Get the free Notification of Medical Devices and In vitro Diagnostics - BfArM
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Engage 1 (EU 4 Abs. 1 NR. 1 DIM DIV) Formularnummer 00304828Allgemeine Anzeigepflicht each 25 UND 30 Abs. 2 MPG General Obligation to Notify pursuant to 25 and 30 (2) Medical Devices Act, MPG Formulate
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How to fill out notification of medical devices
How to fill out notification of medical devices
01
Fill out the required information on the notification form, including the name and address of the manufacturer, product description, intended use, and classification of the medical device.
02
Attach any necessary supporting documentation, such as technical specifications or test reports.
03
Submit the completed notification form and supporting documents to the appropriate regulatory authority responsible for medical devices in your country.
Who needs notification of medical devices?
01
Manufacturers of medical devices that are seeking to distribute their products in the market.
02
Importers or distributors of medical devices that are bringing products into a country for sale or distribution.
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What is notification of medical devices?
Notification of medical devices is the process of informing regulatory authorities about the details of a medical device before it can be marketed or used.
Who is required to file notification of medical devices?
Manufacturers, importers, and distributors of medical devices are required to file notification of medical devices.
How to fill out notification of medical devices?
Notification of medical devices can be filled out by providing detailed information about the device, its intended use, and any potential risks or side effects.
What is the purpose of notification of medical devices?
The purpose of notification of medical devices is to ensure the safety and effectiveness of medical devices on the market for patient use.
What information must be reported on notification of medical devices?
Information that must be reported on notification of medical devices includes device specifications, intended use, manufacturing information, and risk assessment.
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