Article 10 of MDR

Services according to the MDR Regulation Article 10 (EU) 2017/ 745

Our team of experts have over 25 years of experience and can help you implement the applicable Quality Management System (QMS) according to Article 10 of MDR.

Services-MDR-Regulation-Article-10-EU-2017-745
Summary

A quick overview of this page

Achieving your Quality Management System

A Quality Management System (QMS) is implemented in order to help an organisation to continuously develop the quality of their products and services. Thus, it is important when building a quality system that one conforms to the requirements and guidelines set in standard MDR Article 10, especially if one plans the auditing of the quality management system. Additionally, the QMS needs to be continuously maintained, meaning its documentation must be keeping up to date.

Challenges of obtaining a Quality Management System

Obtaining a Quality Management System can be a complicated process. For this, it is important to make use of MDR Article 10 as it outlines the requirements for the QMS that all manufacturers must follow in order to be able to put their product or service into the market.  

Guidance from start to finish

Our team of experts can aid in helping you to implement the applicable QMS according to MDR Article 10 and guide you through this process.  

Who We Serve

Article 10 of the MDR

Your partner for a QMS accordingt to Article 10 of the MDR 

What is MDR Article 10?

Article 10 of the Medical Device Regulation sets forth to ensure that when manufacturers place their devices on the market or put them into services, that the product has been designed and manufactured in a way that ensures the safety of it and its user. The regulations include:

  • Processes and procedures
  • Conformity assessment route
  • Technical Documentation
  • Regulatory compliance
  • Verifying the Declaration of Conformity
  • Verification that UDI’s are properly used
  • Post market surveillance

Ensure and maintain your Quality!

The Advantages of MDR Article 10

Having a QMS system ensures that an organisation will continuously develop the quality of their products and services. Article 10 MDR is specifically advantageous as it verifies:

  • A strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system
  • Identification of applicable general safety and performance requirements and exploration of options to address those requirements
  • Responsibility of the management
  • Resource management, including selection and control of suppliers and sub-contractors
  • Risk management as set out in in Section 3 of Annex I
  • Clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF
  • Product realisation, including planning, design, development, production and service provision
  • Verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29
  • Setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83
  • Handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders
  • Processes for reporting of serious incidents and field safety corrective actions in the context of vigilance
  • Management of corrective and preventive actions and verification of their effectiveness
  • Processes for monitoring and measurement of output, data analysis and product improvement

The Roadmap for MDR Article 10

Certification Experts’ method to develop a QMS varies from client to client. In most cases our team implements the following plan:

  1. Gap analysis: The performance of your business unit is assessed to determine whether business requirements or objectives are being met and, if not, what steps should be taken to meet them. Based on the gap analysis, your company has a clear view on how much time is spent, which costs are associated with this and how much effort it will take
  2. Quality System: Set up a quality system, including all applicable procedures, work instructions, standard forms and supporting documentation according to Article 10
  3. Implementation session: Plan a meeting or workshop, including presentation, where we will discuss and plan the practical steps and strategies for complying with the requirements outlined in Article 10 of the MDR
  4. Internal audit: Checking if the QMS has been implemented well and according to the standard
  5. Maintenance: Periodically update and update the management system, so that your organisation continues to meet the requirements of the standard

Our Medical Team can also provide the following in relation to Quality Management Systems (QMS):

Also check out our options to help you certification proces for a CE mark medical device or let us answer all your questions about medical CE.

Portfolio

Check out our Article 10 MDR QMS services

Art. 10 of MDR

Our team of experts can aid in helping you to achieve the Article 10 of MDR requirements. This article outlines the requirements for the QMS that all manufacturers must follow in order to be able to put their product or service into the market. Our team of experts can aid in helping you to implement the applicable QMS according to Article 10 of MDR and guide you through this process. 

  • Gap Analysis (see what you have and what you still need)
  • Set up a quality system with all applicable procedures, work instructions, standard forms and supporting documentation according to article 10
  • Implementation session with presentation
  • Internal audit – checking if the QMS has been implemented well and according to the standard 
  • Maintenance of QMS

Internal Audit

Our team of experts can provide aid via the Testing of your management system against standards, the law and your own requirements. The internal audit is also the preparation for the certification audit.

  • Internal Audit

Management Review

Certification Experts will support the management in assessing the effective operation of the quality management system and help identify opportunities for improvement and risks.

  • Management Review

Certification Audit

Certification experts will support with certification audit. During the on-site audit our experts will provide on-site support to assist with any queries that arise during the audit. With our guidance, companies can approach the QMS certification audit with confidence, knowing that they are well-prepared and supported every step of the way.

  • Advise and support during certification audit

Non-Conformance Procedure

A Non-Conformance Procedure within a Quality Management System (QMS) is a structured and documented process that outlines the steps to be taken when a non-conformance is identified within the organization’s quality processes. A non-conformance refers to any instance where a product, process, or activity does not meet the specified requirements, standards, or expectations.

  • Identifying and documenting the non conformity (With evidence/proof in the form of photos)
  • Root Cause analysis of the con conformity (by applying the 5 way method or the Ishikawa method (fishbone)
  • Corrective and preventive actions  (CAPA’s)
  • Preventative actions which will stop the non conformance from occurring again
  • Effectiveness check on the taken actions
  • Close out signatures once both or all parties have  rectified and closed the non conformance

QMS Maintenance 

The basis of a quality management system is the continuous improvement and optimisation of the organisation. Once the certificate has been obtained, the quality must be continuously maintained. By engaging with our Medical Team, you can enhance the effectiveness of your QMS, maintain compliance with regulatory standards, and ensure the continued safety and quality of your medical devices in the market.

  • Maintenance QMS
Frequently asked questions

All the answers you might need!

