Differences between EU MDR and US FDA regulations

Medical device regulation MDR 2017/745 is applicable to all medical devices that want to be placed on the EU market. Necessary Technical documentation is described in Annex 2 and Annex 3 of the MDR 2017/745.

Here are the links to that Annexes:

• EU MDR Annex 2 – Technical documentation - https://advisera.com/13485academy/mdr/technical-documentation/
• EU MDR Annex 3 – Technical documentation on post-market surveillance – https://advisera.com/13485academy/mdr/technical-documentation-on-post-market-surveillance/

A 510(k) is the technical dossier required by the US Food and Drug Administration (FDA) to sell a medium-risk medical device or IVD in the United States. It is formally called a Pre-market Notification. A 510(k) contains detailed technical, safety, and performance information about a medical device. The documentation must demonstrate the device in question is "substantially equivalent" to a predicate device (i.e. a product already cleared for sale in the US). The FDA must review the 510(k) and "clear" your device before you can legally sell or distribute it in the United States.

Here is the link to the content of the 510(k):

• Content of a 510(k) https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k
• Premarket Notification 510(k) https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k

Differences between MDR and FDA 510(k) are in some definitions, classes, and in the clinical investigation trials. Therefore, you can use our templates from our documentation toolkit. However, once again I repeat that this documentation is not all the required documents, and plans, reports, and results of different tests can not be standardized.