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.
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 […]
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