What is a medical device technical file and why is it important?

A technical file is a document that contains a comprehensive overview of information and documentation showing a medical device meets the requirements listed in the European Union’s Medical Device Regulation (MDR) 2017/745. The technical file serves as a record of the device's development, including its design files, performance and safety testing, packaging and labeling, and clinical evaluation. Think of it as the DNA of your medical device. 

The technical file is used by regulatory authorities of the EU (called notified bodies) or the designated member country to assess the safety, performance, and quality of the medical device. Properly maintaining a medical device’s technical file from conception of the medical device to post-market access of the device is paramount to remaining compliant with MDR 2017/745, as the European Union requires consistent updating with device changes, new information, and current scientific research. Maintaining a technical file can feel like a full-time job of crossing your t’s and dotting your i’s but don’t worry, we will help you understand how to do so easily and accurately.

What goes into a Technical File?

A technical file includes key elements necessary to show safety and intended performance of the medical device. We summarized ten areas that must be completed within the technical file. These areas are:

• Manufacturer Information and Device Descriptions and Specifications: this area includes general information about the manufacturer and the device. This includes the device’s intended purpose and principles for how it operates. Other important information to include is the Declaration of Conformity, authorized representative, and a description of the Quality Management System.
• Labeling / Instructions for Use: this area ensures that the label and IFU include necessary safety information, regulatory symbols like the CE mark, and contains understandable languages of where the device is intended to be sold.
• Design and Manufacturing Information: the area consists of an outline of the design of the device and how it was manufactured, including the use of subcontractors.
• Packaging and Shelf-Life: This area consists of how your product will be packaged and that it will protect your product in transit and in storage.
• General Safety and Performance Requirements: this area must show systematic compliance with the General Safety and Performance Requirements outlined in MDR 2017/745.
• Risk Management: this area includes a risk management plan, a risk analysis including risk control measures, and a risk management report including the evaluation of residual risks and the evaluation of benefit-risk ratio.
• Biocompatibility and Safety Testing: this area identifies any safety testing you performed for biocompatibility (if applicable), electrical safety or other safety aspects like electro/magnetic fields. Ensure to include any testing laboratories used and their accreditations.
• Product Verification and Validation: this area must provide a summary evaluation or a statement for non-applicability for the variety of tests outlined in MDR 2017/745. For software containing products, a dedicated software area exists to describe your specifications, verification/validation processes, and cybersecurity analysis.
• Clinical Evaluation and Usability: this area contains your clinical evaluations and investigations and any human factors testing for your device’s usability to ensure it performs as intended and is safe for use in humans.
• Technical Documentation on Post-Market Surveillance: this area ensures there is a plan in place to maintain diligence past the production of the device to keep risk control measures safe.

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Think of your technical file as the DNA of your medical device. 

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How does a Technical File get your device a CE Marking?

Acquiring the CE marking on your medical device signals that the device is compliant with all European Union regulations and is cleared for market use. The CE marking process harmonizes product safety standards across the EU member states and facilitates the free movement of goods within the European Single Market. Which means you can think of that CE mark as a ticket to access to all EU countries with your product.

For all medical devices, obtaining a CE mark is not possible without a technical file. It signifies that a product meets the requirements outlined in the applicable EU directives or regulations, ensuring a high level of safety, performance, and quality. Most medical devices require a conformity assessment, which is an audit of your technical documentation and often your quality management system to ensure your product meets the requirements for a CE mark. If your medical device is of the lowest risk class, Class I, you can self-certify which does not require a conformity assessment.

The technical file is the primary file reviewed during a technical documentation conformity assessment. Auditors use it as a guide for your device and it is often the determining factor in whether a medical device receives a CE mark in the end. By providing an accurate and comprehensive technical file, you have less risk of auditors asking for more information about your device, delaying your regulatory approval time and risking your CE mark certification.

Having an accurate, complete, and easy to navigate technical file is paramount in creating a flawless conformity assessment and a smooth audit, delivering your CE mark on time and with minimal headaches.

FormlyAI: Your Partner in Medical Device Certification

At FormlyAI, we understand the complexities of MDR medical device certification. Our service provides a streamlined, efficient path to CE marking and all the tools to ensure your medical device adheres to all necessary EU regulations. All for a fraction of the cost of using traditional consultants. This way you can build your compliance documentation and apply for CE marking in a matter of weeks, not years.  

Learn more about our software and accelerate your path to CE marking with Formly.

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