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 will come into force officially in 2020, and will place restrictions and reporting requirements on substances used in the design and manufacturing process of medical devices, excluding IV medical devices, in order to reduce the potential risks posed by some 2,000 substances.
The EU MDR covers devices, parts of those devices, or materials used within those devices that are invasive and come into contact with the body; that administer or re-administer medicines, bodily fluids or other substances; and that are used to transport or store any such liquid.
Making an EU MDR Declaration in the Supplier Portal
Once you receive the relevant campaign email, you can make the declaration:
- Before you begin, prepare the information you will need to complete your declaration:
From this window, you can download your Product List and Substance List for reference. These files download in Excel format.
- On the main page, review the regulation details and the available regulation resources:
EU MDR Declaration Acceptance Criteria.
- Use the checkboxes to select your products and click Declare:
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 products to display (20, 40, 50, or 500):
To declare for all products, do not use the checkboxes, and click Declare for ALL (x).
- On the next page, review the Product Details section:
- 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 9.
- Using the File Explorer, browse your organization's resources, attach the XML file, and click Open.
- Click Next to expand the Product Statements section.
- Select a declaration statement for your products and click Next:
- In the Supporting Documentation section, click Upload:
- Using the File Explorer, browse your organization's resources, attach the desired file, and click Open.
- 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:
- When you have uploaded your supporting documentation, click Next.
- In the Substances section, click Add Substance:
- Enter the substance’s CAS or EC number to populate the desired search result:
- Check the box if the substance is Contained in product.
In Product: This substance is contained in the composition of the product in its final state (i.e. completed all manufacturing stages and ready for delivery/sale)
- Enter the Nominal Concentration of the substance.
Nominal Concentration is the value of mass when a single estimate value is provided.
- Select the Substance Status from the drop-down list:
- Enter where in the product the substance is found:
Describe the Sub-Product or Material in the Product where the Substance is found.
- To finish adding the substance, click Save.
- Repeat this process for every substance you need to declare and click Next:
- In the Review section, the system will notify you if you are ready to submit your declaration:
If your customer has requested it, you may need to provide a Comment in this section.
- Click Submit to finish and return to the main page.
- If necessary, repeat the declaration process for any remaining parts and click Done to submit your declaration(s).
- On the Declaration Summary page, you can review the details and click Continue to finish:
Making a Legacy EU MDR Declaration in the Supplier Portal
Once you receive the campaign email, you can complete the declaration.
- Review the regulation description:
- On the main page, click the checkbox(es) to select one or more parts and click Declare for # Selected Parts to declare for some parts, or Declare for All # Parts to declare for all possible parts:
- From the Select Declaration window, click Does Not Contain Substances or Contains Substances:
If you click Does Not Contain Substances, you are stating that the chosen part does not contain any of the substances in the substance list. Go directly to Step 12.
- On the Edit Substances window, click the column arrow to filter by Substance name, CAS number, Threshold or any of the available columns to find the desired substance(s).
- When you have found your substance, click the desired column to open the input and enter the substance information:
- Enter the Concentration % of the substance.
- In the Contained In field, enter where in the part the substance is contained (for example, paint, coating, wire jacket, etc.).
- To clear a row, click Clear.
- Repeat Steps #5-9 for each substance you need to add to the selected part(s).
- Once you have finished adding substances, click Next.
- On the Upload Supporting Documentation window, choose the type of supporting documentation you are uploading:
- Click the calendar icon to select the date the supporting documentation was created.
- Click Attach File to open the File Explorer and click Open to upload the appropriate document.
- You can upload multiple files using this window.
- When you have finished uploading your supporting documentation, click Ok.
- Upon returning to the main page, you will see a date under the Last Declared column for the selected part(s).
- Repeat the declaration process for any remaining parts.
- Click Continue to proceed to the optional Feedback page.