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Annexes II and III of the MDR: How to Create a Technical File to Obtain CE Marking for Your Medical Devices

Medical devices regulation

1. Importance of the Technical File

Since the entry into force of Regulation (EU) 2017/745 (MDR) on medical devices, the regulatory framework surrounding the placing of medical devices on the European market has become more demanding. The MDR requires manufacturers to prove the conformity of their devices through a rigorous technical file, as described in Annexes II and III of the regulation.


For many manufacturers, the recurring question is: “How do I create a compliant technical file?” Although these documents are essential for obtaining CE marking and accessing the European market, the complexity of regulatory requirements can be intimidating, especially for companies that do not have dedicated in-house regulatory expertise.


This article aims to demystify Annexes II and III of the MDR by clearly explaining the contents of a technical file, its role in the CE certification process, and how to structure and gather the necessary elements to ensure compliance of your medical devices. You will also discover practical steps to create a solid technical file and avoid common mistakes.


The goal here is to lay the foundation of the article by contextualizing the importance of the technical file, identifying the challenges faced by manufacturers, and providing a clear overview of the article’s utility to help them navigate the requirements.



2. What is a Technical File According to the MDR?


Definition of the Technical File

The technical file is a fundamental regulatory document required by Regulation (EU) 2017/745 on medical devices (MDR). It serves to demonstrate that your medical device complies with the legal and technical requirements in force in the European Union. This document is particularly governed by Annexes II and III of the MDR, which detail the information to be provided to ensure the safety, quality, and performance of the medical device before it is placed on the European market.


The technical file is not only a regulatory requirement; it also plays a central role in CE marking, which is essential for the commercialization of medical devices in the European Union.


Why is a technical file necessary?

A technical file is required to prove that your device complies with the general safety and performance requirements (Annex I of the MDR). It must contain comprehensive technical information to allow notified bodies to validate that the medical device meets all necessary standards and requirements.


Without a complete and compliant technical file:

  • You will not be able to obtain CE marking.
  • Your device will not be authorized for sale on the European market.
  • Your company will be exposed to non-compliance risks and potential sanctions.


What does a technical file contain?

The MDR requires the technical file to be comprehensive and well-structured. Here is an overview of the main elements expected in this document, as outlined in Annex II:

1. Medical device description:

  • Type of device, variations, and accessories.
  • Device category according to risk classification (Class I, IIa, IIb, III).
  • Intended use and clinical purpose of the device.

2. Design and manufacturing:

  • Detailed information about the design of the device.
  • Materials used for each component.
  • Manufacturing process with complete traceability.

3. Safety and performance evaluation:

  • Demonstration of compliance with general safety and performance requirements (Annex I).
  • Tests and trials performed on the product (e.g., biocompatibility, mechanical resistance, etc.).

4. Clinical evaluation:

  • Clinical data proving the device’s safety and effectiveness.
  • Results of clinical studies or trials (where required for Class IIb or III devices).

5. Risk management:

  • Complete analysis of the risks associated with the use of the device (in line with ISO 14971).
  • Risk mitigation and control measures.

6. Information provided:

  • Labeling and instructions for use of the medical device.
  • Detailed instructions for use and information for users and patients.

7. Post-market surveillance (Annex III):

  • Post-Market Surveillance (PMS) plan.
  • Strategy for tracking incidents and implementing corrective or preventive actions.


Specific requirements according to the type of device

The exact content of the technical file may vary depending on the risk classification of the medical device. Class I devices, for example, generally require less documentation than a Class III implantable device. However, all devices, regardless of their risk, must be supported by solid scientific and technical evidence.



How to structure an effective technical file?

To ensure that your technical file is accepted by notified bodies, it is essential to:

  • Clearly organize each section with well-defined subtitles for each requirement.
  • Thoroughly document each step of the device’s development and manufacturing process.
  • Maintain full traceability of all changes made to the device since its design.


The importance of a well-structured technical file

A complete and well-structured technical file not only ensures your compliance with the MDR but also protects your business in the event of audits or inspections. It also demonstrates that you have mastered the critical aspects related to the safety, performance, and quality of your medical devices.



