Regulations (EU) 2017/745 and (EU) 2017/746 require the Commission to set up, maintain and manage Eudamed, which includes seven interconnected electronic systems. The development of four electronic systems has been completed and the completion of two further electronic systems is expected in 2024. However, the development of the electronic system on clinical investigations and performance studies has been significantly delayed due to the technical complexity of the requirements and workflows to be implemented.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.
