Clinical investigations of medical devices

This branch covers device clinical investigations, divided by the work involved in development, planning, connected documentation, reporting and registration. Drug trials, participant-facing consent materials, clinical evaluation and post-market clinical follow-up sit outside this branch.

• How a medical device is developed and tested — development from clinical need to pivotal study, preclinical work, investigation designs and studies for certification and market access
• Clinical investigation plans for medical devices — device-study differences, standards and regulations, drafting the plan, design, conduct, ethics and safety provisions
• The documents a device investigation draws on and feeds — the investigation’s own documents and their connections with clinical evaluation, post-market, risk, labelling and public documents
• Clinical investigation reports for medical devices — standards, timing, review, distribution, public availability, drafting inputs, report sections and writing effort
• Registering a device investigation while Eudamed is delayed — disclosure duties, transitional provisions, prospective registration choices, available registries and preparation for public disclosure