How to Prepare a Medical Device Technical File

It’s essential to have a comprehensive, well-documented technical file for your medical devices to ensure compliance with regulations and guarantee the safety and effectiveness of your products.

In this blog, we’ll cover the following topics regarding preparing a medical device technical file:

What Is a Medical Device Technical File?
The Importance of Medical Device Technical Documentation
When Is a Technical File Required?
Medical Device Technical File Requirements
Medical Device Technical File Contents
MDR Technical File Checklist
How Is a Medical Device Technical File Reviewed?

Female doctor working on smart device in the medical office at the hospital

What Is a Medical Device Technical File?

Before you can get a Conformitè Europëenne (CE) Mark, you must submit a technical file to the regulatory authorities. This mandatory document is your chance to prove that your devices are safe, effective, and designed for their intended use. Similar to a US FDA regulatory submission, a medical device technical file is essential for EU regulatory agencies. By complying with the Medical Devices Directive 93/42/EEC, In Vitro Diagnostic Medical Devices Directive 98/79/EC, and Active Implantable Medical Devices Directive 90/385/EEC, you can ensure your devices meet the highest standards.

The Importance of Medical Device Technical Documentation

The technical documentation for your devices is essential for approval and ongoing inspections. Not only is it required for selling your devices in the EU, but it’s also subject to scrutiny by the US FDA and ISO 13485:2016 audits. From the very beginning of product development, careful planning and preparation of the technical file is a must. This means it goes hand-in-hand with the creation of your amazing medical devices. To ensure a smooth approval process and regular compliance, keep your technical file clear, organized, and up-to-date.

When Is a Technical File Required?

A technical file is required for all devices except for Class 1 devices, which aren’t sterile and don’t have a measuring function. If you decide to work with a Notified Body, they will carefully scrutinize your technical files to ensure compliance.

Medical Device Technical File Requirements

According to the EU declaration of conformity, the following are required for a medical device technical file:

Technical documentation must be ready before placing your product on the market.
Market surveillance authorities may request the technical document once your product is available.
The technical documentation should be kept updated for 10 years from the date of placing the product on the market.

According to Annex II of the EU MDR 2017/745, your technical file should include the following:

Description and specification of your medical device
Detailed labeling and packaging information
Instructions in all official EU languages
Information about your company’s design and manufacturing activities
Pre-clinical and clinical data
Post-market surveillance planning and report
Declaration of conformity

Make sure your medical device technical file is complete and up-to-date to comply with regulations.

Medical Device Technical File Contents

Properly structured technical documentation is essential for medical device manufacturers. It ensures that regulatory inspectors can easily understand the contents of the device’s technical file, and with a well-organized structure, it’s easier to update different sections as needed.

According to the EU MDR 2017.745, a medical device technical file should include essential details, such as a product description, labeling and usage instructions in the official language of the target market, design and manufacturing information, safety and performance requirements, and product verification and validation data.

To ensure consistency and standardization across markets, many medical device manufacturers use the Summary Technical Document (STED) format, which is recognized by Europe, the USA, Australia, and Japan. Some Notified Bodies in Europe even provide detailed guidelines on how to format technical files.

By following these guidelines, manufacturers can streamline the regulatory process, enhance safety and performance, and effectively bring their medical devices to market worldwide.

MDR Technical File Checklist

Don’t forget these key items when putting together your medical device technical file:

Device description and specs: Include a general description of your product, technical specs, and product/trade name with the unique device identifier (UDI).
Information supplied by manufacturer: Provide instructions for use, packaging and labeling details, and manufacturing/expiry dates.
Design and manufacturing information: Explain the product’s design, manufacturing process, quality control protocols, and details about all manufacturing sites.
General safety and performance requirements: Include verification and validation reports, clinical evaluation reports, biological evaluation reports, and post-market surveillance plan and reports.
Risk assessment: Make sure to cover all aspects of your product’s safety risk management system throughout its lifecycle.
Declaration of conformity: The final section of your document should have the names and signatures of the manufacturer or authorized representatives declaring compliance with all required EU regulatory requirements.

A well-structured medical device technical file is crucial for ensuring the safety and effectiveness of your product.

Learn about each step for getting a CE certification for medical devices with this guide.

Learn More

How Is a Medical Device Technical File Reviewed?

Notified Bodies play a crucial role in assessing the documentation provided for each device. The assessment follows a risk-based approach, ensuring that the benefits of the device outweigh any potential risks. Cutting-edge technologies are taken into account to minimize risks, which must also be acceptable throughout the certification period. Let’s take a look at the different device classes:

Class IIb active & implantable devices (exceptions apply) and Class III devices are assessed individually.
Class IIb medical devices (excluding the above) and Class II devices are evaluated based on representative devices from each group.
Class I devices that are sterile, have measuring functions, or contain reusable surgical instruments are evaluated specifically for those features. Other Class I devices require a declaration of conformity.

Before submitting the technical file to a Notified Body, it’s important to review the documentation internally. Conducting an internal audit involving personnel from various departments ensures thoroughness. For an additional perspective, consider hiring an external medical device consultant.

Key Takeaways

Navigating MDR requirements can be a daunting task.

With over 30 years of experience in the field, Remington Medical knows the ins and outs of medical device manufacturing better than anyone else. Our team of experienced professionals is ready to go the extra mile to ensure your compliance with all the technical file documentation requirements, making the process a breeze for you. Contact us today to learn more.