Newsletter No 39 November 2023

Subject: Monitoring and measurement in the context of the MDR

Regulation (EU) 2017/745 on medical devices (MDR) establishes general obligations of manufacturers with respect to the quality management system (QMS). On article 10.9(m), special mention is made to the manufacturer’s obligation to have in place processes for monitoring and measurement of output, data analysis and product improvement.

In the same line, EN ISO 13485:2016 standard entitled Medical Devices – Quality management systems – Requirements for regulatory purposes, has a full section (section 8) dedicated to measurement, analysis, and improvement.

Why does the manufacturer need to plan and implement these processes?

  • To demonstrate conformity of product
  • To ensure conformity of the QMS
  • To maintain the effectiveness of the QMS

Each process shall include appropriate methods to collect, record, analyze data including statistical techniques, draw conclusions, communicate effectively internally and externally to stakeholders such as authorities, customers, suppliers, and finally improve processes in a proportionate manner.

In this newsletter edition, we are taking a closer look at how manufacturers fulfil their obligations on monitoring and measurement:

  • Feedback

The manufacturer shall gather and monitor information on whether the organization has met customer requirements. The information collected includes, among other information, data on post marketing surveillance or usability.

The feedback information collected serves as potential input into risk management as well as the product realization or improvement processes.

  • Complaint handling

The manufacturer shall process the complaints in a timely manner according to regulatory requirements.

The process includes receiving and recording information, assessment and investigation, regulatory reporting determination and processing, handling of complaint-related product, and determining the need to initiate eventual corrections or corrective actions,

If an investigation determines that activities outside the manufacturer contributed to the complaint, relevant information shall be exchanged between the manufacturer and the external party involved.

  • Reporting to regulatory authorities

The manufacturer shall notify the appropriate regulatory authorities in a timely manner of any events that meet reporting criteria, such as serious incidents, trends, field safety corrective actions.

In the same direction, the manufacturer shall notify any significant change in scope of device certification to the Notified Body and await approval prior to implementation.

  • Internal audits

The manufacturer shall conduct internal audits at planned intervals to determine whether the QMS conforms to the external regulatory and company requirements, and is effectively implemented and maintained. The auditors need to be objective, impartial and appropriately trained.

All necessary corrections and corrective actions shall be taken without undue delay. Follow-up activities shall then include the verification of the actions and reporting of verification results.

  • Monitoring and measurement of the QMS processes

The manufacturer shall apply suitable methods for monitoring and, as appropriate, measurement of the QMS processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, the manufacturer shall take corrections and corrective actions as appropriate.

  • Monitoring and measurement of product

The manufacturer shall monitor and measure the characteristics of the product to verify that product requirements have been met. This is carried out at different stages of the product realization, depending on the internal procedures on quality control, calibrations and validation.

Batch release records shall keep evidence of conformity to the acceptance criteria.

Which is the role of the distributors?

Distributors, due to their unique position in the distribution chain closer to the end user of the product, receive valuable information on the performance of the product in the market. Therefore, distributors play a crucial role in communicating this information to the manufacturer in the form of feedback, complaints or forwarding of local competent authority notifications.

Timely and accurate communication between the manufacturer and the distributor allows an early inclusion of the data in the manufacturer’s QMS, resulting in better monitoring and measurement results and better QMS performance.

This newsletter is part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the MDR Art.22 “Systems and Procedure Packs”. 

We are already today all dependent on efficient cooperation. For the MDR implementation, we require even closer collaboration to ensure we all can deliver safe supplies to hospitals and patients in the future.

We are confident we will continue to supply health care competently on customized surgical procedure packs and small kits.

Do you wish to know more about specific MDR topics? Do you have any questions or comments about STS newsletter? Write us at

The next MDR newsletter will be issued in December. We wish everyone a pleasant month.

Augusto Orsini
CEO STS Medical Group

Meritxell Laguna
Group Manager Regulatory Affairs
STS Medical Group