Impact of Eudamed For manufacturers, the introduction of Eudamed will simplify both post-market s

Impact of Eudamed

For manufacturers, the introduction of Eudamed will simplify both post-market surveillance and notification procedures. For example, in-vitro diagnostic (IVD) manufacturers marketing within the European Union currently are required to separately notify each Competent Authority in every market in which their products are sold. In a less onerous approach, Class IIa, Class IIb and Class III manufacturers only must notify a Competent Authority if that member state in their transposition of the Medical Device Directive 93/42/EEC required notification. In contrast, device manufacturers of Class I devices only must notify the Competent Authority in the country in which they are based (or their Authorized Representative is based). Thus, the introduction of Eudamed will impact manufacturers, particularly IVD manufacturers, that will no longer be required to notify each Competent Authority separately if they intend to market their product there.

Another likely outcome of the implementation of Eudamed and a single, unified databank is the reduction of risks due to known device-related incidents or malfunctions that have occurred in other markets. To clarify, at present without a shared databank, a time lag exists in the communication of device-related issues to the appropriate regulatory body in multiple markets. With the use of Eudamed, notification efforts will be streamlined, resulting in a more timely and efficient process, thus reducing the risk of repeat issues. It is envisioned that Eudamed will facilitate reporting of Field Safety Corrective Actions as well.