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Adverse Event Reporting

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Chris P Created:   Oct 12, 2022 Last commented:   Oct 20, 2022

Adverse Event Reporting

Hello

As a distributor of medical devices, if there is an adverse event, would I need to report it to the MHRA (we are UK based) or would that be the responsibility of the manufacturer?

thanks 

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Oct 13, 2022

In the case of an adverse event, you need to inform the manufacturer about it and then Manufacturer is responsible for reporting it to the MHRA. After that, your responsibility is to answer and be ready for any action that Manufacturer and/or competent authority will ask you.   

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Chris P Oct 19, 2022

Hello, thank you, that is what I thought.  I am just trying to make sure I have the policy correct.  

Could I also ask, if we have a partial own brand product, so the packaging has our company logo on. But we do nothing in the production process, and it is the manufacturers name and address on the packaging, and their CE Mark.  Would I follow the same process as above, or would I have to report to the MHRA under this scenario?

 

thanks

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Expert
Kristina Zvonar Brkić Oct 20, 2022

Yes, you can follow the same procedure. According to Article 16 from the MDR, if the CE mark of the manufacturer stays on the medical device, you do not consider a manufacturer, but rather the distributor.

1 a) makes available on the market a device under its name, registered trade name, or registered trademark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation.

For more information, see:

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Oct 12, 2022

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