MDR Documentation: Avoid Common Mistakes and Follow Best Practices

The Importance of Technical Documentation Under MDR for Medical Device Manufacturers

With the implementation of Regulation (EU) 2017/745, commonly known as the Medical Device Regulation (MDR), the requirements for medical device compliance in the European Union have become stricter and more complex. A key component of this compliance is the technical documentation, which must meet detailed and rigorous criteria to ensure the safety and performance of devices on the market.

For medical device manufacturers, mastering the expectations related to the preparation and submission of this documentation is crucial. Poor organization, incomplete data, or inconsistencies can lead to significant delays or even rejections by notified bodies. It is in this context that best practice guidelines, such as those proposed by Team-NB, play a critical role by providing harmonized recommendations on how to structure and present technical documentation.

In this article, we will outline the essential elements to include in your MDR technical documentation, common mistakes to avoid, and best practices to ensure a successful submission. Whether you are already working on your documentation or seeking to better understand the expectations of notified bodies, this guide will provide key insights to help you navigate this complex process.

What Is MDR Technical Documentation?

Technical documentation is one of the central pillars of regulatory compliance for medical devices under Regulation (EU) 2017/745, known as the Medical Device Regulation (MDR). It encompasses all the information and evidence needed to demonstrate that a medical device meets essential safety and performance requirements before it is placed on the market. This documentation is a comprehensive and detailed file, submitted to the notified body for evaluation and approval.

Objectives of Technical Documentation

The primary goal of technical documentation is to ensure that the medical device can be used safely and effectively by patients. It proves that the product complies with European regulatory standards by integrating all necessary evidence, from the device’s design to its post-market surveillance (PMS). Well-prepared technical documentation is not only a prerequisite for obtaining CE marking but is also essential for maintaining compliance throughout the device’s lifecycle.

Regulatory Framework: MDR Annex II

The regulatory framework for technical documentation is defined in MDR Annex II, which specifies the different sections and information that must be included. Each section of the technical documentation is structured to cover a specific aspect of the medical device, ensuring that all relevant evidence is provided in a clear and accessible manner. These sections include:

1. Device Description and Specifications

This section must provide a detailed description of the device, including its variants, accessories, materials used, and the technical specifications that define its performance. It also includes information on packaging and labeling configurations to ensure the product is correctly identified throughout its distribution chain.

2. General Safety and Performance Requirements (GSPR)

These requirements are established in Annex I of the MDR and must be demonstrated through clear and verifiable data. This is a key element of the documentation, proving that the device meets safety and performance standards under various conditions of use.

3. Risk Management

Risk management is an integral part of the medical device development process. This section must present a solid risk management plan, covering all aspects, from the identification of potential hazards to the validation of risk control measures implemented.

4. Product Verification and Validation

Manufacturers must include concrete evidence that the device has passed all testing phases, including biocompatibility tests, software validation (if applicable), and packaging stability tests. These verifications ensure that the product is safe and performs as intended.

5. Post-Market Surveillance (PMS, Annex III)

Once the product is on the market, it must be continuously monitored to assess its real-world performance. This section of the technical documentation covers post-market surveillance plans, including post-market clinical follow-up (PMCF) procedures.

Why Is Well-Structured Technical Documentation Crucial?

MDR technical documentation must not only be complete but also well-organized and easy to navigate for notified bodies who will review it. According to MDR Annex II, the documentation must be “clear, organized, readily searchable, and unambiguous.” A lack of consistency or missing information can lead to significant delays in the certification process or result in non-conformities.

In summary, properly structured technical documentation is essential to ensure that the medical device can be placed on the market and remains compliant throughout its lifecycle.

What is the content of a technical file?

The technical documentation required under Regulation (EU) 2017/745 (MDR) consists of several essential sections that allow a medical device’s compliance with safety and performance requirements to be proven. This documentation must be comprehensive enough for the notified body to assess the device’s safety and performance throughout its lifecycle. Here are the main components of this documentation, as defined in MDR Annex II:

1. Device Description and Specifications

This section forms the first essential step in the technical documentation. It must provide a detailed description of the medical device, including:

• The trade name of the device and its specific references (including the Basic UDI-DI).
• The device’s variants and accessories, including available packaging configurations (e.g., a device sold individually or in multipacks).
• The class of the device and the justification for the classification rules applied, according to Annex VIII.
• The key functional elements and technical characteristics, such as the raw materials used in manufacturing.
• The technical specifications of the product, detailing its performance and characteristics.

