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Get Declaration Of Conformity. Medical Device Directive
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How to fill out the Declaration Of Conformity. Medical Device Directive online
Completing the Declaration Of Conformity is a crucial step for medical device manufacturers to demonstrate compliance with regulatory standards. This guide provides clear, step-by-step instructions to help you fill out this important document online.
Follow the steps to successfully complete your Declaration Of Conformity
- Click the ‘Get Form’ button to access the Declaration Of Conformity. Open it in your preferred editor.
- Enter the manufacturer's details in the designated section. This includes the name and address of the manufacturer, ensuring that it matches the official records.
- Fill in the product information. Specify the product name and model number as referenced, including details like 'API2 / MALT1 DNA-FISH Probe (Ref. 17-001)'.
- Indicate the compliance information. Reference the applicable directive document number and full title, such as '98/79/EC In Vitro Diagnostic Directive (IVDD)', along with the date of issue.
- Provide any additional required information, including conformity with relevant annexes, such as Annex I and III of the IVDD 98/79/EC.
- Ensure that the document is signed by an authorized representative, like the CEO or president, including their name and title.
- Finally, add the date of completion at the bottom of the form. Review all entered information for accuracy.
- Once all fields are filled, save your changes, and download, print, or share the completed Declaration Of Conformity as needed.
Complete your documents online to ensure compliance and streamline your process.
Contents of the Declaration of Conformity Name and business address of the product manufacturer or the authorised representative. Identification that allows the product's traceability. E.g. a serial or model number, or type identification. Notified body details, if applicable.
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