The technical file is a key element for obtaining CE marking for your medical devices. In accordance with Annexes II and III of the MDR, it allows you to prove the safety, effectiveness, and quality of your products. A poorly written or incomplete file can significantly delay market access for your product. Therefore, it is essential to give it careful attention and enlist the right expertise to draft and maintain it properly.




3. Structure of the Technical File (Annex II)


Annex II of the MDR (2017/745) defines the required elements for a technical file supporting the compliance of a medical device. This section details how to structure this file to fully meet regulatory requirements while allowing manufacturers to organize information coherently.


A complete technical file must enable a notified body or competent authority to understand the technical characteristics, manufacturing process, and safety measures implemented by the manufacturer to ensure compliance with European standards.



Key elements of the technical file according to Annex II:


3.1. General description of the device

The first part of the technical file must provide an overview of the medical device. This includes:

  • Device name and identification (product reference, model, etc.).
  • Risk category: Class I, IIa, IIb, or III.
  • Intended use of the device: Intended use, target patient population, and clinical context.
  • Description of variants and associated accessories, if applicable.


3.2. Design and manufacturing

This section concerns the full traceability of the device’s design and manufacturing process:

  • Technical drawings: Provide detailed drawings of the device and critical components.
  • Materials used: Documentation of the materials used for each part of the device, particularly for implantable devices or those in direct contact with the body.
  • Manufacturing process: Detail each step of the manufacturing process, including quality control procedures integrated into production.


3.3. General safety and performance requirements

This part is essential for demonstrating compliance with the general safety and performance requirements in Annex I of the MDR. Here’s what should be included:

  • Claimed standards and technical specifications used to evaluate the device.
  • Tests and validations: Describe the tests carried out (biocompatibility, mechanical resistance, clinical trials, etc.) to prove the device’s safety and performance.
  • Risk management: Present a complete risk analysis (in accordance with ISO 14971), with measures taken to minimize and control risks.


3.4. Clinical evaluation

The clinical evaluation is crucial for proving the safety and effectiveness of the device in real-world use:

  • Clinical data: Collect and analyze existing clinical data on the device or, if necessary, conduct new clinical investigations.
  • Clinical equivalence: If the device is similar to another already marketed device, provide evidence demonstrating equivalence (comparable device and similar clinical context).


3.5. Risk management

This section should contain the complete documentation of risk management, a key element for MDR compliance:

  • Risk analysis: Identify potential hazards associated with the use of the device.
  • Risk assessment: Assess the severity and probability of each risk.
  • Mitigation measures: Explain how these risks have been reduced to an acceptable minimum, in line with ISO 14971.

To further explore the topic of risk management, you can consult our article Understanding the Importance of the Risk Management Plan (RMP) in Medical Devices.



3.6. Labeling and information provided

The labeling and instructions for use must comply with the requirements set out in Annex I of the MDR:

  • Clear and complete labeling: All information on the label must be understandable and indelible, with traceability (CE marking, batch number, expiration date, etc.).
  • Instructions for use: Provide precise instructions to ensure the device’s safe and effective use.


3.7. Post-market surveillance (Annex III)

Although detailed in Annex III, a brief mention of the need to maintain a post-market surveillance (PMS) system is indispensable in the technical file:

  • PMS plan: Outline actions to monitor the device’s performance after it has been placed on the market.
  • Incident monitoring: Define procedures for reporting incidents and corrective actions in the event of non-compliance.


Why is structuring crucial?

Carefully organizing your technical file is essential to ensure that your device is quickly evaluated and approved by the competent authorities. A clear presentation, with well-defined subsections, will facilitate the review by notified bodies while demonstrating mastery of internal quality processes.



A technical file compliant with Annex II of the MDR is fundamental for obtaining CE marking and ensuring the regulatory compliance of your medical devices. Each section must be precisely documented to demonstrate that the device meets the safety, performance, and risk management requirements imposed by European regulations.




