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Product information questionnaire FOR PRODUCTS WHERE CE CERTIFICATION BY NOTIFIED BODY SGS ACCORDING TO REGULATION (EU) 2017/745 IS SOUGHT. This document should not be completed for devices that don't

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How to fill out notified bodies in form

01

Obtain the necessary form from the appropriate regulatory authority.

02

Fill in your company information accurately, including name, address, and contact details.

03

Provide detailed information about the medical device or product being submitted for approval.

04

Include any relevant testing or certification documentation with the form.

05

Review the completed form for accuracy and completeness before submission.

Who needs notified bodies in form?

01

Manufacturers of medical devices seeking approval for sale in certain regions such as the European Union.

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What is notified bodies in form?

Notified bodies in form are organizations designated by authorities to assess the conformity of certain products before being placed on the market.

Who is required to file notified bodies in form?

Manufacturers of products that require conformity assessment by a notified body are required to file notified bodies in form.

How to fill out notified bodies in form?

To fill out notified bodies in form, manufacturers need to provide information about the notified body they used for conformity assessment.

What is the purpose of notified bodies in form?

The purpose of notified bodies in form is to ensure that products meet the necessary requirements before being placed on the market.

What information must be reported on notified bodies in form?

Manufacturers must report the name and contact information of the notified body they used for conformity assessment.

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