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.

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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 obtain your QMS certification 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):

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New Compliance

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!