Developing Audit-Ready EU MDR Technical Files
The European Union Medical Device Regulation 2017/745 (EUMDR or MDR) is a set of regulations that outline the requirements for medical devices to be placed into commercial distribution within countries of the European Union. One of the important requirements of the EUMDR is the development and maintenance of technical files for medical devices. Annex II of the EUMDR outlines the requirements for “Technical Documentation” which the medical device industry typically refers to as the “Technical File”. While Annex II specifies the overall content of the technical file, Annex I defines the General Safety and Performance Requirements (GSPRs) that are essential to the device and must be specified within the technical file. Annex III defines the requirements for maintaining technical documentation on post-market surveillance. Annexes I, II, and III collectively establish requirements for the technical file. In this piece, we’ll cover:
What is a Technical File and Why is it Needed
A technical file is a collection of documentation, records, and data that provides evidence that a specific medical device (or medical device family of products) meets the requirements of the EUMDR. It contains information about the design, manufacture, and performance of the device, as well as any clinical data or relevant research and post-market surveillance data.
Creating a technical file can be a complex process, but it is essential to ensuring that a medical device is safe and effective for use, and failure to ensure both historical and new product technical files meet the requirements of the EU MDR could put EU commercial market access at risk. Much of the content of the medical device technical file is leveraged for the development of the marketing authorization dossier which is reviewed by authorities as part of the process of approving the device for commercial distribution in the EU.
There are several points to consider when establishing or remediating legacy technical files for EU MDR compliance and readiness for audit by a Notified Body.
1) Understand the Classification of the Medical Device
Classification of devices is based on intended use, device risk, and novelty of the technology. Devices classifications are defined as Class I, IIa, Iib, or III based on the classification rules in Annex VIII of the EUMDR. Class I devices are the lowest risk, while Class IV devices are the highest risk. Knowing the classification of the device is fundamental to determining the essential requirements that must be met for EUMDR market authorization.
2) Identify the essential requirements of the EU MDR that apply to the device.
The essential requirements of the EU Medical Device Regulation (MDR) are the minimum standards that a medical device must meet in order to be placed on the EU market. These requirements are outlined in Annex I of the MDR and include General Safety and Performance Requirements. It is also important to determine which post-market requirements will apply to the device based on requirements of Annex III. as well as requirements related to clinical evaluation, post-market surveillance, and labeling.
With knowledge of the device classification, consult Annex I of the EUMDR to identify the specific essential requirements that apply to the device. This may include requirements related to design, performance, labeling, and clinical evaluation. The technical file must specifically address each of the GSPRs in Annex I.
- Chapter I of Annex I specifies general requirements to be met in relation to risk management. Most manufacturers leverage the procedures they have established to document alignment with ISO 14971, Application of Risk Management to Medical Devices, as a means to demonstrate that the EUMDR risk management requirements are met.
- Chapter II of Annex I specifies the requirement to be met relative to device design and manufacture. This includes requirements relative to the safety and biocompatibility of materials used in the devices, infection and microbial contamination controls, device construction, interaction with the environment, and radiation safety.
- Chapter III of Annex I addresses the requirements to be met for information supplied with the device. This chapter describes the requirements for labels and labeling.
The technical file must address every requirement in Annex I, II, and III. This typically means developing a document or spreadsheet that specifies the requirement, as stated in the Annex, and then provide a clear description of how this requirement is met for the device with clear reference to relevant documentation that provides evidence of this. If a requirement is not applicable to the device, the technical file cannot eliminate reference to the requirement but must state why the requirement is not applicable. It is generally not sufficient to state that the requirement is “not applicable” or “N/A”. A rationale for non-applicability must be stated.
3) Gather all the necessary information about the device, including design and development data, and production and process control information.
- Gathering all the necessary information about the medical device is an important step in the process of creating a technical file for a EUMDR-compliant device. This information will be used to demonstrate that the device meets the essential requirements of the EU MDR and is safe and effective for use. Here are some steps you can follow to gather all the necessary information about the device:
- Consult the design and manufacturing documentation for the device. This may include design requirements, specifications, manufacturing process flow diagrams, process control plans, and/or quality control plans. For devices intended for market in the US as well as the EU, this is the information that resides in the Design History File (DHF) in accordance with 21 CFR 820.30(j). The Quality Plans, and Production and Process Control plans are typically established during design transfer and as part of product realization. For devices intended to market in the US, this information may be included in the Device Master Record, per 21 CFR 820.181.
- Review the results of design verification and design validation testing that has been performed for the device. This should include, for example, functional and performance testing, biocompatibility testing, shipping studies, conformity assessment testing by a notified body, etc. Reference to the design verification and design validation protocols and reports can be used to show how the GSPRs of Annex I have been met.
- If the device is based on the technology of an existing device, meaning that the device leverages the safety, effectiveness, and performance data from a similar device, gather information about the performance and safety of that similar device. This may include data from previous design verification and validation, clinical trials, and/or post-market surveillance. The technical files will need to provide justification for the use of data from an existing device to meet the requirements for the new device. A comparison table showing similarities between the existing and current device regarding intended use, design, functionality, etc., should be included with an explanation of the differences between the two and how these differences could impact hazards or harms.
