Declaration of Conformity Template - MDR 2017/745
Declaration of Conformity Template - MDR 2017/745
Template Overview
Template Overview
Streamline your EU Medical Device Regulation (MDR) 2017/745 compliance with our Declaration of Conformity (DoC) Template. The Declaration of Conformity is a legally required document that manufacturers must issue to confirm their medical device meets all applicable regulatory requirements before placing it on the EU market.
Key Features
Key Features
✔ Pre-Formatted DoC Template – Covers all required elements under MDR Article 19 & Annex IV.
✔ Manufacturer & Product Identification Sections – Clearly document key details.
✔ Applicable EU Legislation & Standards – Reference MDR 2017/745 and relevant harmonized standards.
✔ Notified Body Information Section (if applicable) – Ensure compliance for Class Is, Im, Ir, IIa, IIb, and III devices.
✔ Legal Manufacturer’s Signature & Declaration Statement – Meet regulatory obligations.
✔ Editable Digital Format – Fully customizable for different medical device classifications.
Why choose a QMS Template?
Why choose a QMS Template?
This user-friendly template provides a structured and compliant format, helping manufacturers, regulatory teams, and quality managers create a fully compliant MDR Declaration of Conformity with ease.
Ensure your medical devices are ready for EU market approval – download our MDR Declaration of Conformity Template today!
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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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For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.