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Technical File for Medical Devices: Essential Guide & Compliance Tips
At the heart of bringing a medical device to market is the Technical File (TF), a collection of documents proving that a product meets the necessary regulatory requirements. This blog post explains what a Technical File for medical devices is, why it is important, it's requirements, structure, and management.
What Is a Medical Device Technical File?
A Medical Device Technical File is a dossier containing all the documentation needed to demonstrate compliance with regulatory requirements before a device can be marketed or sold. It's evidence that a device has been designed, manufactured, and can be sold within the EU, fulfilling all legal obligations. The Technical File is a typical term used in Europe. Here are some of the most common terms for Technical Files used in the Medical Device industry.
The Technical File is essential for devices seeking approval in the European Union, underlining conformity with the Medical Devices Regulation (MDR), and is a critical step towards achieving CE marking.
What Are the Requirements for Medical Device Technical Documentation?
The requirements for Medical Device Technical Documentation are extensive, ensuring that devices are safe and effective for their intended use. Documentation must cover the design, manufacture, and operation of the product, including detailed information on the materials, design, manufacturing process, and performance of the device.
Technical documentation and QMS are two pillars to get approval. Although the technical file does reference some of the procedures tegulatory bodies require this documentation to assess the device's compliance. This can be assessed through stanadards and regulations such as ISO 13485 and CFR part 820. A Quality Management System (QMS) is also essential to support the ongoing compliance and maintenance of the Technical File.
What is the Structure of a Technical File?
The structure of a Technical File is crucial for its review and approval. You can review our latest post on the Design History File (DHF) to understand how it's structured. It typically includes the following sections:
Device Description and Specification
This section provides a detailed description of the medical device, including its intended use, indications, contraindications, and user population. It outlines the device's specifications, including sizes, materials, and components.
Labeling and Instructions for Use
Documentation of the device's labeling, packaging, and instructions for use, ensuring they are clear, accurate, and in compliance with regulatory standards.
Design and Manufacturing Information
Comprehensive records of the design and manufacturing processes, including design development, manufacturing procedures, and quality control measures.
General Safety and Performance
Evidence of the device's safety and performance, including clinical evaluations, biocompatibility studies, and electrical safety tests.
Risk Management Documentation
Documentation of the risk management process throughout the device's lifecycle, in line with ISO 14971 Risk Management, detailing hazard identification, risk analysis, and control measures.
Verification and Validation Information
Records of verification and validation activities, including testing protocols, test results, and critical analyses, proving that the device meets its intended purpose and specifications.
Post-Market Surveillance (PMS)
Plans and reports for ongoing surveillance after the device is marketed, monitoring its performance and safety.
Who Reviews a Technical File?
The review of a Technical File is typically conducted by a Notified Body (except for Class 1 Medical Devices), a third-party organization designated by regulatory authorities to assess the conformity of certain products before they are marketed. For medical devices, the Notified Body examines the Technical File to ensure compliance with the relevant regulatory requirements and standards. The successful review and approval of the Technical File allow the manufacturer to affix the CE mark to their device, signifying its readiness for the European market.
Choosing the Optimal Software to Manage Your Medical Device Technical File
Managing a Technical File can be complex and time-consuming. MatrixALM offers a sophisticated solution designed to streamline the creation, maintenance, and updating of Technical Files.
Matrix Requirements is specifically tailored as an aid for medical device manufacturers to help ensure compliance with regulations and standards like ISO 13485, MDR, and CFR part 820. Matrix's solution enhances efficiency, reduces errors, and ensures that your Technical File is always audit-ready.
Choosing Matrix for managing your Medical Device Technical File not only simplifies regulatory compliance but can also accelerate 3x the time-to-market for medical devices, making it an invaluable tool for medical device manufacturers aiming for excellence in a competitive industry.
The Technical File is a cornerstone of medical device regulatory compliance, providing a detailed account of a device's design, safety, and efficacy. Understanding its requirements, structure, and the importance of effective management software like Matrix Requirements, is essential for manufacturers navigating the complex regulatory landscape of medical devices.