4. Supplementary Documentation (Annex III)


Annex III of Regulation (EU) 2017/745 (MDR) complements Annex II by focusing on the requirements related to post-market surveillance (PMS) and vigilance. This additional documentation is crucial to ensure the continuous compliance of the medical device once it is placed on the market. Manufacturers must demonstrate their ability to effectively monitor and manage the device’s performance after commercialization, quickly identify risks, and take corrective measures if necessary.



4.1. Post-market surveillance (PMS)

Post-market surveillance (PMS) is a proactive system that allows for the collection and analysis of data on the performance of a medical device after it has been placed on the market. This information helps assess whether the device continues to meet the defined safety and performance requirements.


Key elements of PMS include:

  • Systematic data collection: The manufacturer must implement an ongoing process for collecting data from real-world use.
  • Continuous risk assessment: Risks associated with the device must be reassessed in light of new data.
  • Technical file updates: PMS results should allow for revisions and improvements to the initial technical file to reflect the device’s actual performance.


4.2. Post-Market Surveillance Plan: What It Must Include

In accordance with Annex III, each manufacturer must establish a PMS plan for their device. This plan must cover several essential aspects, including:

  • Description of methods and processes used to collect, analyze, and interpret post-market data.
  • Performance and safety indicators: Define the criteria that will be used to evaluate the clinical performance of the device.
  • Risk management action plan: Explain the corrective or preventive measures planned if issues or incidents occur.
  • Trend analysis: Set up a method to detect emerging trends, such as an increase in minor incidents that could signal a more serious risk.


4.3. Vigilance: Responding to Serious Incidents

Vigilance is an integral part of the PMS system and involves the monitoring of incidents related to the use of a device. This documentation is crucial to protect users and ensure that corrective actions are taken quickly in case of problems. Annex III requires the following:

  • Detection of serious incidents: Any incident resulting in death, serious deterioration in health, or a serious public health risk must be reported promptly to the competent authorities.
  • Reporting and corrective measures: Manufacturers must have procedures in place to report these incidents and implement safety corrective actions, such as recalls or modifications to the device.


4.4. PSUR (Periodic Safety Update Report) and PMSR (Post-Market Surveillance Report)

As part of post-market surveillance (PMS), medical device manufacturers must produce regular reports to demonstrate the continuous safety and compliance of their devices on the market. The MDR (2017/745) requires two types of reports: the PMSR (Post-Market Surveillance Report) and the PSUR (Periodic Safety Update Report). These reports differ according to the risk class of the device.


PMSR (Post-Market Surveillance Report)

The PMSR is required for Class I medical devices (low-risk). It is a post-market surveillance report that contains information about the results of post-market surveillance. The PMSR must include:

  • Data collected after the device has been placed on the market.
  • Corrective or preventive actions implemented.
  • Conclusions regarding the safety and performance of the device.

Unlike the PSUR, this report does not need to be submitted to the competent authorities or notified bodies but must be available upon request.



PSUR (Periodic Safety Update Report)

The PSUR is mandatory for Class IIa, IIb, and III medical devices, as well as for implantable devices. It is a periodic safety update report that goes beyond the PMSR. The PSUR must be written at least annually for Class III and implantable devices, and every two years for Class IIa and IIb devices. The report must include:

  • Results of post-market surveillance and trend evaluation.
  • Continuous benefit/risk evaluation of the device based on new data collected post-market.
  • Conclusions on safety and performance.
  • Corrective or preventive actions implemented or planned.
  • Conclusions from Post-Market Clinical Follow-up (PMCF), if applicable.

The PSUR must be submitted to the notified body for Class III and implantable devices and made available to competent authorities for Class IIa and IIb devices. The notified body will review the PSUR to ensure that the safety and compliance of the device are maintained.



4.5. Continuous Updating of the Technical File

Annex III also emphasizes the importance of regularly updating the technical file based on information gathered through PMS. In other words, manufacturers must:

  • Incorporate new data into the technical file.
  • Revise relevant sections (risk management, clinical performance, etc.) if PMS results show significant changes in the safety or effectiveness of the device.
  • Collaborate with notified bodies if changes to the CE marking or certifications are required due to PMS results.



