The new EU MDR 2017/745 is complex, to say the least. Depending on a company’s relationship to the medical device the regulation may give them more responsibility or it may give them less. Some general responsibilities apply to everyone regardless of the relationship to the medical device. Parties like distributors and importers though have specific obligations that they must meet in order for them, and the device, to be compliant. Check out this blog to learn more about the obligations of distributors. Even compared with distributors, importers have much more detailed obligations outlined in the EU MDR.
First, it is important to understand exactly who is considered an importer according to the regulation. The EU MDR defines importers as “any natural or legal person established in the EU that places a device from a third country on the EU market.”[1] Knowing what it means to be an importer will help to establish who is required to meet the obligations for importers set in the regulation.
In a similar manner to both manufacturers and distributors, importers are obligated to do checks of the device to ensure compliance. The importer must check both the label of the device and the registration of the device.1 Part of the registration check involves checking for the CE mark on the device. This is the obligation of multiple parties in the EU MDR in order to set up multiple checks and attempt to prevent any possible mistakes from being made.
Importers have one key difference in obligations from distributors, importers are required to name themselves on the device. The importer must place their name and information on the label, the packaging, or an accompanying document.1 This is required because importers are ultimately the ones placing the device on the market, so their information is crucial for tracking and reporting purposes.
It is important to note, that in some cases the manufacturer, distributor, and importer may all be the same company. In which case, the company would be required to fill the obligations of all three parties. However, this is not always the case and sometimes a company may only play one or two of the roles. Understanding roles in regulations can be difficult, understanding roles in recently changed regulations is even more so. EMMA International can help understand the responsibilities your company has in relation to a product. On top of that, EMMA International can provide assistance with meeting those obligations. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.
[1] The European Union Medical Device Regulation (November 2021) Importers, Retrieved 01/22/2022 from https://eumdr.com/importers
