Introduction to MDR QMS Requirements
A complete and comprehensive understanding of the EU MDR QMS requirements is becoming essential for an effective implementation of the New European Medical Device Regulations. We all know how a soldi Quality Management System is required to ensure the quality, safety and efficacy of the devices on the market. An efficient Quality Management System compliant with EU MDR 2017/745 is a mandatory requirements to obtain CE marking for medical devices.
The requirements for the Quality management System in the framework of the EU Medical device Regulations are mentioned in the Article 10 of the regulation. This article explains the general obligations that manufacturers shall fulfil in order to have the capacity to obtain CE marking and place the device on the market. Within the general obligations listed in Article 10 of EU MDR, there is the requirement to implement and maintain a Quality Management System that is able to address specific aspects to ensure quality and safety of the devices.
Deep Dive into MDR QMS Requirements
Let’s have a look to the EU MDR QMS Requirements mentioned in the Article 10.
First of all, the QMS shall cover “a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system”. Basically, the manufacturers shall select and respect the requirements associated to the conformity assessment chosen for the specific product. Moreover, specific attention shall be given to change management and the notification to the notified body in case of substantial changes to product or to Quality Management System.
The second EU MDR QMS requirement mentioned in the Article 10 is related to the so-called GSPR – General Safety and Performance Requirements. It is necessary to identify all the applicable GSPR and ensure to find the way to fulfil all the applicable requirements.
Subsequently, responsibility for management shall be addressed within the Quality Management System of the manufacturer. For an in depth overview of the responsibility of the top management, it is possible to refer to the dedicated section of the ISO 13485 : 2016.
Another essential EU MDR QMS requirement is linked to the management of the resources and the control of suppliers. The management of resources shall be intended not only as human resources, but also in terms of infrastructures, equipment and work environment. Regarding human resources, it is necessary to connect with the section 6.2 of ISO 13485, where the requirements related to training, competencies, education and risk-based approach for effectiveness evaluation of training process.
Supplier management also plays a fundamental role in the Quality System of an organization. A risk-based approach for the control of the suppliers shall be implemented. The next EU MDR QMS requirement is related to risk management, which became an essential tool in the framework of Design and Development of new medical device but also within the Quality System (Risk-Based approach for QMS processes).
Clinical evaluation, including post-market clinical follow-up, is also another fundamental requirement needed for the process of CE marking. All the clinical evaluation requirements are described in the Article 61 of EU Medical Device Regulation and with ISO 14155 : 2020.
Another requirement associated to the Quality Management System and surely linked with the EU MDR 2017/745 is the one related to product realization, including planning, design, development, production and service provision. In other words, this means the necessity to document the design history file of the device and all the activities related to manufacturing operations.
Labelling requirements and, in particular, management of Unique Device identification, have also been included in the Article 10. Implementation of UDI has different due dates depending of the class of risk of the device and it is also highly linked with the Eudamed database and with other labelling requirements associated to the new ISO 20417 and ISO 15223 (version 2021).
Another important parts of the Quality System which is surely linked with the CE marking and EU MDR 2017/745 is the post-market surveillance process. It is not a something new if say that the EU MDR requires a high level of connection between design – post market surveillance – clinical evaluation – risk management. We are mainly talking of all the requirements mentioned in Article 83 of the EU MDR 2017/745, including post-market clinical follow-up and periodic safety update report.
The management of communication with competent authorities, notified bodies and economic operators shall also be handled in the framework of a Quality System. This requirement is in part connected with post-market surveillance and definitely linked with the requirements of having an efficient vigilance system in order to communicate adverse events to competent authorities and other notified body.
Finally, the last two requirements are related to the necessity to have a CAPA process up and running and a process for the measurement of the efficiency of the quality management system or, as described in the EU MDR 2017/745, “processes for monitoring and measurement of output, data analysis and product improvement”.
Conclusions
In conclusion, we have been going through the Article 10 of the EU MDR 2017/745 where the requirements associated to the Quality Management System are included. The vast majority of these requirements are covered by ISO 13485, thus companies which are already certified will have an easier approach in the establishment of a Quality System which is needed to the CE marking process.
