Regulatory documentation writing

Centaur Clinical can draft regulatory documentation and submit them to Notified Bodies or regulatory agencies/ethics committees (for example: informed consent and protocol):

The clinical evaluation report

We analyse pre-clinical and clinical data of your MD and constitute the final document to be submitted to the notifying body. Our expertise in the submission of regulatory dossiers, the conduct of tests and trials enables us to offer you a relevant analysis that complies with the guidelines from the MEDDEV 2.7 rev. 4 directive and thus we facilitate the communications with the notifying body.

The IVD performance evaluation report

The 2017/746 Regulation on in vitro diagnostic medical devices (IVD) considerably changes certain key aspects of the previous regulatory approach. In regards to the CE marking process, it is essential to validate the claims that has been proposed by the manufacturer, based on clinical evidence. This validation, which is carried out by a clinical trial and follows the same protocol as for MDs, will form an integral part of the CE marking technical dossier.