Introduction – A medical device technical file is an all-inclusive document that includes all technical data and information about a medical device, including risk management, design, manufacture, testing, and clinical evaluation. It proves the device’s compliance with relevant regulatory standards, such as the US Food and Drug Administration (FDA) rules or the European Medical Device Regulation (MDR). It is a crucial component of the medical device conformity assessment process. The technical File usually includes detailed information about the intended use of the device, technical specifications, parts, materials, manufacturing methods, sterilization, packing, labelling, and usage instructions.

The FDA 21 CFR Part 820 regulation in the US refers to a comparable document as the Device Master Record (DMR).

In the United States, according to FDA 21 CFR Part 820 regulation, all medical device-related records consist of the device master record (DMR), device history record (DHR), and design history file (DHF). The DHR, DHF, DMR, and Technical Files, or Technical Documentation, are all crucial records for medical device regulatory compliance and to prove the device’s efficacy and safety despite having distinct uses in various markets.

Why Is Technical Documentation for Medical Devices Important?

• Technical documentation for medical devices is crucial because it shows that the equipment is safe and suitable for its intended purpose.
• By carefully documenting every facet of the product, manufacturers can prove to regulatory bodies that a medical device meets all safety and performance standards.
• Technical documentation is also necessary for approval procedures and conformance evaluations.
• Medical devices cannot be marketed or sold in the European Economic Area (EEA) unless they are Class I non-sterile, non-reusable surgical tools or are approved by a notified body. These devices do not include measuring function devices. For the approval process to proceed, a medical device technical file must be submitted.
• The technical documentation also aids in identifying and resolving issues if a medical device fails or causes harm, safeguarding the public’s health and maintaining the manufacturer’s good name.
• Gathering the enormous amount of technical documentation required for a medical device technical file is a difficult and complex procedure.

Is a Technical File Necessary?

• Medical devices sold and marketed within the European Economic Area (EEA) must have a medical device technical file.
• A medical device’s technical File must be created and submitted as part of the conformity assessment procedure before it can be sold lawfully. The File is crucial for proving conformity with pertinent regulatory standards, including the European Medical Device Regulation (MDR).
• If the medical device, its intended use, or its manufacturing process undergoes significant modifications, the technical File may need to be updated and resubmitted.
• However, depending on how the EU classifies medical devices, different requirements may apply to a technical file.
• Notification bodies are not obliged to receive the technical File from Class I devices that are non-sterile, non-reusable surgical tools and do not have measuring features. Due to their low risk, these devices can self-certify as compliant with EU standards.
• Nevertheless, a few manufacturers have decided to keep a medical device technical file since it lowers risk, adds value, and proves compliance.

What Technical Documentation Requirements Apply to Medical Devices?

The following criteria apply to technical documentation for medical devices:

• Medical Device Regulation (MDR)
• In Vitro Diagnostic Regulation (IVDR)
• ISO 13485:2016
• Regulation of Medical Devices (MDR).

The current European Union rule controlling medical devices is rule 2017/745, usually referred to as the Medical Device Regulation (MDR). The Medical Device Directive (MDD) was superseded by the MDR, which went into force in May 2021.

Annex II and Annex III of the MDR outline the specifications for technical documentation related to medical devices.

Annex II provides a detailed inventory of all the data that manufacturers need to provide in their technical paperwork to prove the efficacy and safety of their products.

Among the technical documentation components of MDR Annex II are:

• Device description and specification, including variants and accessories
• The primary unique device identifier (UDI) code –
• Principles of operation of the device and its mode of action
• Detailed information regarding test design, study protocols, and methods of data analysis
• Label and packaging information
• Instructions for use in the languages where the device is going to be sold
• Design and manufacturing information
• Identification of all sites, including suppliers and sub-contractors
• General safety and performance information
• Benefit-risk analysis and risk management
• The risk class of the device and the justification for the classification rule
• Product verification and validation
• Software verification and validation
• The clinical evaluation plan and clinical evaluation report

Annex III specifies the requirements for technical documentation on post-market surveillance.

• The manufacturer needs to gather data in a proactive and organized manner so that they can create thorough technical documentation, such as a post-market monitoring strategy.
• The post-market monitoring plan must cover data collection and use related to minor occurrences, significant incidents, and unfavourable side effects. It consists of user comments and grievances, data from trend reports, and pertinent specialized or technical literature.
• Manufacturers must establish an MDR-compliant Quality Management System (QMS) that satisfies the precise requirements listed in the legislation to guarantee compliance with EU MDR.

What is the requirement for technical documentation stated in ISO 13485;2016?

What ISO 13485 states is as follows:

4.2.3 File for medical devices – The organization is required to establish and maintain one or more files, either containing or referencing documents generated to demonstrate compliance with applicable regulatory requirements and this International Standard, for each type or family of medical devices.

The File (s)’ contents must contain, but are not restricted to:

1. A) A general description of the medical device, its intended use, and its labelling, including any usage instructions;
2. B) product specifications;
3. C) manufacturing, packaging, storage, handling, and distribution specifications or procedures;
4. D) measuring and monitoring procedures;
5. E) installation requirements as necessary;
6. F) servicing procedures as necessary.

Conclusion – The creation and maintenance of a medical device technical file are essential for ensuring regulatory compliance, device safety, and performance. The technical File, encompassing detailed information on the device’s design, manufacturing, and clinical evaluation, serves as a cornerstone for demonstrating conformity with standards such as the FDA’s regulations in the US and the European Medical Device Regulation (MDR). This comprehensive documentation not only facilitates the approval and market entry of medical devices but also plays a critical role in ongoing post-market surveillance, helping to identify and address potential issues promptly. Ultimately, thorough and well-maintained technical documentation is not just a regulatory requirement but a key element in the lifecycle of a medical device, enhancing its value and reliability in the marketplace.

How ND Global Can Help – At ND Global Consulting Inc., we specialize in providing comprehensive support for the creation, maintenance, and compliance of medical device technical documentation. Our expertise spans regulatory compliance, quality assurance, and top-tier staffing, ensuring that your medical device meets all necessary regulatory standards and performs safely and effectively. Here’s how we can assist you:

• Regulatory Compliance Expertise – Our team of regulatory experts is well-versed in the FDA’s 21 CFR Part 820 regulations and the European Medical Device Regulation (MDR). We help you navigate the complex regulatory landscape, ensuring that your technical documentation is thorough, accurate, and compliant with all relevant standards.
• Technical File Creation and Maintenance – We assist in developing comprehensive technical files that include all necessary information, such as device descriptions, intended use, technical specifications, manufacturing processes, and clinical evaluation data. Our meticulous approach ensures that every aspect of your product is documented to meet regulatory requirements.
• Post-Market Surveillance Support – ND Global provides ongoing support for post-market surveillance, helping you gather and analyze data related to device performance and safety. We assist in creating robust post-market monitoring plans that include user feedback, incident reports, and trend analysis, ensuring continuous compliance and improvement.
• Customized Solutions – Understanding that every client has unique needs, ND Global offers tailored solutions that address specific regulatory challenges and documentation requirements. Our personalized approach ensures that your medical device technical documentation is not only compliant but also optimized for efficiency and clarity.
• By partnering with ND Global, you gain access to a wealth of experience and expertise, ensuring that your medical device meets all regulatory standards and performs reliably in the marketplace. Our commitment to excellence and comprehensive support services make us the ideal partner for all your technical documentation needs.