반응형
Introduction to the EUDAMED Workshop
The European Commission is organising a free registration hybrid workshop in Stuttgart to support the EUDAMED onboarding of all concerned actors, in view of the mandatory use of Actors, UDI/Devices, Notified bodies and Certificates and Market surveillance modules of the system. The workshop will provide an overview of the obligations under the Medical Devices Regulations (Regulation (EU) 2017/745 – MDR, and Regulation (EU) 2017/746 – IVDR) regarding EUDAMED and practical guidance on its use.
The workshop is a good opportunity for economic operators, notified bodies, national authorities, and other stakeholders to prepare for compliance with the Regulations in the context of EUDAMED.
In addition to this first session in Stuttgart, two other workshops with identical content will be held: on 8 October in Rome, Italy, and on 3 December in Brussels, Belgium. All workshops will also be available via online streaming for approved online participants. Please note that registration (both physical and online) for the workshops in Rome and Brussels will open at a later stage.
For the Stuttgart workshop, in order to ensure balanced geographical representation, physical participation will be prioritised for stakeholders based in Germany, Austria, Hungary, Poland, the Czech Republic, and Slovakia.
Below, you will find detailed information about the workshop, its objectives, and what participants can expect.
반응형