Eliminate guesswork and ensure your Declaration of Conformity meets EU MDR expectations with a structured, ready-to-use template built for compliance.
The Declaration of Conformity is the manufacturer’s formal and legally binding statement that a medical device complies with all applicable requirements of Regulation (EU) 2017/745, as required under Article 19 and Annex IV. It is a mandatory document that must be established, maintained, and kept up to date throughout the device lifecycle. This template provides a comprehensive, regulator-aligned framework for preparing a Declaration of Conformity that accurately reflects the device’s compliance status. It incorporates all required elements, including device identification and UDI, applicable conformity assessment procedures, references to any common specifications in relation to which conformity is declared, and, where applicable, the notified body and authorised representative details.
Developed by experienced regulatory professionals, it provides a structured and efficient approach for manufacturers to formally declare conformity with applicable regulations.
Price: $100
