate, and transparent communication. These procedures must address reporting on device performance, safety incidents, and regulatory compliance to support continuous oversight and public health protection.

The requirement for communication with authorities is essential for maintaining regulatory trust, enabling prompt responses to safety concerns, and supporting compliance throughout the lifecycle. Communication allows authorities to monitor market behavior and coordinate necessary corrective actions.

Manufacturers must implement procedures for reporting serious incidents, field safety corrective actions (FSCAs), and adverse trends while ensuring readiness to provide documentation or updates upon request. Clear roles and responsibilities for these communications must be defined and maintained.

Best practices include appointing a regulatory liaison such as the Person Responsible for Regulatory Compliance (PRRC), utilizing submission templates, and integrating EUDAMED reporting into standard workflows.

Furthermore, companies typically meet this requirement using vigilance SOPs and regulatory communication logs.

QMS software supports communication with authorities by streamlining report submissions, tracking deadlines, and maintaining an audit trail of all interactions.

Vigilance

The incident reporting requirement, as outlined in EU MDR Article 87 and linked to the QMS under Articles 10(9)(k), 10(13), mandates that manufacturers establish and maintain procedures to report serious incidents and field safety corrective actions (FSCAs) to competent authorities within defined timelines.

This incident reporting requirement is essential for protecting patient safety, supporting regulatory transparency, and enabling timely corrective measures. Incident reporting reinforces lifecycle vigilance by identifying and addressing emerging risks, CAPA, and PMS activities.

Manufacturers must document clear procedures for incident identification, reportability assessment, and communication, typically within 2, 10, or 15 days based on severity. These procedures must align with PMS systems, including root cause analysis and follow-up actions.

Companies meet these requirements using vigilance-related SOPs, complaint management systems, and CAPA logs.

QMS software supports incident reporting with automated workflows that track reportable events, assign responsibilities, and enforce deadline compliance.

Corrective Actions and Preventive Actions

EU MDR Article 10(9)(l) requires manufacturers to establish and maintain CAPA procedures. CAPA procedures must identify and investigate nonconformities, and implement corrective or preventive actions. Manufacturers must verify and document the effectiveness of these actions to ensure sustained compliance and system improvement.

CAPA requirements are fundamental for maintaining medical device safety, and regulatory compliance, and supporting continuous improvement throughout the product lifecycle by systematically addressing problems and preventing their recurrence or occurrence.

To meet CAPA requirements, manufacturers are expected to implement a structured CAPA process that includes issue detection, root cause analysis, action planning, execution, effectiveness verification, and comprehensive documentation. CAPAs must be linked to data sources such as complaints, audit findings, non-conformities, vigilance activities, and PMS results.

Moreover, medical device companies implement CAPA management by using CAPA SOPs, and root cause analysis tools like 5 Whys, and Fishbone diagrams.

The use of QMS software helps assign responsibility, track deadlines, verify outcomes, and maintain a complete audit trail.

Monitoring and Measurement, Data Analysis, and Product Improvement

The monitoring and measurement, data analysis, and product improvement requirements addressed in EU MDR Article 10(9)(m) mandate that manufacturers establish and maintain procedures to measure and monitor quality performance. Monitoring and measuring data include analyzing relevant data and driving continuous improvement in product and process effectiveness.

The requirement to monitor and measure output ensures that data-driven insights are leveraged to enhance medical device safety, support regulatory compliance, and improve operational efficiency across the product lifecycle. The monitoring and measurement requirement promotes proactive quality management by identifying trends, risks, and opportunities for improvement.

Manufacturers must implement systematic methods for collecting and analyzing data from complaints, non-conformities, audits, PMS, and CAPA. Data should also be obtained from the monitoring and measuring of process and product characteristics. Insights should inform management reviews, trigger actions, and guide design and risk updates.

Companies use data analysis SOPs, performance dashboards, and data analysis tools to gather valuable insights for continuous improvement.

Some companies use QMS software to aggregate inputs across functions. For example, QMS software allows the creation of KPI reports, the export of data, and the tracking of KPIs.

How to Ensure Medical Device QMS Compliance With EU MDR?

Ensuring QMS compliance with the EU MDR requires establishing and maintaining a documented, risk-based quality system aligned with Article 10(9) requirements and relevant annexes of Regulation (EU) 2017/745. The medical device QMS must help guarantee that each medical device consistently meets safety, performance, and regulatory requirements throughout its lifecycle.

To ensure QMS compliance with EU MDR, medical device manufacturers must consider the steps listed below.

