Technical File Template - MDR (EU MDR 2017/745)
Technical File Template - MDR (EU MDR 2017/745)
Template Overview
Template Overview
Ensure your medical devices meet the stringent requirements of EU Medical Device Regulation (MDR) 2017/745 with our Technical File Template. The Technical Documentation is a mandatory requirement for market approval, proving compliance with General Safety and Performance Requirements (GSPR) and other MDR obligations. Our structured template simplifies the process, helping manufacturers efficiently compile and organize all necessary documentation.
Key Features
Key Features
✔ Pre-Formatted Technical File Structure – Covers all Annex II & III MDR requirements.
✔ Device Description & Intended Purpose – Clearly document product specifications.
✔ GSPR Compliance Section – Align with Annex I requirements.
✔ Risk Management & Clinical Evaluation Sections – Integrate ISO 14971 and clinical data.
✔ Manufacturing & Quality System Documentation – Demonstrate ISO 13485 compliance.
✔ Labeling & UDI Compliance Sections – Ensure adherence to EU labeling regulations.
✔ Editable Digital Format – Fully customizable for different device classifications.
Why choose a QMS Template?
Why choose a QMS Template?
Designed for manufacturers, regulatory teams, and consultants, this MDR Technical File Template saves time, ensures consistency, and helps create audit-ready documentation for EU market approval.
Download the EU MDR Technical File Template today and simplify your path to compliance and certification!
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Additional information
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About Patient Guard
QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.
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Contact Us
For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.