This is what MT-CONNECT and MedTech Summit 2018 have to offer.
Clinical Investigation and Clinical Evaluation of Medical Devices from the Point of View of the Notified Body
Clinical Investigations and clinical evaluation of medical devices from the point of view of a notified body.
The collection of clinical data and their evaluation is an elementary aspect of the conformity assessment procedure for medical devices. The presentation refers to the requirements and clinical aspects that are manifested in the European Regulation for Medical Devices and the associated challenges for quality management systems, clinical evaluation procedures and reporting requirements for Manufacturers. It is evident that regulatory requirements for the manufacturer concern the entire life cycle of medical devices.
The equivalence procedure applied will no longer be possible. For product innovations, product changes and high-risk products therefore more clinical investigations prior to market authorization will be required and appropriate post market clinical follow up activities will be necessary after CE marking (PMCF).
The consultation procedure for the clinical evaluation of class III implants and class IIb medical devices (rule 12) has impact. The summary of safety and clinical performance as well as the periodic safety update report need regular updating during the post-marketing phase and will therefore introduce new tasks to manufacturers and notified bodies. In all these aspects, it is essential to ensure early and continuous planning for the systematic collection of clinical data in order to provide adequate and sufficient evidence for the ongoing confirmation of the clinical performance and safety of the medical device. Special attention during the collection of clinical evidence must be paid to any specific claims with regard to product characteristics. Clinical evaluations must be suitable to demonstrate that the device reflects state of the art with an overall acceptable benefit/risk ratio when used as intended.
--- Date: 12.04.2018 Time: 11:10 - 11:35 Location: Hall Brüssel 1, NCC Mitte