Step-by-Step Instructions:
1. Requirements and Authorisation for Product Registration:
- Authorisation: The rights for product registration are transferred by the Manufacturers or LAA to authorised persons. The LAA can only be authorised via a second account.
- Start registration: Go to the „Tasks“ tab and click on „Register a new Basic UDI-DI“.
2. Select Product Type:
- In vitro diagnostic devices (IVDs) or medical devices (MDs): The process will be demonstrated using a medical device.
3. Enter Basic UDI-DI Information:
- Designated Allocation Body: Select an allocation body (GS1, HIBCC, ICCBBA, IFA GmbH).
- UDI-DI generation: Use the respective generator of the allocation body.
4. Enter Product Information:
- Product category: Select the appropriate product category.
- Risk class: Enter the risk class of the product and answer the corresponding questions.
5. Identification Numbers and Codes:
- UDI-DI Code: Enter the 14-digit code (for GS1, simply place a zero in front of the 13-digit code).
- EMDN-Code: Select the appropriate code from the EMDN database.
6. Enter Product Details:
- Trade name and language: Enter the name of the product and the language.
- Sales information: Specify whether the product is marketed directly, and which sales unit is used.
7. Product Identifier (UDI-PI):
- Information: Select the information to be included in the UDI-PI (lot/batch number, serial number, production date).
8. Market Entry:
- Market entry: Specify whether the product is already on the market or is to be launched on the market.
9. Additional Product Information:
- Product size and form: Relevant information for clinical trials.
- Special requirements: Indicate any temperature sensitivity or moisture sensitivity.
- Warnings and contraindications: Indicate optionally.
10. Finalise the Registration:
- Check: Check all data entered for errors.
- Save and submit: Save or submit the registration.
We hope that we have been able to assist you with this product registration tutorial.
Please do not hesitate to contact us should you require further clarification.
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