Newsletter No 42 February 2024

Subject: Data analysis in the context of MDR

As introduced in November’s newsletter, 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.

In past editions we have treated the processes of monitoring, measurement and improvement. In this newsletter edition, we are taking a closer look at how manufacturers fulfil their obligations on data analysis.

Which is the purpose of data analysis?

The purpose is to determine, collect and analyze appropriate data to demonstrate the suitability, adequacy and effectiveness of the quality management system.

How is data analysis managed?

The manufacturers of medical devices have processes in place for data analysis that include determination of appropriate methods, including statistical techniques and the extent of their use. The data used for the analysis is obtained from the processes of monitoring and measurement.

Data analysts work with large amounts of data: facts, figures and numerical calculations. Requirements for adequate analysis are as follows:

  • Communication Skills: to present the results of the analysis into an understandable document and in upper management meetings.
  • Critical Thinking: to look at the numbers, trends and data and come to new conclusions based on the findings.
  • Attention to Detail: Data is precise. Data analysts must make sure they are vigilant in their analysis to come to correct conclusions.
  • Math Skills: to estimate numerical data.

The analysis of data must include data generated as output of monitoring and measurement and from other relevant sources and include, at a minimum, input from:

  • Feedback
  • Conformity to product requirements
  • Characteristics and trends of processes and product, including opportunities for improvement
  • Suppliers
  • Audits
  • Service reports, as appropriate

Data obtained from the processes is analyzed by statistical and non-statistical techniques.

Examples of statistical techniques are:

  • Statistical Process Control (SPC) charts
  • Pareto analysis
  • Data trending
  • Graphical methods (histograms, scatter plots, etc.)

Examples of non-statistical techniques are:

  • Management reviews
  • Results from quality meetings
  • Failure Mode and Effect Analysis (FMEA) that is part of the risk management process

If the analysis of data shows that the quality management system is not suitable, adequate or effective, the organization shall use this analysis as input for improvement. Examples of improvement actions are CAPA initiation, reassessment of resources, among others.

Records of the results of analysis are maintained and used to document rationales for recommendations and/or decisions on whether or not to initiate further actions.

Which is the role of the distributors?

While data analysis is the responsibility of the manufacturer, distributors play a necessary role in providing information on product performance on the market including customer feedback, complaints and suspected vigilance or recall events. As a result, the more data the manufacturer has for analysis, the faster it will be possible to detect potential problems and initiate improvement actions.

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 sets 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 March. We wish everyone a pleasant month.

Augusto Orsini
CEO STS Medical Group

Meritxell Laguna
Group Manager Regulatory Affairs
STS Medical Group