Eudamed: new modules for medical device and notified body registration online
The progressive implementation of the web-based portal Eudamed – the European databank of medical devices provided for by Regulations (EU) 2017/745 and 2017/746 (MDR and IVDR, respectively) – is continuing.
As of October 2021, two further registration modules have been made available, along with module 1 already active regarding the registration of economic operators. The modules that have been released are the UDI/Devices module (2) and the Notified Bodies and Certificates module (3).
Economic Operators that have the SRN code can include the details of their medical devices that are present in the European market by a UDI unique code that is assigned to the medical device by a body (Issuing Entity) duly authorised by the Commission. The data will be divided into two sections: the UDI-DI, representing the device specifications and used as “access key” to all information stored in the UDI database, and the BASIC UDI-DI, containing all information regarding the actual device group, i.e. the family referred to in the relevant documentation. For this reason, more UDI-DIs can be generated for each Basic UDI-DI, but one UDI-DI should always be associated to one single Basic UDI-DI.
The inclusion of the data regarding medical devices currently occurs on a voluntary basis. It is possible to include reference that are in compliance with the MDR, but also with Directive EEC 93/42 (legacy devices). In such case, the inclusion is required to ensure active post marketing surveillance as well as the possibility of incident reporting.
On the other hand, module 3 regarding certificates and NBs has lower impact on manufacturers. Module 3 was made available in parallel with module 2 and will promote communications between notified bodies, in order to provide information on the summaries of safety and on the assessment reports by the same NBs. Information will be available on SCQ certificates and certificates of conformity, their framework and validity.
The release of the new modules confirms the European Commission’s will to make available a database system to economic operators and Members States, that is gradually taking its shape. Eudamed full functionality will in fact ensure an interconnected multifunctional system at European level, that will incorporate all aspects linked to a single medical device. The advantage of obtaining a SRN in advance is that it can be included in the relevant technical documentation with no need to update it at a second stage, ensuring for manufacturers a gradual adjustment to the Regulation.
Thanks to a team of experts in the field, Di Renzo Regulatory Affairs can assist economic operators in all the steps of the Eudamed registration, taking care of the SRN release phase, and supporting them in the performance of all activities in compliance with the MDR.
Written by: Sofia Tabacco
