A Bottleneck for CE Certification
CE certification is and will continue to be essential to enter the European medical device market. However, the required re-designation of Notified Bodies under MDR / IVDR will lead to a reduction in the capacity for certification and a (temporary) limitation of the scope of the certification process of certain medical device classes.
The potential Notified Body deficit will lead to a temporary supply shortage of some medical devices and IVDs. Therefore, early contact with previously designated Notified Bodies, or Notified Bodies expected to be designated soon, under MDR / IVDR is key to avoid delay of certification / re-certification under the new regulations.
Kalms Consulting is in contact with several Notified Bodies and understands the documentation requirements and the interpretation of the regulations from their viewpoint. This change of perspective allows manufacturers to optimally prepare for MDR / IVDR certification.
Kalms Consulting provides guidance for the selection of newly designated Notified Bodies according to their scope for your (in-vitro diagnostic) medical device. We can also support you with the correct preparation of documents, thus increasing the chance to initiate the certification process. Wherever you are in the certification process, we support you with project management and translate missing essentials into correct documents required by the Notified Body.