Clinical Evaluation requirements have increased dramatically since the release of MEDDEV 2.7.1 Rev 4 in 2016 and the MDR 2017/745 in May of 2017. The new regulations put a stronger emphasis on the link between the design and development process, post market surveillance, and risk management with consistency between all documentation required. All these changes require discussion by the cross-functional teams involved in these key roles to minimize duplication of work and ensure consistency across documentation.
What was once a somewhat solitary activity by a medical writer or regulatory representative now requires timely input concerning clinical performance specifications, side-effects, complaint trending and competitor analysis as depicted in the figure below. Post Market Clinical Follow-up is now an activity that updates the clinical evaluation, as stated in Annex XIV Part B of the MDR. Tasks can be split between post market surveillance teams and clinical evaluation teams. The output of clinical evaluation must then influence these processes. The MDR has also included timeline requirements for reporting on PMS activities that will influence the frequency of clinical evaluation. It is important to ensure that plans are in place to allow for reporting from each department with details on the information required as well as time for the cross-functional team to review and approve the clinical evaluation and make plans for any updates to PMS or risk documentation.
This free webinar will provide an overview of the types of data required for clinical evaluation from the design and development process, clinical investigations, post-market surveillance, post-market clinical follow-up, and risk management. This information provides a platform to determine the best approach for report delivery timelines and content that will make the clinical evaluation process more efficient.
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