1. Establish an MDR-Compliant QMS Framework: Develop a structured EU MDR QMS framework aligned with the scope and structure defined in the EU MDR, including device classification. The system must include policies, defined processes, work instructions, and records. Clearly define roles and responsibilities, including the Person Responsible for Regulatory Compliance (PRRC).
2. Implement Regulatory Strategy and Risk Management: Integrate processes, including risk management procedures, that demonstrate conformity with EU MDR.
3. Document Clinical Evaluation and Post-market Surveillance (PMS) Procedures: Define clinical evaluation, vigilance and PMS processes, including post-market clinical follow-up (PMCF), to continuously assess medical device performance and safety. Ensure clinical evidence demonstrates conformity with GSPRs.
4. Ensure UDI System Integration: Align your QMS with EU MDR Article 27 by integrating the management processes for UDI-DI (device identifier) and UDI-PI (production identifier).
5. Maintain up-to-date Technical Documentation: Maintain and control technical documentation, such as design files, verification/validation reports, risk management, andclinical evaluation, that meet EU MDR Annex II and III requirements.
6. Qualify and Monitor Suppliers and Contractors: Establish supplier evaluation, selection, and monitoring criteria. Maintain quality agreements and records to ensure external parties comply with regulatory and QMS requirements.
7. Train Personnel on MDR Requirements: Develop training matrices and keep training records as part of QMS documentation. Staff must be able to demonstrate awareness of EU MDR obligations.
8. Maintain CAPA System: Implement a CAPA process to handle issues such as deviation, nonconformance, complaint, and audit findings. Ensure root cause analysis, effectiveness checks, and documentation are in place.
9. Conduct Internal Audits and Management Reviews: Conduct regular internal audits and management reviews to assess QMS effectiveness, identify gaps, and drive continuous improvement.
10. Prepare for Notified Body Assessment: Ensure all QMS elements (e.g. technical documentation, training records, CAPA logs, PMS files) are audit-ready for scheduled or unannounced audits or inspections.

How Do EU MDR QMS Requirements Differ From EU IVDR?

The main difference between EU MDR and EU IVDR (Regulation (EU) 2017/746) QMS in terms of QMS requirements is the scope of products, classification systems, and the level of evidence needed to demonstrate product conformity.

EU MDR regulates medical devices such as implants and surgical tools, while EU IVDR governs in vitro diagnostics (IVD), or medical devices used to test biological samples obtained from the body to assess health conditions. IVD includes reagents, diagnostic software, and blood tests. Consequently, QMS processes must be tailored to device-specific functions and environments.

EU MDR uses a Class I–III risk classification, while EU IVDR introduces a more granular Class A–D system, significantly increasing the number of IVDs requiring Notified Body involvement and deeper QMS oversight.

Regarding technical documentation requirements, EU MDR emphasizes clinical evaluation and general safety and performance of medical devices. EU IVDR, on the other hand, requires detailed performance evaluation reports that include analytical performance, scientific validity, and clinical performance of IVDs.

Both EU MDR and EU IVDR require manufacturers to implement a risk-based QMS aligned with EN ISO 13485.

Manufacturers transitioning from MDD or IVDD must align their QMS with new classification rules, expanded regulatory scope, and stricter PMS, vigilance, and UDI requirements. For IVD manufacturers, IVDR mandates full QMS implementation, Notified Body involvement, and continued ISO 13485 alignment to ensure compliance and market access.

How Do EU MDR QMS Requirements Differ From ISO 13485?

The main difference between EU MDR and ISO 13485 in terms of QMS requirements lies in their scope and purpose. ISO 13485 is a globally recognized quality standard for medical devices, while EU MDR is a legally binding regulatory framework specific to the European Union.

ISO 13485 provides the structural foundation for a medical device QMS internationally. ISO 13485 is based on the Plan-Do-Check-Act (PDCA) cycle, emphasizing risk-based decision-making, design and manufacturing control, and traceability. Other QMS requirements include management responsibility, documented procedures, CAPA, and continuous improvement.

EU MDR, in contrast, builds on ISO 13485 by incorporating region-specific legal obligations necessary for placing devices on the EU market. EU MDR includes requirements such as appointing a Person Responsible for Regulatory Compliance (PRRC) under Article 15 and implementing detailed PMS and Post-Market Clinical Follow-Up (PMCF) systems (Annex III and XIV). Other requirements include preparing clinical evaluation reports (Annex XIV) and completing conformity assessments based on device classification (Annex IX-XI). EU MDR also mandates UDI system integration, vigilance reporting, EUDAMED registration, and active oversight of economic operators (e.g., authorized representatives, importers, and distributors).

To ensure comprehensive compliance, manufacturers can integrate ISO 13485 as the backbone of their QMS while mapping its clauses to EU MDR Article 10(9) and associated annexes. Using Annex Z of EN ISO 13485, manufacturers can identify and address any regulatory gaps, thereby achieving both international quality alignment and EU market compliance. Article 10(9) of the EU MDR outlines the minimum QMS requirements in ISO 13485.

The table below maps EU MDR requirements under Article 10 General Obligations of Manufacturers to corresponding ISO 13485 clauses based on Annex ZA.1 of EN ISO 13485:2016+A11:2021.