Common Non-Conformities to Avoid:

• Inconsistent information about the product’s variants.
• Incomplete descriptions of the raw materials used, particularly for components that have direct or indirect contact with the human body.

2. General Safety and Performance Requirements (GSPR)

The GSPRs are defined in Annex I of the MDR and cover the fundamental safety and performance aspects that every medical device must meet. In the technical documentation, you must:

• List all applicable GSPRs for your device and explain (justify) why some may not apply (if relevant).
• Provide methods to demonstrate compliance with each applicable GSPR. This may include the use of harmonized standards, common specifications (CS), or other solutions.
• Attach tangible evidence of compliance, such as test results or validation reports.

Common Non-Conformities to Avoid:

• Failing to provide justification for alternative solutions used when harmonized standards are not applied.
• Omitting to list the precise versions or editions of the standards applied, making it difficult to verify compliance.

3. Risk Analysis and Risk Management

Risk management is a key component to ensuring the device’s safety throughout its lifecycle. The risk management process includes identifying hazards, assessing the risks associated with device use, and implementing control measures to mitigate these risks. This section should include:

• A detailed risk management plan covering each stage, from design to clinical use.
• A risk assessment linked to the results of preclinical and clinical trials, including verifying that identified risks have been effectively controlled.
• Evidence of the effectiveness of the risk control measures implemented, such as the validation of the methods used to reduce risks.

Common Non-Conformities to Avoid:

• Lack of a clear link between preclinical trial results and risk control measures.
• Failure to distinguish between the verification of the implementation of risk control measures and the assessment of their effectiveness.

4. Product Verification and Validation

This section focuses on demonstrating that the medical device has been thoroughly tested to ensure it performs as expected and is safe for patients. It includes preclinical tests, design verifications, and process validations. Common tests included in this part are:

• Biocompatibility: The materials of the device must be tested to ensure they do not cause harmful reactions when in contact with the human body.
• Software Validation: If the device includes software, it must be tested to ensure its functionality and safety, including cybersecurity.
• Electrical Safety and Electromagnetic Compatibility (EMC): Electrical devices must be tested to ensure they meet safety standards and do not interfere with other medical equipment.
• Packaging Stability and Shelf-Life: These tests ensure that the medical device remains sterile and functional throughout its shelf life.

Common Non-Conformities to Avoid:

• Failure to include complete test protocols or a critical analysis of the data resulting from the tests.
• Failing to justify non-harmonized or country-specific tests (e.g., tests based on ASTM standards).

5. Post-Market Surveillance (PMS)

Post-market surveillance is essential to ensure that the medical device continues to meet safety and performance requirements once it is on the market. The manufacturer must establish a PMS plan that includes:

• The collection of data on the device’s performance after it has been placed on the market.
• Post-market clinical follow-up (PMCF) for high-risk devices, aimed at gathering additional clinical data.
• Surveillance reports (PSUR) for Class IIb and III devices, with regular updates on the product’s safety and performance.

Common Non-Conformities to Avoid:

• A PMS plan that does not take into account all available market data (e.g., user feedback).
• Failing to regularly update the PSUR to reflect new post-market surveillance data.

Common Non-Conformities in MDR Technical Documentation

One of the main causes of delays or rejections in technical documentation submissions under MDR is the presence of non-conformities. These often avoidable errors can result in clarification requests or rejections from notified bodies. Here are the most common non-conformities to watch for when preparing technical documentation:

1. Inconsistencies in Device Descriptions

Inconsistencies in names, references, or device variants across the technical documentation and other submitted documents (certificates, EUDAMED records, etc.) can cause confusion. Ensure that information about accessories, variants, and packaging is consistent throughout all documents.

2. Insufficient Data for GSPR Compliance

It is common for manufacturers to provide insufficient details about the methods used to demonstrate compliance with General Safety and Performance Requirements (GSPR). This includes the absence of justifications for alternative methods used or a lack of tangible evidence for each requirement.

3. Lack of Data in Risk Analysis

The absence of a clear link between the risk analysis, the results of clinical or preclinical trials, and the control measures implemented can lead to non-conformities. It is crucial to demonstrate that identified risks have been adequately evaluated and that control measures are validated.

4. Incomplete Verification and Validation Data

Another recurring issue is the lack of critical analysis of test data or incomplete validation protocols. Each test conducted (biocompatibility, software tests, packaging stability, etc.) must be accompanied by a clear explanation of its results and relevance to the device.