5. Steps to Create a Technical File Compliant with the MDR

Now that we have explored the key elements of a technical file according to Annexes II and III of the MDR, it is essential to understand how to effectively structure and develop this file. In this section, we will detail practical steps to build a complete and compliant technical file under MDR 2017/745, considering regulatory, technical, and best practice aspects.


5.1. Identify the Applicable Requirements

The first step in creating a technical file is to identify the specific requirements that apply to your medical device. This includes:

  • Classifying the device according to its risk category (Class I, IIa, IIb, III). See also our article on Medical Device Classification.
  • Identifying the applicable standards or other relevant specifications.
  • Consulting the MDR annexes to understand which sections apply depending on the nature of the device (e.g., implantable devices, single-use devices, etc.).


5.2. Gather the Necessary Technical Data

Once the requirements are identified, it is important to gather all the necessary technical information to demonstrate the compliance of your device. This includes:

  • Detailed description of the product: Technical characteristics, design, materials used.
  • Safety data: Biocompatibility tests, performance tests, and other specific tests required for the device’s classification.
  • Results of clinical evaluation: Evidence of the device’s safety and clinical effectiveness, either through studies or by demonstrating equivalence with other devices already on the market.


5.3. Structure the Technical File

A well-structured technical file not only facilitates the review by notified bodies but also ensures clarity in the presentation of information. Here are the major sections to include:

  • Device summary: General presentation of the product and its variants.
  • Design file: Complete documentation of the device’s design, materials, and manufacturing process.
  • Risk evaluation: Risk analysis and mitigation measures taken (in line with ISO 14971).
  • Clinical and preclinical data: Documentation of clinical studies, laboratory tests, and safety evidence.
  • Labeling and user documentation: Provide all relevant information on labeling, instructions for use, and user guidance.
  • Post-market surveillance: Incorporate a PMS plan as indicated in Annex III.


5.4. Validate and Approve the Technical File

Once the technical file has been drafted, it must be reviewed and validated to ensure that all information is complete and compliant. This includes:

  • Internal review by quality and regulatory teams: Ensure that all sections have been addressed and that the file is compliant with Annex II.
  • Submission to the notified body: If the device is Class IIa, IIb, or III, the file must be submitted for evaluation by a notified body before CE marking can be granted. For Class Is or Im devices, only the sterility or measurement aspect will be reviewed by the notified body.


5.5. Ensure Continuous Compliance

A technical file is not a static document. It must be updated regularly based on the results of post-market surveillance (PMS) and market feedback. Here are the key steps to maintaining compliance:

  • Update the technical file with the results of new studies or post-market use feedback.
  • Reassess risks: Every time incidents or emerging trends are detected, the technical file and risk analysis must be updated.
  • Maintain complete traceability of all modifications made to the device or its use.


5.6. Common Mistakes to Avoid

It is essential to be aware of common errors to avoid delays or rejections of your technical file. Here are the most frequent pitfalls:

  • Insufficient clinical data: The absence of solid clinical evidence can lead to rejection.
  • Incomplete risk management: Risk analysis not conforming to ISO 14971 is one of the main causes of refusal.
  • Inadequate user documentation: Poorly written or incomplete instructions for use can compromise the safety of the device.

To dive deeper into this topic, see our article titled Technical Documentation under MDR: Avoid Common Mistakes and Follow Best Practices.



Creating a technical file that complies with the MDR requires rigor and organization. Each step, from gathering technical data to validation by the notified body, must be carefully planned and executed. By following these steps, you maximize your chances of obtaining CE marking quickly while ensuring that your medical device meets the highest safety and performance standards.




6. Common Mistakes in Creating the Technical File


Creating a technical file compliant with Regulation (EU) 2017/745 (MDR) can be a complex process. Even if you follow all the steps outlined above, certain common mistakes can compromise the validation of the file or delay the issuance of the CE marking. In this section, we will highlight the common pitfalls and how to avoid them to ensure the compliance of your medical devices.



6.1. Insufficient or Inadequate Clinical Data

Problem:

The clinical evaluation is a fundamental element of the technical file. However, many manufacturers do not provide enough clinical evidence or attempt to rely on equivalence data from similar devices without proper demonstration.


Why is this a problem?

