Making a Submission: EU Medical Device Regulation (EU MDR)

The European Union (EU) Medical Devices Regulation (MDR) establishes a regulatory framework for medical devices that safeguards public health and safety while supporting the competitiveness of the market.

The Regulation (EU) 2017/745 aims to provide a consistent approach to ensure safe use and access for medical devices in the European Economic Area (EEA). The update to the Regulation (2017/745), under Chapter II of Annex I requires justification for use of substances potentially harmful to patients and end users. Materials with direct and indirect exposure to patients and end users may not contain 0.1% w/w of carcinogenic, mutagenic or toxic to reproduction (‘CMR’), of category 1A or 1B in addition to carcinogenic and toxic to reproduction, of category 2, in accordance with Part 3 of Annex VI from Regulation (EC) No 1272/2008 and substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health.

To comply with the very important Regulation, you are being asked to provide information on chemicals so your customer can continue to market and sell medical devices.

Once you receive the relevant campaign email, you can respond to the open request by selecting it from the Supplier Portal landing page.

  1. Before you begin, prepare the information you will need to complete your declaration and click Get Started:

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    From this window, you can download your Product List and Substance List for reference. These files download in Excel format. 

  2. On the main page, review the regulation details and the available Resources:

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    EU MDR Declaration Acceptance Criteria

  3. Use the checkboxes to select your product and click Declare for Selected:

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    You can declare for individual products or select in bulk. To display more products, open the drop-down menu on the bottom right of the table and select the desired number of items per page to display.

  4. On the next page, review the Product Details section:

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  5. If you have an IPC-1752A XML file to speed up the declaration process, click Upload File.

    Uploading a valid IPC-1752A XML will populate the corresponding sections below with the data contained in the XML. To continue declaring manually, skip to step 8

  6. Using the File Explorer, browse your organization's resources, attach the XML file, and click Open

  7. To continue declaring manually, click Next to expand the Product Statements section.

  8. Select a statement for your products and click Next:

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  9. In the Supporting Documentation section, click Upload.

  10. Using the File Explorer, browse your organization's resources, attach the desired file, and click Open

  11. Select a file type for the uploaded file from the drop-down list.

    To remove a document, click the “x”. You can upload multiple pieces of supporting documentation:
     
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  12. When you have uploaded your supporting documentation, click Next

  13. In the Substance Information section, click the Add Substance button:

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  14. In the Add Substance pane that opens, enter the required information marked in red and click Add:

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    Entering optional information can help your customer. You can also delete or edit any information entered here before completing the submission.

  15. Once you have finished adding your substance(s), review the entered information in the table:

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  16. Repeat this process for every substance you need to manually declare and click Next.

  17. In the Review section, the system will notify you if you are ready to submit your declaration:

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    If your customer has requested it, you may need to provide a Comment in this section. 

  18. Click Submit to finish and return to the main page.

  19. If necessary, repeat the declaration process for any remaining parts and click Done to submit your declaration(s). 

  20. On the Declaration Summary page, you can review the details and click Continue to finish:

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Have more questions? Submit a request

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