Developing the interface of the Estonian Medical Device Database to the European database on medical devices

Increased workload for the distributors and the Health Board

This would lead to the increase of distribution requests. As at the moment, data is inserted manually to the Medical Device Database, and there are many boxes to fill in for every device, it means the workload of distributors is quite high. It also means increased workload for the Health Board – managing requests takes time. The update integrates MSA with EUDAMED, which ensures the accuracy of the data and reduces the burden on all parties, as the data of the distributed device can be downloaded directly from EUDAMED.

This requirement is currently valid for higher risk devices (IIa, IIb, III and AIMD devices), but experience during the COVID-19 pandemic has also brought about the possibility of amending the law, which could also mean notifying the distribution of IVD devices and I risk devices (e.g., medical masks belong to risk class I and COVID-19 tests are IVD devices). However, this would bring about the manyfold increase of distribution requests.

The accuracy of data and automatic notification

As at the moment, data is inserted manually to the Medical Device Database, and there are many boxes to fill in for every device, it means the workload of distributors is quite high. It also means increased workload for the Health Board – managing requests takes time. The update integrates MSA with EUDAMED, which ensures the accuracy of the data and reduces the burden on all parties, as the data of the distributed device can be downloaded directly from EUDAMED.

As a result of the development, the Estonian Medical Device Database interacts with the European database on medical services  EUDAMED, resulting in more accurate data and a better overview of medical devices. The update will significantly reduce the administrative burden of the Estonian distributors, as the notification of distribution will become automatic.