TÜV SÜD’s Clinical Center of Excellence has compiled a checklist to support medical device manufacturers in making complete and correct submissions of clinical evidence. This is one of the prerequisites for the Notified Body to run the review of the Clinical Evaluation Report (CER) and other relevant clinical documentation quickly and smoothly within the scope of conformity assessment (e.g. design dossier evaluation). The requirements for the CER and other relevant clinical evidence are set forth in the EU Directive and MEDDEV 2.7.1 “Clinical evaluation: a guide for manufacturers and Notified Bodies.”
Available free of charge, the new checklist helps medical device manufacturers to identify gaps in their clinical documentation – such as missing records – early and independently, and complete the documentation well in advance of the Review.
Effective immediately, the checklist is available for download as a PDF file: