The module on UDI/devices registration (second module) and the module on Notified Bodies and Certificates (third module) are available since October 2021 except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities. Afterwards, the remaining modules as well as the mechanism for scrutiny and the CECP will be released when EUDAMED is fully functional.
The new Medical Device Regulations MDR (EU) 2017/745 and IVDR (EU) 2017/746 introduce a Unique Device Identification (UDI) system for medical devices. Main provisions related to the establishment of the UDI system are contained in Chapter III and Annex VI of the two medical device Regulations. Overview of the MDR (EU) 2017/745 UDI and device data sets and IVDR (EU) 2017/746 UDI and device data sets to […]
Countries available in EUDAMED from December 2020 Which national competent authorities will be registered in EUDAMED Actor module from December 2020? As of December 2020, the national competent authorities from EU 27, Iceland, Liechtenstein and Norway will be registered in EUDAMED. Concerning other third countries national competent authorities, the Commission may in principle be able to register them in the actor module from a later […]
Every economic operator – EU and non-EU manufacturers, authorised representatives, system/procedure pack producers and importers) has to register as an actor in EUDAMED and provide the required information.
The Actor registration module enables economic operators to submit, by means of an actor registration request, the information necessary to obtain a single registration number (SRN). The SRN guarantees a EU-wide unique identification for economic operators (also outside of EUDAMED). Following the assessment and approval of the request by the concerned national competent authority, EUDAMED generates the SRN of the economic operator to the national […]
On 1st December 2020 the European Commission has made available the Actor Registration Module to Member States and economic operators. It is the first of six EUDAMED modules. Links are given below: EUDAMED restricted EUDAMED public The European Commission, in agreement with the Medical Device Coordination Group (MDCG), is going to make available the different modules on a gradual basis as soon as they are […]
Recent Comments