What is the technical file content of MDR?
Under the European Union's Medical Device Regulation (MDR), the technical file (or technical documentation) is a comprehensive set of documents that provides detailed information about a medical device. This documentation is required for both pre-market submission and post-market maintenance, ensuring that the device complies with regulatory standards throughout its lifecycle.
Here’s a breakdown of the typical content needed for a technical file under the EU MDR:
- Device Description and Specification:
- Detailed description of the device and its intended use.
- Specifications, including the design, physical, and technical parameters.
- Variants and accessories of the device.
- Information on the Design and Manufacturing Process:
- Detailed information on the design stages, key design outputs, and manufacturing processes.
- Descriptions of the methods and controls used in the manufacturing, packaging, and sterilization processes.
- Risk Management:
- The Risk management file, per ISO 14971, details the risk analysis, evaluation, and control measures.
- Information on the overall risk-benefit analysis and any residual risks.
- General Safety and Performance Requirements:
- Assessment of conformity with relevant General Safety and Performance Requirements (Annex I of the MDR).
- Applicable standards and guidance documents used to demonstrate conformity.
- Clinical Evaluation:
- Clinical evaluation report (CER) according to MEDDEV 2.7/1 rev. 4 and the MDR.
- Description of clinical data, the analysis of that data, and how it supports the device’s intended purpose.
- Labeling:
- Copies of the labeling, instructions for use, and any promotional materials.
- Post-Market Surveillance Plan:
- A plan detailing how the manufacturer will collect and evaluate performance data of the device post-market to ensure continued safety and performance.
- Additional Information:
- Results of any biocompatibility testing, validation studies of sterilization and packaging, software verification and validation, and other relevant testing.
- Declarations and certificates from notified bodies or other regulatory compliance documents as required.
This technical documentation is crucial for Notified Bodies during the conformity assessment process and must be kept up-to-date and reviewed regularly. It serves as a detailed dossier of every device aspect, from design rationale to manufacture and ultimately, post-market activities, ensuring the device meets all required regulatory and safety standards.
What is the difference between technical file and technical documentation?
The terms "technical file" and "technical documentation" are often used interchangeably in the context of medical device regulations, particularly under European Union regulations. However, their usage can vary slightly depending on the context or specific regulatory framework.
Technical File: Traditionally, this term has been used more specifically to refer to the compilation of documents that manufacturers must prepare to demonstrate compliance with the relevant directives, such as the Medical Devices Directive (MDD) or the Active Implantable Medical Devices Directive (AIMDD). A technical file is typically focused on a specific medical device or product family and includes detailed information necessary for assessing conformity to the applicable directives. It is primarily used in dealings with Notified Bodies to obtain CE marking.
Technical Documentation: With the new Medical Device Regulation (MDR) introduction, the term "technical documentation" has become more prevalent. It encompasses a broader scope, aligning with the same requirements previously associated with the technical file but under a more unified and expansive framework. Technical documentation under MDR includes all the details needed to demonstrate compliance with the regulation, covering all stages from design and manufacture to post-market surveillance.
While both terms describe the detailed dossiers prepared by manufacturers to fulfill regulatory requirements, "technical documentation" under the MDR represents a more modern and comprehensive approach, reflecting the evolution of regulatory standards in ensuring medical device safety and effectiveness.
How do you create a technical file?
Creating a technical file for a medical device, especially to meet the European Union's Medical Device Regulation (MDR) requirements, involves compiling comprehensive documentation to demonstrate the device's compliance with regulatory standards. Here’s a step-by-step guide on how to create a technical file:
- Define the Device: Clearly describe the medical device, including its intended use, features, and functionalities. Include all variants and accessories.
- Gather Design Specifications: Document the design process, including design inputs, outputs, and verification and validation processes. Include detailed drawings, schematics, and software specifications if applicable.
- Compile Manufacturing Information: Provide details on the manufacturing process, including the facilities, materials used, critical processes, and quality control measures. Include information on packaging, labeling, and sterilization where relevant.
- Conduct Risk Management: Perform a risk analysis and management according to ISO 14971. Document all identified risks, their evaluation, and the mitigation measures implemented. Include a risk management report.
- Perform and Document Clinical Evaluation: Conduct a clinical evaluation following MEDDEV 2.7/1 rev. 4 guidelines and the MDR requirements. Gather and analyze clinical data to support the safety and efficacy of the device.
- Ensure Compliance with General Safety and Performance Requirements: Evaluate the device against the relevant General Safety and Performance Requirements (Annex I of the MDR). Use harmonized standards where available to demonstrate conformity.
- Prepare Product Labeling and Instructions: Develop clear and compliant labeling, including user manuals, labels, and packaging. Ensure all necessary information like device function, usage instructions, warnings, and regulatory markings (e.g., CE mark) are included.
- Develop a Post-Market Surveillance Plan: Outline how ongoing compliance, safety, and performance will be monitored after the device is on the market. Include plans for collecting and evaluating post-market data.
- Assemble Technical Documentation: Organize all the documents in a structured manner, making it easy for a Notified Body to review. Include a table of contents and ensure all documents are current and readily accessible.
- Keep the Documentation Updated: Continually update the technical file to reflect any changes to the device, manufacturing process, or regulatory requirements, as well as new information from post-market surveillance.
Creating a technical file is a meticulous process requiring ongoing attention and updates. The file must be thorough enough to demonstrate compliance with all applicable regulations and ready for audit by the Notified Body at any point.
