Glossary Term
Technical File (EU MDR)
Definition
A Technical File is a comprehensive set of documentation required by the European Medical Device Regulation (EU MDR) for the approval, market access, and ongoing compliance of medical devices within the European Union (EU). The Technical File provides evidence that a medical device meets all relevant regulatory requirements, including safety and performance standards, before it can be marketed in the EU. It typically includes product specifications, design and manufacturing information, risk management files, clinical evaluation data, and performance testing results. The file is intended for review by regulatory authorities, notified bodies, and other stakeholders to ensure that the device complies with the EU MDR's stringent requirements.
Relevance to the MedTech Industry
In the EU, the Technical File is a crucial component for demonstrating regulatory compliance, ensuring the safety and effectiveness of medical devices before they are placed on the market. The EU MDR, which came into force in 2017, significantly strengthened the regulatory requirements for medical devices, making the Technical File an essential part of the product lifecycle. Manufacturers must maintain and update the Technical File throughout the product’s lifecycle to reflect changes in design, materials, or clinical data. This document is not only vital for the initial approval of a device but also plays an ongoing role in post-market surveillance, ensuring that devices continue to meet EU safety standards after they are sold.
Additional Information & Related Terms
Key Features of a Technical File
Device Description and Specifications:The Technical File must contain a detailed description of the device, including its intended use, indications, contraindications, and features. It also includes specifications such as design details, materials, and components used.
Risk Management:The Technical File includes a comprehensive risk management file that identifies potential hazards, assesses their risks, and details the steps taken to mitigate these risks. This is a requirement under the EU MDR to ensure patient safety.
Clinical Evaluation:The file includes clinical evaluation reports that assess the clinical evidence for the device’s safety and performance. This can include clinical trial data, literature reviews, or other forms of evidence that demonstrate the device meets the intended clinical needs.
Design and Manufacturing Information:This section includes detailed records of the design process, manufacturing procedures, quality control measures, and any changes to the product design over time. It ensures that the product is manufactured consistently to meet specifications.
Compliance with EU MDR Requirements:The Technical File must demonstrate how the device meets the essential requirements of the EU MDR. This includes safety, performance, labeling, and clinical evidence requirements. It also must include any necessary declarations of conformity.
Post-Market Surveillance and Vigilance:Manufacturers must include a plan for post-market surveillance, which monitors the performance of the device once it is in the market. This section also includes a process for reporting adverse events and recalls as required by the EU MDR.
Related Terms
CE Marking: The certification mark that a medical device must obtain before being sold in the European Union, indicating compliance with EU MDR.
EU MDR (European Medical Device Regulation): The regulation that outlines the requirements for medical devices marketed in the EU, including safety, performance, and regulatory documentation.
Clinical Evaluation Report (CER): A report that evaluates the clinical data for a medical device to ensure its safety and performance, often included in the Technical File.
Declaration of Conformity: A document that confirms a product complies with the applicable regulations and requirements for marketing in the EU, including the EU MDR.
Notified Body: An independent organization that evaluates the conformity of medical devices with EU regulations and provides certification for CE marking.