The MDR requires that clinical data be complete and appropriate for the device in question, especially for Class IIa, IIb, and III devices. Insufficient data may result in the file being rejected by the notified body.


Solution:

Make sure to conduct or document robust clinical studies and clearly demonstrate equivalence with other devices if applicable. Use trial reports, scientific publications, and field experience feedback to support this section.



6.2. Incomplete Risk Management Documentation

Problem:

Many manufacturers underestimate the scope of risk management. Failing to include a sufficiently detailed risk analysis or not complying with ISO 14971 is a common mistake.


Why is this a problem?

Risk management is at the heart of MDR compliance. If this part of the file is deemed insufficient, it can delay the issuance of CE marking and potentially compromise patient safety.


Solution:

Ensure that you carry out a complete risk analysis covering every stage of the device’s lifecycle. Risk management should be well documented and regularly updated, especially in light of post-market surveillance data.



6.3. Incomplete or Non-Compliant User Documentation

Problem:

Some companies overlook the importance of labeling and instructions for use. This may involve providing insufficient or poorly presented information regarding the use of the device, a key factor for non-compliance.


Why is this a problem?

Labeling and instructions for use are essential for the safe and proper use of the medical device. Errors in this section can lead to incorrect use of the device and pose risks to patients or users.


Solution:

Conduct usability studies in accordance with IEC 62366. Write clear, understandable instructions that comply with MDR requirements. Ensure that all safety information, instructions, and warnings are present and easy to understand.



6.4. Neglecting Post-Market Surveillance

Problem:

Post-market surveillance (PMS) is often underestimated or poorly planned. Many manufacturers do not implement an effective PMS system, failing to collect enough data after the device has been placed on the market.


Why is this a problem?

The MDR requires active and continuous surveillance once the device is commercialized. Without a well-structured PMS plan, manufacturers may fail to detect safety or performance issues, leading to product recalls or penalties.


Solution:

Implement a detailed PMS plan in line with Annex III of the MDR, including the systematic collection of user feedback, incident analysis, and regular updates to the technical file.



6.5. Missing or Outdated Technical Data

Problem:

Some companies submit technical files with missing or outdated technical data, especially regarding materials or manufacturing processes.


Why is this a problem?

Outdated or incomplete technical data may lead to a misunderstanding of the device’s characteristics by the notified body, compromising CE marking.


Solution:

Ensure that the technical documentation is up to date with current data on materials, tests, and device performance. Each modification must be documented in the technical file.



Avoiding these common mistakes in creating the technical file is essential to ensure a swift validation and avoid delays in obtaining CE marking. A rigorous approach, complete documentation, and proactive risk and post-market surveillance management are essential to meet MDR requirements and ensure the safety of medical devices.




7. Conclusion: The Importance of a Well-Structured Technical File for MDR Compliance


Creating a technical file compliant with Regulation (EU) 2017/745 (MDR) is a rigorous process, but it is essential for obtaining CE marking and ensuring the placement of your medical devices on the market in full compliance. This document plays a key role in demonstrating that your device meets general safety and performance requirements and is safe and effective for users.


Throughout this article, we have explored the essential elements that must be included in your technical file according to Annexes II and III of the MDR, and we have detailed the practical steps for its creation. We also identified common mistakes that can compromise the compliance of the file, as well as best practices to avoid them.



7.1. Key Points to Remember

  • Understand the required content: The technical file must include comprehensive information on the device’s design, manufacturing, clinical performance, and risk management.
  • Incorporate robust clinical evaluation: Clinical data must demonstrate the safety and effectiveness of the medical device, supported by solid studies or equivalence with similar devices.
  • Implement complete risk management: A thorough risk analysis, in compliance with ISO 14971, is essential to prove risk control throughout the device’s lifecycle.
  • Ensure continuous post-market surveillance: An effective PMS plan is crucial for maintaining the safety and compliance of the device after commercialization.
  • Avoid common mistakes: Do not neglect clinical data, risk management, or user documentation. Errors in these areas can significantly delay the validation of your technical file.


