European Union Medical Device Regulation (MDR) Solution
The new EU MDR reveals major changes from the MDD, resulting in changes to your current quality management system (QMS). Our customizable MDR solution makes that an easy transition.
A Smarter Solution For Easy EU MDR Compliance
Automate your data collection with our EU MDR solution that can be tailored for your specific needs. Using AI technology, our platform is able to quickly gather supplier data, validate documentation, and compile the data into reports you need for easy EU MDR compliance. You can easily identify which products may contain substances of very high concern (Annex I of the MDR and IVDR) based on the current European Chemicals Agency (ECHA) listing.
Upload Your List of Suppliers
Identify Products that Contain SVHCs
Define the Smallest Level of an Article to Investigate
Quickly and Easily Pull Documentation and Reports
The deadline for EU MDR reporting is officially pushed to May 26, 2021.
What are the Compliance Requirements for EU MDR?
The new MDR requires that manufacturers report to the EUDAMED Database, which will be available for stockholders, consumers, and medical device companies. Each product will have labeling similar to the Unique Device Identifier (UDI) from the United States Food and Drug Administration (FDA). The regulation also requires that manufacturers implement or update their QMS, stating it must store documentation, conduct post-market surveillance, and assess risks. Medical devices are segmented into classes, ranked from Class I (low risk) to Class III (high risk). What class a product is in determines the extent of regulations it must be in compliance with.
Who is in Scope of EU MDR?
The goal of EU MDR is to make products more traceable. It includes a broader definition of “medical device” to include more products than the previous regulation. For example, the previous MDD did not include software as a medical device (SaMD), which is now a major component of the medical device market. Any companies that distribute medical devices in the European Union are in scope to comply with the EU MDR.