Get Fsca Report Form

This guide provides clear instructions on completing the Fsca Report Form online. Whether you are submitting your first report or a follow-up, these steps will help ensure all necessary information is accurately entered.

Follow the steps to successfully complete the Fsca Report Form online.

1. Click ‘Get Form’ button to obtain the form and open it for editing.
2. In the 'Administrative information' section, specify the national competent authority you are sending the report to. Select the type of report: initial, follow-up, or final, and fill in the date, reference numbers related to the manufacturer and NCA, and the name of the coordinating NCA, if applicable.
3. Go to the 'Information on submitter of the report' section. Indicate the status of the submitter by selecting the appropriate option (manufacturer, authorized representative within EEA and Switzerland, or others). Provide any necessary identification for other roles.
4. In the 'Manufacturer information' section, enter the manufacturer’s name, contact person's name, address, postcode, city, phone number, fax, email, and country.
5. If applicable, complete the 'Authorised Representative Information' section with the same details required for the manufacturer.
6. Fill in the 'National contact point information' by providing the name of the national contact point, the contact person's name, their address, postcode, city, phone number, fax, email, and country.
7. Complete the 'Medical device information' section. Select the corresponding device class from the provided options, fill in the nomenclature system, nomenclature code and text, commercial name, model number, catalogue number, serial numbers, lot numbers, manufacturing date, and expiry date. Provide the notified body ID number if necessary and details about associated devices or software versions.
8. In the 'Description of the FSCA' section, enter background information about the FSCA, describe and justify the corrective or preventive action, state advice for distributors and users, and include a progress report with reconciliation data if this is a final FSCA. Provide a time schedule for the implementation of actions.
9. Attach any necessary documents listed at the end of the descriptions, such as the Field Safety Notice in English, in the national language, or any other relevant attachments.
10. Send any comments or additional information as needed in the 'Comments' section, affirming that the information provided is accurate to the best of your knowledge.
11. Once all fields are completed, save any changes, and choose to download, print, or share the completed form as needed.

Start filling out your Fsca Report Form online today!