7.2. Importance of Expert Guidance

Although you can follow a structured framework to compile your technical file, the support of medical device regulatory experts can make the difference between a file that is quickly accepted and one that undergoes multiple revisions. Working with consultants who specialize in MDR will allow you to be more efficient and ensure compliance from the first submission.



7.3. Next Steps for Medical Device Manufacturers

If you haven’t yet started compiling your technical file, begin now by identifying the specific regulatory requirements for your device. Ensure you have the necessary internal resources or collaborate with consultants to guarantee that every step is carried out according to the MDR.


For those who have already submitted a file, remember that post-market surveillance is a continuous process. Ensure that you regularly update your technical file based on data collected after your device has been placed on the market.



7.4. Reach out to CSDmed

Are you a medical device manufacturer looking to ensure that your technical file complies with the MDR? Contact us today for tailored support in creating or reviewing your technical file. We help you simplify regulatory complexity while ensuring the compliance of your device.




8. FAQ: Frequently Asked Questions About the Technical File and the MDR


The regulations surrounding medical devices, especially with the implementation of the MDR (2017/745), can raise specific questions from manufacturers. This section aims to answer frequently asked questions to help better understand the requirements related to the technical file, CE marking, and the regulatory compliance process.



8.1. What is a technical file for a medical device?

A technical file is a set of documents that proves your medical device complies with the safety and performance requirements defined by the MDR. It contains technical information, clinical trial results, data on design and manufacturing, as well as a risk management plan. This file is essential for obtaining CE marking, which authorizes the sale of the device within the European Union.



8.2. What are the key elements of a technical file according to the MDR?

Key elements of a technical file include:

  • Detailed description of the device (materials, design).
  • Risk evaluation: Risk management throughout the product lifecycle.
  • Clinical data: Studies proving the device’s safety and efficacy.
  • Manufacturing process and material traceability.
  • Post-market surveillance plan (PMS): Ongoing monitoring after market release.


8.3. How do I obtain CE marking for a medical device?

To obtain CE marking, you must submit a complete technical file to a notified body for evaluation (for devices classified IIa and above). The file must demonstrate that your medical device meets the MDR’s safety and performance requirements. Once validated, the notified body will issue the CE marking, allowing your device to be marketed in Europe.



8.4. How long does it take to compile a technical file?

The time required to compile a technical file depends on several factors, such as the complexity of the device, risk class, and the availability of clinical data. Generally, for a complex device in Class IIb or III, it may take several years to gather and document all the necessary information. For Class I devices, the process may be quicker.



8.5. What common mistakes should be avoided when creating the technical file?

Here are some common mistakes to avoid:

  • Insufficient clinical data: Not providing enough solid clinical evidence.
  • Incomplete risk analysis: Not adhering to standards like ISO 14971.
  • Inadequate user documentation: Failing to include clear instructions for the use of the device.


8.6. What is the difference between Class I, IIa, IIb, and III medical devices?

The risk class of a medical device determines the complexity of the technical file and compliance requirements:

  • Class I: Low risk (e.g., bandages).
  • Class IIa: Moderate risk (e.g., syringes).
  • Class IIb: Higher risk (e.g., ventilators).
  • Class III: Highest risk (e.g., heart implants).

Devices in Class IIa and above generally require evaluation by a notified body, while some Class I devices can be self-certified by the manufacturer.



8.7. Why is post-market surveillance (PMS) important?

Post-market surveillance (PMS) is an ongoing process that allows for the collection of data on the real-world use of the device after it is marketed. A PMS plan ensures that any issues or incidents are identified quickly, and corrective actions are taken to ensure the safety of the device. It is a key requirement of the MDR and must be documented in the technical file.



8.8. How do you update a technical file?

A technical file must be updated regularly, especially based on the results of post-market surveillance or if modifications are made to the device (such as a change in material or a new indication). If these changes significantly impact the device’s safety or performance, the updates must be communicated to the notified bodies.



8.9. What are the consequences of an incomplete technical file?

An incomplete technical file can lead to the rejection of the CE marking application or delays in the evaluation process. Notified bodies may request additional information, which can prolong the time before your device is marketed. It is crucial to ensure that every section of the file is complete and up to date.