Technical Documentation - Contents & Product Description

Ensure your medical device complies with Annex II of EU MDR 2017/745 by using our Product Description File and Technical Documentation Template. This comprehensive template provides a structured, detailed framework for compiling the required technical documentation, streamlining the process of regulatory submissions and compliance with the European Medical Device Regulation (MDR).

Key Features:

• Annex II Compliant: Fully aligned with Annex II of EU MDR 2017/745, ensuring that your technical documentation meets the mandatory requirements for device conformity and market access in the EU.
• Comprehensive Documentation: Includes referring to all essential sections for technical documentation, from device description and classification to design verification, risk management, and clinical evaluation, ensuring a complete regulatory submission.
• Product Description File: A dedicated section to thoroughly describe your device, including intended use, classification, variants, and device functionality, ensuring clarity and precision in regulatory submissions.
• Customizable: Easily adaptable to various types of medical devices including active and non-active, invasive and non-invasive, regardless of risk classification (Class I, IIa, IIb, or III), and tailored to the complexity of your device. 

Why Choose This Template?

• Regulatory Confidence: This template is structured to cover all the requirements outlined in Annex II of EU MDR 2017/745, ensuring that your device meets regulatory expectations for technical documentation.
• Save Time & Simplify Compliance: With predefined sections and guidance, this template significantly reduces the complexity of preparing technical documentation, saving time and resources.
• Adaptable to All Device Types: Whether your device is a low-risk Class I or a high-risk Class III, the template is flexible and customizable to meet the specific needs of any medical device.
• Audit-Ready Documentation: The template ensures that your documentation is well-organized and traceable, making it easy to present during audits or regulatory reviews.

What’s Included?

• Fully Editable Template in Word format: A customizable document that can be tailored to your device’s specific needs.
• Pre-Structured Sections: Covering all mandatory elements required under Annex II of EU MDR 2017/745.
• Guidance for Each Section: Clear instructions and examples to help you complete each part of the technical file accurately.
• Checklists & Traceability Matrix: Ensure that all documentation is linked to relevant evidence and meets regulatory requirements.

Comprehensive Compliance with Annex II of EU MDR

This Product Description File & Technical Documentation Template ensures you can systematically demonstrate the safety, performance, and regulatory conformity of your medical device, meeting the detailed requirements of Annex II of EU MDR 2017/745. Whether you are preparing for market entry, re-certification, or post-market updates, this template simplifies the process and ensures audit-ready documentation.