Quality Management Systems (QMS) in the MDR

A detailed guide and analysis on how to ensure your Quality Management System (QMS) is ready for the EU Medical Device Regulation.

What are Quality Management Systems?

The MDR defines Quality Management Systems (QMS) as formalised systems that document processes, responsibilities and procedures to ensure and continuously improve the standard of business activities.

By establishing and implementing a QMS, an organisation defines a standardised set of processes for each business activity. In this way, a QMS ensures that tasks are completed to a specified standard and that individuals within the organisation have a clearly defined set of roles and responsibilities for upholding and maintaining product quality.

What are the MDR requirements for Quality Management Systems?

Quality Management System process for the EU MDR

Article 10 MDR outlines a list of requirements for Quality Management Systems for Manufacturers within the medical device industry. Article 10 requires that manufacturers establish, document, implement, maintain, keep up to date and continually improve a quality management system that conforms to MDR standards. It also requires that the QMS is proportionate to the risk class and to the type of device.

Article 10 calls for manufacturers to have a QMS that covers “…all parts and elements…” of their organisation, addressing the quality of processes and procedures as well as that of the medical devices themselves.

Article 10 sets out a number of essential aspects that the QMS must address at a minimum. These include:

  • a strategy for regulatory compliance
  • a process to enable identification of all Annex I General Safety and Performance Requirements (GSPRs) that apply to each product, and how they will be addressed responsibilities of company management in running the company, ensuring quality standards are upheld, and ensuring maintenance, implementation and upkeep of the QMS
  • a process for managing resources, including managing sub-contractors and suppliers
  • a Risk Management procedure
  • a procedure for performing Clinical Evaluation
  • a product realisation process, extending from product conceptualisation through development to production and service provision
  • a procedure for ensuring UDI standards are upheld setting up and running a Post-Market Surveillance (PMS) system for each product
  • a procedure for handling communications with competent authorities and Notified Bodies
  • a Vigilance system procedure
  • a process for measuring and acting upon data relating to product performance and the need for product improvement.

It can be seen from this list of minimum requirements that the Quality Management System requires a documented process for all of the major activities that relate directly to individual medical devices, as well as more general processes relating to the functions of the company as a whole.

How to design and implement an MDR QMS

It can be seen from MDR Article 10 that MDR QMS requirements are very extensive and call for a well-constructed and robust system. To assist manufacturers in implementing MDR requirements such as quality management systems, the MDR allows for the use of harmonised standards such as ISO standards to guide design and implementation. Adherence to a recognised harmonised standard will lead to a rebuttable presumption of conformity with those aspects of the MDR to which that harmonised standard relates.

The harmonised standard that applies to Quality Management Systems is ISO 13485:2016 - “Quality Management for Medical Devices”. ISO 13485 details a wide range of provisions for building QMSs that cover the majority of requirements relating to quality management in the MDR.

It should be noted that while ISO 13485:2016 is extensive, it was developed in reference to the out-going Medical Device Directive MDD 93/42/EC rather than the MDR. While it addresses most of the requirements for QMS in the MDR there are some areas that ISO 13485 does not cover in enough detail to ensure MDR compliance. These areas include:

  • Requirements for documentation to be produced for each product. The extra requirements imposed by MDR can be found in Annex II - Technical Documentation
  • Additional requirements for documents relating specifically to PMS systems, found in MDR Annex III - Technical Documentation for PMS
  • Requirements for documented processes relating to Clinical Evaluation

How will a QMS be assessed under the MDR?

A manufacturer’s quality management system will be assessed as a component of conformity assessment procedures specified in MDR Annex IX to XI. For all except Class I devices, conformity assessment will be performed by a Notified Body.

It should be noted that Article 10 MDR requires manufacturers of all medical devices other than investigational devices to develop a QMS to the specified standard, including manufacturers of Class I devices. Although formal assessment of a QMS developed in relation to a Class I device will be less rigorous than for other device risk classes, an adequate QMS will still be required for a manufacturer to be in a position to issue a declaration of conformity and self-certify MDR Compliance.

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We have compiled some of our frequently asked questions. If you'd like to know anything else about what we do, feel free to ask us a question.

  1. We can work with the majority of medical device manufacturers seeking compliance of their devices in accordance with Medical Device Regulation (EU) 2017/745, including both hardware and software devices. We also offer a free, no-obligation consultation, so please feel confident about discussing your requirements with a member of our team.

  2. No. We will work with you to produce systems and to support your EU MDR compliance, but we do not conduct research ourselves. We will provide tools for you to conduct your own Post-Market Surveillance. Our range of services are designed to assist you in this matter.

  3. Yes. We adhere to the highest standards of professionalism and regard maintaining confidentiality and data security as a cornerstone of our practice. We also comply fully with the requirements of GDPR.

  4. Our medical device regulatory consulting is built around a strict quality framework and we only work with clients who share this commitment to quality. Our CEO is a medical doctor with years of experience in the medical device industry and assumes personal responsibility for every project. Our product development process integrates client feedback throughout product production, ensuring a constant focus on your needs.

  5. We work with clients of all sizes and at all stages of their regulatory compliance journey. Our team are here to help and are happy to respond to general enquiries, even if you don't feel like you know where to start. We are experts at 'tuning in' to your requirements and will guide you through the entire process. Our free MDR Compliance Guide and suite of MDR downloads stand as proof of our commitment to help you understand your obligations under the MDR.

  6. Yes. Software as a Medical Device is an increasingly-important segment of the medical device market. We have extensive experience in building regulatory systems for medical software and offer a special application of all our MDR services for software products. We also offer unique downloads and white papers that focus specifically on Software as a Medical Device.

  7. At its core, working with the MDR is about working with clinical evidence. Whether you need to generate evidence for PMCF, analyse data for writing a CER, or build an MDR-ready PMS system, our medical experts have the clinical acumen to ensure that your clinical evidence is produced and interpreted with the highest levels of professionalism. Medical professionals work with clinical evidence all day. We bring their specialist capabilities directly to your MDR strategy.

  8. We believe in transparency and aim to build long-term relationships with our clients. This commitment is demonstrated by our customer-focused pricing strategy. You pay a small deposit upfront, only paying the balance when the work has been completed to your total satisfaction. For higher-value projects we offer flexible payment packages on an individual basis — please contact a member of our team to find out more.

  9. Yes. Our unique business model allows us to scale to accommodate almost any amount of work. Many of our medical professionals remain clinically active, meaning that we have trained more than we presently need. This system allows us to have ready availability of redundant capacity that can be called upon in the event of a surge in demand. Whatever your requirements, our unique business model allows us to step in faster than any of our competitors.

  10. Yes. We run a number of events throughout the year focusing on specific aspects of MDR compliance. We also offer a limited number of free webinars on a limited basis — subscribe to our newsletter to be notified early when we publish new events. Of course, we also have our extensive MDR Compliance Guide and free MDR downloads suite, both of which offer extensive training on all aspects of MDR compliance.

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