Requirements of Article 10 of EU MDR	ISO 13485 clause(s)/sub-clause(s) that covers EU MDR requirements
1	4.1, 7.1, 7.2.1c, 7.2.2c, 7.3, 7.5 Partially covered
2	7.1 Partially covered
3	Not covered
4, 1st paragraph	4.2.3 Partially covered
4, 2nd paragraph	Not covered
5	4.2.3 Partially covered
6	Not covered
7	Not covered
8, 1st paragraph	4.2.4, 4.2.5, 7.2.3 Partially covered
8, 2nd paragraph	7.2.3 Partially covered
8, 3rd paragraph	Not covered
9, 1st paragraph, 1st sentence	4, 5, 6, 7, 8, Covered
9, 1st paragraph, 2nd sentence	4.1.4, 4.2.4, 5.6.2, 5.6.3, 7.3.3, 7.3.9 Partially covered
9, 1st paragraph, 3rd sentence	4.1 Partially covered
9, 2nd paragraph	4.5, 6, 7, 8 Covered
9, 3rd paragraph (a)	4.1.1, 7.3.9 Partially covered
9, 3rd paragraph (b)	4.2.3, 7.2.1c, 7.3.3b, 7.3.4a, 7.3.5 Partially covered
9, 3rd paragraph (c)	5 Covered
9, 4th paragraph (d)	4.15, 6, 7.4.1 Covered
9, 3rd paragraph (e)	4.1.2, 6, 7.1 Partially covered
9, 3rd paragraph (f)	Not covered
9, 3rd paragraph (g)	7.1, 7.3.2, 7.3.8, 7.5.1, 7.5.4 Covered
9, 3rd paragraph (h)	Not covered
9, 3rd paragraph (i)	8.2.1, 8.5.1 Partially covered
9, 3rd paragraph (j)	7.2.3 Partially covered
9, 3rd paragraph (k)	8.2.2, 8.2.3, 8.3.3 Partially covered
9, 3rd paragraph (l)	8.5.2, 8.5.3 Covered
9, 3rd paragraph (m)	8.2.5, 8.2.6, 8.4, 8.5 Covered
10	8.2.1, 8.5.1 Partially covered
11	4.2.3a, 7.3.3, 7.5.1e Partially covered
12	7.2.3, 8.2.2d, 8.2.3, 8.3.3 Partially covered
13	8.2.3 Partially covered
14, 1st paragraph	7.2.3 Partially covered
14, 2nd, 3rd and 4th paragraph	Not covered
15	4.1, 4.2.3, 7.2.3, 7.4
16	Not covered

How Can Medical Device eQMS Support EU MDR Compliance?

An electronic Quality Management System (eQMS) is a software-based QMS platform that helps medical device manufacturers or economic operators manage and automate quality processes.

An eQMS provides medical device manufacturers and other economic operators with structured, traceable, and auditable processes to comply with EU MDR. Unlike paper-based systems, eQMS enables real-time oversight, automates workflows to enhance efficiency and reduce errors, and provides a central repository for controlled records such as technical documents and design records.

The areas where eQMS tools facilitate compliance with the EU MDR are listed below.

• Centralized Document Management and Control: An eQMS serves as centralized, controlled document access and ensures real-time version control and electronic signatures that meet both EU Annex 11 and 21 CFR Part 11.
• Automated Workflows for CAPA, Audits, and Change Control: eQMS platforms streamline CAPA, internal audits, and change control by automating workflows to ensure traceability and full alignment with EU MDR Article 10(9) requirements.
• Integrated Risk Management and Clinical Evaluation Tracking: Risk analysis and integrated clinical evaluation tracking are digitized in eQMS tools, and directly linked to product technical documentation.
• Monitoring of PMS and vigilance: eQMS facilitates PMS, PMCF, and vigilance reporting through scheduled assignments, reminders, and easily accessible report templates.
• UDI and traceability record-keeping: eQMS stores and links UDI-DI and UDI-PI with device history records and batch releases. This data connectivity enables full traceability across the medical device lifecycle.

Overall, a medical device eQMS improves audit readiness reduces errors, enhances collaboration, increases scalability, and provides real-time access to quality and compliance data.

SimplerQMS offers an eQMS validated according to GAMP5 requirements and compliant with FDA 21 CFR Part 11 and EU GMP Annex 11. SimplerQMS supports companies in achieving compliance with QMS requirements such as EU MDR and ISO 13485 through comprehensive QMS modules equipped with automated workflows.

SimplerQMS has comprehensive capabilities such as document control, training, CAPA, risk management, supplier oversight, audit preparation, and more to facilitate EU MDR requirements efficiently.

Book a demo with our Quality Solutions Consultant today to learn how SimplerQMS can streamline EU MDR compliance, improve efficiency, and improve your company’s other QMS processes.