Medical Device File according to ISO 13485:2016

The version of 2016 of ISO 13485:2016 has a new requirement compared the previous version which is related to the so-called Medical Device File.

The medical device file (MDF) is basically what can be referred to the technical dossier, and it is basically the collection of all the data related the medical device in the field. We have already been talking about the design and development process and related documentation, including topics related to design validation and verification.

Medical Device File and Device Master Record

The contents of the MDF is very similar to the ones that should stay within the Device Master Record, that is a requirement according to 21 CFR 820. In fact, the section 21 CFR 820.181 specifies in details what the DMR shall include:

Each manufacturer shall maintain device master records (DMR’s). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with § 820.40. The DMR for each type of device shall include, or refer to the location of, the following information: 

• (a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications; 
• (b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications; 
• (c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; 
• (d) Packaging and labeling specifications, including methods and processes used; and 
• (e) Installation, maintenance, and servicing procedures and methods.

The device master record, for which a dedicated post has already been published within 4EasyReg website, is basically the collection of all the information needed to manufacture the specific medical device. It is a mandatory document according to FDA Quality System Regulation.

The contents of the Medical Device File according to ISO 13485

The requirements pertaining to the Medical Device File (MDF) are outlined in section 4.2.3 of ISO 13485:2016. In this section, it is specified that for each medical device family, the organization is obligated to create and maintain a comprehensive MDF. This file serves as a repository of all the essential documentation needed to demonstrate compliance with ISO 13485 and other applicable regulations.

As per ISO 13485:2016, the MDF should encompass the following key elements:

1. General Description: This includes a comprehensive overview of the medical device, its intended use or purpose, and relevant labeling information, including any instructions for use.
2. Product Specifications: Detailed specifications outlining the design, composition, and features of the medical device are essential components of the MDF. These specifications serve as a reference for ensuring that the device meets the necessary quality and performance requirements.
3. Manufacturing, Packaging, Storage, Handling, and Distribution: The MDF should contain specifications or procedures that cover all aspects of the manufacturing process, including packaging, storage, handling, and distribution. These procedures ensure consistency and quality throughout the device’s lifecycle.
4. Measurement and Monitoring: Procedures for measuring and monitoring various aspects of the device’s performance, quality, and safety should be documented in the MDF. These procedures enable the organization to track and assess the device’s performance over time.
5. Installation (if applicable): If the medical device requires installation, the MDF should include specific requirements and procedures for proper installation. These guidelines help ensure that the device is correctly installed and functions as intended.
6. Servicing (if applicable): In cases where servicing is required for the medical device, the MDF should outline the necessary procedures and requirements for servicing activities. This includes maintenance, repairs, and any other servicing-related tasks that may be applicable.

It is important to note that not all requirements listed above may be applicable to every medical device. Depending on the nature and characteristics of the device, certain requirements such as servicing or installation may not be applicable. In such cases, the organization should clearly indicate the exceptions and provide appropriate justifications in the MDF.

Design and Development Package

4 EasyReg has developed a full package of templates, procedures and other documentation ready to be used for the implementation or the improvements of your design and development process, an essential steps to reach an adequate level of regulatory compliance.

The Design Control Package includes the following documentation:

• Design Control Procedure
• Design & Development Plan Template
• Design Inputs Template
• Design Review Template
• Design Verification Plan Template
• DHF Index Template
• DMR Index Template
• Design Transfer Checklist

Do not hesitate to click on the link below for a full description of the package:

Medical Device File Procedure

In conclusion, we have delved into the requirements pertaining to the Medical Device File (MDF), highlighting the significance of this documentation in ensuring compliance with ISO 13485:2016 and the European Medical Device Regulation. As a testament to our commitment to providing comprehensive information, we have a specific procedure available at 4EasyReg DocShop, which can be readily downloaded for your convenience.

It is crucial to note that the inclusion of the medical device file as a requirement in the 2016 version of ISO 13485 marks a significant development. This requirement has gained even greater prominence and importance in light of the new European Medical Device Regulation. Compliance with these regulations necessitates meticulous preparation and maintenance of the MDF, underscoring the need for accurate and comprehensive documentation.

The availability of a dedicated procedure at 4EasyReg DocShop empowers organizations to navigate the intricacies of creating and managing the MDF with ease and confidence. By adhering to these guidelines and utilizing the provided resources, companies can ensure that their medical device file meets the necessary regulatory standards, facilitates seamless compliance, and contributes to the overall safety and quality of their medical devices.

Conclusions

In conclusions, we have been discussing the requirements associated to the Medical Device File with a reference to a specific procedure available at 4EasyReg DocShop that could be easily download. Medical device file is a new requirements added in the version 2016 of the ISO 13485 and this requirement became even more important with the new European Medical Device Regulation.

Compliance Checklist for Technical Documentation

To streamline the process of ensuring compliance with the technical documentation requirements outlined in MDR 2017/745, 4EasyReg has developed a comprehensive compliance checklist. This meticulously crafted checklist serves as a valuable resource for organizations seeking to assess the conformity of their technical dossier before submitting it to the notified body.

The Technical Documentation Checklist provided by 4EasyReg is designed to be an indispensable tool in simplifying the evaluation of your technical dossier’s compliance. With 15 pages of detailed guidance, this checklist covers all the essential elements that must be addressed to meet the stringent requirements set forth by the regulatory authorities. By utilizing this checklist, organizations can ensure that their technical documentation aligns with the necessary standards and guidelines.

The checklist, conveniently provided as a customizable Word file, offers the flexibility to tailor its contents to the specific product types and specifications relevant to your organization. This allows you to adapt the checklist to suit the unique characteristics and intricacies of your medical devices, ensuring a thorough and accurate assessment of compliance.

4EasyReg understands the complexities and challenges associated with preparing and submitting a technical dossier for regulatory approval. By providing this comprehensive and editable checklist, we aim to empower organizations in their pursuit of regulatory compliance. Our commitment to facilitating a smooth and efficient compliance process is reflected in the meticulous preparation of this checklist, which serves as a valuable aid for organizations navigating the intricate landscape of medical device regulations.

By leveraging the Technical Documentation Checklist, organizations can confidently review and assess their technical documentation, identify any gaps or areas of non-compliance, and take the necessary steps to rectify them before submission to the notified body. This proactive approach not only expedites the review process but also enhances the likelihood of obtaining timely regulatory approval, bringing your medical devices to market swiftly and effectively.

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4EasyReg is an online platform dedicated to Quality & Regulatory matters within the medical device industry. Have a look to all the services that we provide: we are very transparent in the pricing associated to these consulting services.

Within our WebShop, a wide range of procedures, templates, checklists are available, all of them focused on regulatory topics for medical device compliance to applicable regulations. Within the webshop, a dedicated section related to cybersecurity and compliance to ISO 27001 for medical device organizations is also present.

As one of the leading online platforms in the medical device sector, 4EasyReg offers extensive support for regulatory compliance. Our services cover a wide range of topics, from EU MDR & IVDR to ISO 13485, encompassing risk management, biocompatibility, usability, software verification and validation, and assistance in preparing technical documentation for MDR compliance.

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