Compliance with Article 10 of the Medical Device Regulation (MDR) significantly impacts the approval and certification process for medical devices. It necessitates a robust Quality Management System (QMS) integral to the conformity assessment, emphasising comprehensive technical documentation, potential involvement of Notified Bodies for QMS conformity verification, and obligations for post-market surveillance. A compliant QMS enhances regulatory confidence in the manufacturer’s ability to consistently produce safe and effective devices. The integration of risk management practices, continuous improvement, and adaptation to regulatory changes are essential components of Article 10 compliance, contributing to the overall safety and efficacy of medical devices in the market. Manufacturers should stay informed about regulatory updates to ensure ongoing compliance.

A Quality Management System (QMS) offers numerous benefits to organisations across various industries. Some of the key advantages include:

  • Enhanced Customer Satisfaction: By consistently delivering high-quality products or services, organisations can enhance customer satisfaction and loyalty.
    Improved Product or Service Quality: A QMS helps organisations identify and address issues in their processes, leading to improved product or service quality.
    Increased Efficiency and Productivity: Streamlining processes and reducing errors through a QMS can lead to increased efficiency and productivity.
    Regulatory Compliance: Implementing a QMS helps organisations comply with industry regulations and standards, reducing the risk of legal and regulatory issues.
    Risk Management: QMS includes risk management practices, allowing organisations to identify, assess, and mitigate risks, thereby minimizing potential negative impacts.
    Cost Savings: Effective quality management can lead to cost savings by reducing waste, rework, and the need for corrective actions.
  • Continuous Improvement:A QMS promotes a culture of continuous improvement, encouraging organisations to regularly review and enhance their processes.
    Employee Engagement: Involving employees in quality management processes fosters a sense of ownership and engagement, leading to improved morale and teamwork.
    Competitive Advantage: Organisations with a robust QMS often gain a competitive advantage by demonstrating their commitment to quality and customer satisfaction.
    Better Decision-Making: Access to accurate and timely information through a QMS enables informed decision-making at all levels of the organisation.
    Enhanced Supplier Relationships: A QMS helps organisations work closely with suppliers, ensuring the quality of inputs and fostering strong partnerships.
    Brand Reputation: Consistently delivering high-quality products or services contributes to a positive brand reputation and can lead to increased market share.
    Easier Audits and Certifications: Organisations with a QMS find it easier to undergo audits and obtain certifications, demonstrating compliance with industry standards.
    Traceability and Accountability: A QMS provides traceability of processes and products, enhancing accountability and facilitating root cause analysis when issues arise.
    Adaptability to Change:Organisations with a QMS are often more adaptable to changes in the business environment, allowing them to respond effectively to market demands and challenges.
  • In summary, a well-implemented Quality Management System is a strategic asset that contributes to organisational success, customer satisfaction, and sustained improvement.

Article 10 of the Medical Device Regulation (MDR) outlines key requirements regarding Quality Management Systems (QMS). Manufacturers are obligated to establish and maintain a QMS proportionate to the risk class and device type. The QMS is integral to the conformity assessment process, supporting the creation of comprehensive technical documentation. Depending on the device’s risk class, a Notified Body may be involved in assessing the QMS. The QMS should include provisions for post-market surveillance, ensuring ongoing monitoring of device performance and safety. Continuous improvement is emphasized, encouraging manufacturers to regularly assess and enhance their QMS for ongoing compliance. For precise details, refer to the latest version of the MDR and seek guidance from our regulatory experts.

Article 10 of the Medical Device Regulation (MDR) focuses on the conformity assessment of medical devices based on the implementation and assessment of a Quality Management System (QMS). Key aspects include the requirement for manufacturers to maintain a QMS, undergo conformity assessment, and provide comprehensive technical documentation. The article emphasizes the role of Notified Bodies in certain cases and underscores post-market surveillance obligations to ensure ongoing safety and performance monitoring.

A Quality Management System (QMS) is a structured set of activities and processes that an organization establishes to manage and enhance the quality of its products or services. It involves key elements such as a quality policy, objectives, documentation, process management, risk mitigation, continuous improvement, and a focus on customer satisfaction. The QMS aims to meet customer requirements consistently and can be certified based on international standards like ISO 9001, tailored to specific industries such as medical devices (ISO 13485), or automotive (ISO/TS 16949). The system involves regular audits, training, and a commitment to ongoing improvement to ensure effectiveness and compliance with established standards.

Certification Experts provides a range of QMS services tailored to the medical device industry, covering areas such as Article 10 MDR, ISO 9001, ISO 13485, and Good Distribution Practice (GDP) Quality Management Systems (QMS).

Manufacturers should take several steps to align their Quality Management Systems (QMS) with the requirements of Article 10 of the Medical Device Regulation (MDR). This includes understanding Article 10 requirements, conducting a gap analysis, updating QMS procedures and documentation, implementing risk management practices, collaborating with Notified Bodies when required, enhancing post-market surveillance processes, providing training to personnel, documenting compliance, and seeking professional guidance when needed. These steps aim to ensure that the QMS meets regulatory standards, addresses risk classifications, and is adaptable to changes in regulations and organisational needs.

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Carolina Koster Operations Manager
Your expert conducted an internal audit for ISO 13485 at our company. The pre-audit communication was clear and brought valuable expertise. Despite some challenges, your expert was understanding and fostered a relaxed atmosphere. The audit was thorough and effectively pinpointed our areas for improvement. We are grateful and will be working on the feedback.

Van Heek Medical

Wilma Peereboom Quality Coordinator
The cooperation with Certification Experts is satisfactory. They are decisive from the start and one of their main strengths is their excellent problem-solving skills.

Ensure and maintain your Quality!