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Vol. 5, No. 16 Aug. 19, 2019IN THIS ISSUE FDA hits Houston device maker with lengthy warning letter.................... Page 3 Briefs: European Commission names third notified body for MDR TGA reviews

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Contact the appropriate notified body for your product category.

02

Submit an application for assessment and certification.

03

Provide all necessary documentation and information regarding your product.

04

Cooperate with the notified body during the evaluation process.

05

Implement any necessary changes or improvements based on the notified body's feedback.

06

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Who needs notified bodies have yet?

01

Manufacturers of medical devices, in vitro diagnostic devices, and other regulated products in the European Union.

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What is notified bodies have yet?

Notified bodies have yet to be designated under the new Medical Device Regulation (MDR) to conduct conformity assessments on medical devices.

Who is required to file notified bodies have yet?

Manufacturers of medical devices are required to work with notified bodies to have their products assessed.

How to fill out notified bodies have yet?

Manufacturers can request the services of a notified body to conduct conformity assessments on their medical devices.

What is the purpose of notified bodies have yet?

The purpose of notified bodies is to ensure that medical devices on the market meet the required standards for safety and performance.

What information must be reported on notified bodies have yet?

Manufacturers must provide detailed information about the design, manufacture, and intended use of their medical devices to the notified bodies.

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