Preparing a technical file for a Class I medical device according to the European Union’s Medical Device Regulation (EU MDR) is a critical step in compliance for market access within the EU, thus The technical file, or technical documentation, provides evidence that your medical device meets the necessary regulatory requirements. Here’s a detailed guide on how to prepare this file:
1. Device Description and Specification
- General Description: Provide a detailed description of the medical device, including its intended use, principles of operation, and indications.
- Design and Manufacturing Information: Document the design stages, critical design elements, and the manufacturing process.
- Product Specifications: Include dimensions, materials, components, and any software involved.
2. Risk Management
- Risk Analysis: Conduct a thorough risk analysis to identify and assess potential risks associated with the device.
- Risk Management File: Maintain a risk management file in accordance with EN ISO 14971. This should include risk mitigation measures and residual risk evaluation.
3. Essential Requirements
- Compliance Checklist: Compile a checklist demonstrating conformity with all the essential requirements applicable to your device as outlined in Annex I of the EU MDR.
- Supporting Evidence: Provide supporting evidence for compliance, such as test reports, expert opinions, and relevant scientific literature.
4. Clinical Evaluation
- Clinical Evaluation Plan: Develop a plan detailing how clinical evaluation is conducted, following MEDDEV 2.7/1 rev 4 guidelines.
- Clinical Data: Provide data supporting the safety and performance of the device from clinical trials, if applicable, or justify why clinical trials are not necessary.
- Literature Review: Perform a systematic literature review of similar marketed devices to support safety and performance claims.
5. Post-Market Surveillance Plan
- Surveillance Strategy: Outline procedures and methodologies for ongoing surveillance after the product is placed on the market.
- PSUR: Prepare Periodic Safety Update Reports if applicable, to summarize findings from the post-market surveillance.
6. Labeling and Packaging
- Labeling: Ensure that labels include all necessary information, such as device name, instructions for use, warnings, and manufacturer’s details.
- Language Requirements: Verify that labeling and instructions for use are available in the official languages of the countries where the device will be marketed.
7. Declaration of Conformity
- Draft and Sign: Prepare and sign the Declaration of Conformity (DoC) stating that your device complies with the EU MDR.
8. Quality Management System
- QMS Documentation: Ensure that your quality management system, ideally compliant with ISO 13485, supports the design, manufacture, and distribution of your medical devices.
9. Notified Body Interaction (if applicable)
- Engagement Documentation: Though Class I devices are typically self-certified, some Class I devices (sterile, with measuring function) require a Notified Body assessment. Prepare documentation accordingly.
10. Registration
- EUDAMED: Register your device and your company in the European Databank on Medical Devices (EUDAMED).
This process requires meticulous documentation and adherence to regulatory requirements. It is also advisable to seek the expertise of consultants or legal experts specialized in EU medical device regulation to ensure thorough preparation and compliance.
Pacific Certifications is accredited by ABIS, in case you need support with Technical file preparation according to EU MDR for class one medical product, please contact us at suppport@pacificcert.com or +91-8595603096.
