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Angela Graf

Lawyer / Master of Health and Medical Management / Speech therapist (univ.)
Dr. Fandrich Rechtsanwälte (Bonn, Deutschland)
Germany

Dr. Graf has specialized in the life sciences and healthcare sector for many years. After working for Pharma Deutschland e.V. and a law firm specializing in medical device law, she now works for Dr. Fandrich Rechtsanwälte in Bonn. There, she advises and represents pharmaceutical companies, medical technology manufacturers, research companies, and service providers. One of her main areas of expertise is medical device law. Dr. Graf knows medical device law “from the ground up.” Thanks to her intensive professional support and practical application of this complex area of law, which has undergone fundamental changes in recent years, she is a competent representative in dealings with notified bodies, authorities, and in court. Dr. Graf is co-editor of the commentary “Praxis Medizinproduktrecht” (TÜV Media GmbH) and author of numerous specialist articles on medical device law, including in the “Praxishandbuch Medizinproduktrecht” (Beck Verlag). She is head of the “Pharmaceutical Law” and “Medical Devices” modules in the “Master of Drug Regulatory Affairs” (MDRA) program at the University of Bonn, lecturer in the postgraduate program “Toxicology and Environmental Protection” at the University of Leipzig, and a sought-after speaker at numerous events on medical device law. Dr. Graf was awarded the Science Prize for Medical Device Law in 2017.

Topics

Evidence generation in post market phase

Clinical Evidence Generation
Different Types of Studies
5.2.2026 15:20 - 16:00 | Hall 209

Clinical evaluation is the “heart” of the technical documentation for a medical device. Its basis: clinical data. To keep this data up to date, manufacturers must continue to collect data throughout the entire life cycle. But in what legal context can this be done? The aim of this presentation is to provide an overview of post-market clinical follow-up (PMCF) and to highlight practical case scenarios: When is it a “real” clinical investigation in the regulatory sense with the associated requirements (involvement of competent authority and/or ethics committee)? How should registry studies be handled, and can surveys also be a clinical investigation? The presentation will provide answers to these practically relevant questions.