Dr Luc Van Hove from MARACA International has been invited to participate in the RAPS Netherlands Chapter meeting, which can only be attended by special invitation only.
Taking place on 9 February 2018 in Arnhem, MARACA will exchange ideas on the implementation of the new medical device regulations (MDR) and in-vitro diagnostic medical device regulation (IVDR).
In addition, the implementation acts and guidance will be reviewed, as well as the status of the notified body accreditations and transition will be discussed.
Other items of discussion include the future of MEDDEVs and common specifications, how to develop clinical evaluations for products under the MDR and IVDR, and what the post-market surveillance and risk management requirements will be under the new regulations.
There will be a lot of questions and MARACA will be the first to understand the best answers.