Clinical evidence plays a crucial role in the conformity assessment procedure for medical devices. Without sufficient clinical data demonstrating safety, clinical performance, and clinical benefit, obtaining approval in Europe is nearly impossible.
This seminar provides you with the fundamental requirements of European regulations, the MDR, laws, and guidelines for clinical evaluation, and their implementation within the conformity assessment procedure for medical devices. It also covers updates throughout the entire product lifecycle.
Topics include the general process of clinical evaluation and the required contents of key documents such as the Clinical Evaluation Plan and Clinical Evaluation Report. Emphasis is placed on the clinical evaluation requirements from the Medical Device Regulation (2017/745, MDR). The importance of clinical evaluation in the Post-Market Surveillance (PMS) phase, including Post-Market Clinical Follow-up (PMCF), is also discussed.
Importance and types of clinical data for approval and marketing of medical devicesClinical evaluation requirements under European medical device lawLiterature research and reviewProcess and documentation of clinical evaluation according to MDR and relevant guidelinesContents and preparation of Clinical Evaluation Plans and Clinical Evaluation ReportsData identification, assessment, analysis, and developing a clinical strategy to determine the clinical evaluation routeQualifications of author/reviewer teamsDecision criteria for clinical evaluation routesAssessment of equivalence to other productsBenefit-risk evaluationState-of-the-art assessmentSummary report on clinical performance and safetyInterface with risk analysis in evaluating clinical dataClinical evaluation within the Quality Management systemWeighing the necessity of clinical investigations for conformity assessment proceduresInterface with the Post-Market Surveillance systemUpdating clinical evaluations and linking to the PMS systemWhen are PMCF studies required?
Gain expertise in identifying and providing required clinical data for medical devices.Successfully perform clinical evaluations of your medical devices.Implement regulatory requirements and meet official demands regarding clinical evaluation.
Employees in Regulatory Affairs and Quality AssuranceStaff in Research and Development, Clinical AffairsEmployees in Product Management and MarketingEmployees from regulatory authorities
For advanced knowledge, we recommend the follow-up seminar: Clinical Evaluation – Advanced Course (4611079).This seminar is part of a modular training program. Upon successful completion of advanced modules, you can earn the recognized certification:Manager Clinical Affairs – TÜV
The seminar covers internationally valid standards and is suitable for international delivery.The seminar fee includes the professional reference book "Medical Device Regulation (MDR)".
Participants receive a certificate of attendance from TÜV SÜD Academy.
This training is being operated by TÜV SÜD Akademie GmbH in Germany. The General Terms and Conditions as well as the Privacy Notice of TÜV SÜD Akademie GmbH apply. In case of any questions, do not hesitate to contact us.
