New EU MDR Reporting Requirements Coming in 2020

New EU MDR Reporting Requirements Coming in 2020

Keeping up with the evolving compliance landscape can be challenging. From a growing list of labeling requirements to additional reporting criteria, companies must stay on top of compliance deadlines, or risk a variety of penalties. In 2017, an update to the European Union (EU) Medical Device Regulation (MDR) added yet another requirement: the European Database on Medical Devices (EUDAMED)

Under development for the European Commission by the Medical Device Coordination Group, EUDAMED is a tool for companies to report on products and make data available to member states. With completion delayed but slated for the first quarter of 2020, it is increasingly important that companies prepare to report on their products by the second quarter of 2020, or risk line of business disruption.

Updates to the EU MDR 2017/745 made uploading into EUDAMED part of the market approval process for products entering into the European Economic Area (EEA). Articles 33 and 34 of the EU MDR speak directly to EUDAMED and to suppliers’ requirements, highlighting EUDAMED’s future role as a repository for all products that move through the EEA. This update also changed the nature of market approvals, giving notified bodies a greater role in enforcement rather than treat them solely as a support mechanism for manufacturers to obtain market approvals.

Existing products that were approved to be placed on the EEA market before the deployment of EUDAMED will not have to report into the database until their certification expires. However, all renewals will have to go through the database. Though the data required for EUDAMED is not yet finalized, it may include:

  • Details about the manufacturer and authorizing representative.
  • Device information, such as certificate number and status.
  • Where the device is being sold, and lot and serial number.
  • Any clinical investigations undertaken on the product.

Download our eBook, Understanding the European Union Medical Device Regulation, for a comprehensive analysis of the EU MDR from Assent’s subject matter experts.

There are many projected benefits to a centralized database in the EU. Once product data is verified, the competent authority will provide a registration number (SRN) to that manufacturer, representative or importer, making it easier to track products. This single centralized database also supports post-market surveillance, and enables the sharing of data across the EEA and globally, though it’s important to note that registration does not certify compliance in all regions, only those affected by the EU MDR. Finally, with the turn toward consumer visibility, the database allows the public to see data relating to the products they use, enabling them to make more informed decisions.   

The Assent Compliance Platform allows companies to efficiently collect, manage and analyze supply chain data from a single location. Our Chemical Reporting Module, part of the platform, automates the EU MDR data collection and management process.

To learn more about how Assent can help you meet your requirements under the EU MDR, contact us at