Special focus on IVDs
This year the implementation period of the MDR will pass the halfway point and the IVDR industry is getting to grips with the monumental change that the IVDR will entail. The first drafts of national implementing legislation are circulating so the post ‘date of application” picture under the MDR and IVDR is becoming clearer, which allows companies to finetune their implementation and transition programs. At the same time, the notified bodies are jockeying for MDR and IVDR certification and working on their Brexit plan Bs. The number of notified bodies applying for designation under the IVDR is lower than expected and many notified bodies may not be notified under the MDR. It is not at all certain that your notified body will be able to grant you an MDR or IVDR certificate in time.
This seminar will take stock of the implementation requirements under the MDR and IVDR , the main focus is on the IVD industry. Topics will include state of play with implementation of the MDR and IVDR at EU and Dutch level. The IVD specifics will include how to generate clinical performance data for IVDs, how to perform a performance evaluation to IVDR standards (some in development), additional essential safety and performance requirements and post market performance follow up requirements.