- Consult the labeling and instructions for use of the device. This will provide important information about the intended use, contraindications, and potential risks associated with the device.
It may be helpful to generate a comprehensive index of all available design, manufacturing, and labeling information for the device (if this does not already exist in the form of a Design History File Index and Device Master Record). This will document details to be referenced in building the technical file. This information, collectively, will ensure that the technical file is complete and provides a comprehensive overview of the device’s design, performance, and safety.
4) Gather clinical data and information to support device safety and usability.
Design validation will include performance testing under actual or simulated use conditions, including, design usability testing. It may also include clinical research data that supports the safety and effectiveness of the device. This may include data from clinical trials as well as literature reviews performed and summarized within the Clinical Evaluation Report (CER) if one was required and established under EUMDR Article 61 and Annex XIV.
When addressing clinical data or clinical research in the technical file:
- Start by reviewing the clinical data or research that is available for the device. This may include data from clinical trials, usability studies, or literature reviews.
- Select the clinical data or research that is most relevant to the device and its intended use. This may include data that supports the safety and effectiveness of the device, or data that demonstrates its performance in real-world settings.
- Organize and summarize the selected clinical data or research into a logical and easy-to-understand format. This may include tables, figures, or summaries of key findings.
- Include a description of the methods and procedures used to collect the clinical data or research. The inclusion and exclusion criteria for specific articles or data need to be clear. This will help reviewers understand the validity and reliability of the data.
- Provide a summary of the key findings from the clinical data or research. This should include any important conclusions or implications for the safety and effectiveness of the device. Leverage the information and conclusions provided within the Clinical Evaluation Report (CER.)
By including relevant clinical data or research in the technical file, you can help to support the safety and effectiveness of the device and provide evidence that it meets the essential requirements of the MDR.
5) Write a detailed description of the device, including its intended use, design, and performance characteristics.
Writing a detailed description of the medical device is an important part of creating a technical file for an EU MDR-compliant device. This description should provide a comprehensive overview of the device, including its intended use, design, and performance characteristics. When developing the device description:
- Start by clearly stating the intended use of the device. This should include a description of the conditions or diseases that the device is intended to diagnose, treat, or prevent.
- Provide a detailed description of the device’s design, including its physical characteristics, materials of construction, and any key components or features.
- Describe the performance characteristics of the device, including its accuracy, reliability, and any relevant performance data.
By providing a detailed description of the device, you can help reviewers understand the intended use, design, and performance of the device and ensure that it meets the essential requirements of the MDR.
6) Organize the information into a logical structure that is easy to understand and navigate.
Annex II requires that “technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organized, readily searchable and unambiguous manner.” Once you have gathered all the necessary information about the medical device, the next step is to organize this information into a logical structure that is easy to understand and navigate. This will help to ensure that the technical file is clear, concise, and organized in a way that is easy for reviewers to understand. Here are some tips for organizing the information in the technical file:
- Start by creating an outline or table of contents that provides a high-level overview of the information in the technical file. This will help reviewers quickly find the information they are looking for.
- Group similar information and use subheadings to break up long sections of text. This will make the technical file easier to read and navigate.
- Use tables, figures, and other visual aids to help illustrate important points and make complex information easier to understand.
- Include cross-references and hyperlinks to related information within the technical file. This will make it easy for reviewers to quickly find additional information on a particular topic.
- Remember that each individual and specific GSPR must be addressed in the technical file. Try to organize the information to address each GSPR in the order presented in EUMDR Annex I. Similarly, address requirements of Annex II, and III, in the order presented in the regulation. This will facilitate a future audit of the file.
By organizing the information in the technical file in a logical and easy-to-understand way, you can help reviewers quickly find the information they need and make the review process more efficient.
7) Ensure that all the information in the technical file is up-to-date and accurate.
Ensuring that the information in the technical file is up-to-date and accurate is an important part of the process of creating a technical file for an EU Medical Device Regulation (MDR) compliant medical device. This will help to ensure that the technical file is complete and provides an accurate and current overview of the device.
Points to consider in maintaining the technical file, include the following:
- Review the information in the technical file regularly. The review and maintenance of the technical file should be described in standard operating procedures.
- As changes are made to medical device labeling, design, manufacturing, and testing, concurrently update the relevant sections of the technical file. Ensure changes control procedures include requirements for review of the technical file to determine changes that may be required there, as well as a review of the risk management file, design history file, and the device master record. The technical file should reflect the current state of the device.
- Post-market surveillance may drive changes to the labeling, design, manufacture, and testing. Results of post-market surveillance should be referenced in the technical file, in accordance with Annex III and in accordance with Post Market Surveillance Plan established under EUMDR Articles 83 and 84. This includes results of post-market clinical follow-up if this is required based on the device classification.
By regularly reviewing and updating the information in the technical file, you can ensure that it is complete, accurate, and up to date. This will help to ensure that the device is compliant with the EU MDR and ready for routine Notified Body audit.
Creating a technical file for a medical device is an important part of the EUMDR compliance process. It provides evidence that the device meets the essential requirements of the regulation and is safe and effective for use. Having a well-organized and up-to-date technical file will contribute to successfully notified body inspections and support continued access to the EU market.