Important Updates on EUDAMED and Economic Operator Responsibilities!

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The European Commission released some updates regarding EUDAMED, the European Database on Medical Devices. These updates pertain to the responsibilities of economic operators.

The update on the EUDAMED – release notes, section 2.1, reflects Article 31 §5 from MDR (EU) 2017/745 and Article 28 §5 from IVDR (EU) 2017/746:

Not later than one year after submission of the information in accordance with paragraph 1, and every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its territory until that economic operator complies with that obligation.

Additionally, it is crucial for all manufacturers to note the requirements stated in Article 31 §4 from MDR (EU) 2017/745 and Article 28 §4 from IVDR (EU) 2017/746:

Within one week of any change occurring in relation to the information referred to in paragraph 1 of this Article, the economic operator shall update the data in the electronic system referred to in Article 30.

For a detailed step-by-step explanation, we highly recommend referring to the video in section 2.1.7 of the Economic Operators – user guide, which provides a comprehensive guide. To access the video, click here.

Should you have any further questions or require additional information, please do not hesitate to reach out to us.

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