5. Insufficient Post-Market Surveillance (PMS) Plan

Many manufacturers fail to include a detailed PMS plan or do not continuously monitor devices post-market. A robust PMS plan, with regular updates via the PSUR (Periodic Safety Update Report), is essential for Class IIb and III devices.

Best Practices for MDR Submission

Successfully submitting your technical documentation under Regulation (EU) 2017/745 (MDR) requires meticulous preparation and attention to detail. A well-structured and compliant submission can not only accelerate the evaluation process but also prevent costly delays and non-conformities. Here are the best practices to follow for a successful submission:

1. Clear Organization and Unified Structure

One of the primary expectations of notified bodies is a documentation set that is clearly structured and easy to review. According to MDR Annex II, the documentation must be “clear, organized, readily searchable, and unambiguous.” To ensure this:

• Organize documents into logical and distinct sections, following the requirements of Annex II. Use a hierarchical structure with well-labeled folders and subfolders.
• Use descriptive file names to avoid confusion. For instance, avoid file names like “doc1” or “TD001”; instead, use titles like “Biocompatibility_Test_2023” or “Software_Validation_Report.”
• Ensure all documents are legible, with no inverted pages or incorrectly scanned documents. A poorly scanned document could result in a delay or a request for resubmission.

2. Consistency in Provided Information

Consistency is key to a successful MDR submission. The information contained in your technical documentation must match perfectly with that in other regulatory and commercial documents (certificates, EUDAMED records, labels). To achieve this:

• Ensure complete consistency across all documents, including device names, references, Basic UDI-DI, and the variants mentioned in other documents (declaration of conformity, clinical reports, labeling).
• Simultaneously update all documents when modifications are made to a product. Even minor inconsistencies can lead to requests for clarification or non-conformities.

3. Careful Selection of Compliance Demonstration Methods

To demonstrate compliance with the General Safety and Performance Requirements (GSPR), it is essential to choose recognized and justified methods. Using harmonized standards is often the best choice. However, if alternative solutions are applied:

• Always justify the use of alternative methods, explaining why they are equivalent or superior to harmonized standards.
• Always specify the exact versions of the standards or specifications applied to ensure traceability and compliance with the state of the art.

4. Robust and Updated Risk Management Plan

A poorly structured or incomplete risk management plan can raise questions from the notified body. To avoid this:

• Provide a comprehensive risk management plan, detailing each identified risk, the control measures applied, and the evidence of their effectiveness. This plan should be updated based on the results obtained during clinical and preclinical trials.
• Incorporate a critical analysis of the results from each test and explicitly link them to the corresponding GSPR to prove that risks are adequately controlled.

5. Proactive Post-Market Surveillance (PMS)

Post-market surveillance (PMS) is an ongoing obligation to ensure that the medical device remains compliant and performs well once on the market. To meet MDR expectations:

• Implement a detailed PMS plan, tailored to the risk class of your device. This plan should include methods for collecting data on incidents or user feedback.
• Regularly conduct post-market clinical follow-up (PMCF) for Class IIb and III devices, particularly implantable devices. This follow-up allows for the collection of additional clinical data to ensure the product’s long-term safety.
• Periodically submit PSUR reports for Class IIb and III devices, as required by Article 86 of the MDR. These reports allow for updates on the product’s performance and safety.

6. Careful Preparation of Clinical Reports

Clinical data plays a central role in demonstrating the safety and performance of the medical device. To avoid negative feedback from the notified body:

• Ensure that clinical evaluation reports (CER) are complete and well-structured. Simply “updating” an existing clinical report is insufficient; each report must be exhaustive and up-to-date.
• Include all relevant data from post-market surveillance, including incidents and ongoing clinical investigations, to demonstrate continuous compliance.

Conclusion

The submission of technical documentation under Regulation (EU) 2017/745 (MDR) is a critical and demanding process for ensuring the compliance of medical devices in the European market. Each component of this documentation, whether it is the detailed description of the device, risk management, or clinical evidence, plays a crucial role in demonstrating the device’s safety and performance.

To successfully complete this submission, it is essential to follow best practices: structure your documents clearly and consistently, provide solid justifications for each step of the compliance demonstration, and ensure that all data is up-to-date and perfectly aligned. By adopting a proactive approach, particularly regarding post-market surveillance, you ensure not only the initial success of your submission but also the continued compliance of your product over the long term.

Ultimately, well-prepared technical documentation accelerates the certification process, minimizes the risk of non-conformity, and ensures that your medical device can be used safely by patients. If you would like additional guidance or assistance in preparing your MDR submission, feel free to contact us.

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