Product Compliance
Prof. Dr. Handorn advises businesses in the medical devices area on all aspects of regulatory compliance, especially the implementation of the new EU regulatory package for medical devices and in-vitro diagnostics (Regulations (EU) 2017/745 and 2017/746). His clients include industry associations, universities and research institutions. Prof. Dr. Handorn specialises, at the interface to regulatory requirements for medical devices, in contract structuring in the supply and distribution chain and quality assurance agreements in the case of outsourced processes, including cooperation in own brand sales. He has special expertise in contract drafting in cross-border supply situations.

Product liability
Prof. Dr. Handorn advises companies comprehensively on the implementation of preventative safety correction actions in the field and provides support in communication with market surveillance authorities. In the event of claims, he advises and represents companies in defence of product liability claims and costs recovery in the supply chain.

Healthcare Compliance:
Professional dialogue between industry, doctors and health institutions is crucially significant for medical progress. Increasingly stringent compliance requirements in the healthcare sector must be observed in that process. Prof. Dr. Handorn advises companies on legally secure cooperation structures between healthcare professionals and medical institutions.

Research & Development
With the first qualifying product idea, the regulatory requirements for the later introduction to the market must be considered. Prof. Dr. Handorn supports companies, universities and research institutions in the design of research and development projects. That includes, in particular, advising on commercial and scientific tests and IIT (Investigator Initiated Trials) agreements.

• legal studies at the Freie Universität Berlin and industrial engineering studies at the Technische Universität, Berlin
• legal clerkship at the Kammergericht (Court of Appeal) and at the German General Consulate New York and at the Research Services of the German Federal Parliament; completion of doctorate.
• from 2005, lawyer at an international commercial law firm in international product liability and litigation. Specialisation on medical devices and pharmaceuticals.
• 2008 Secondment to the London office of a US law firm specialising in product liability
• from 2015, partner in an international commercial law firm in Life Sciences & Healthcare
• Honorary Professor for pharmaceuticals and medical devices law at the Ludwig-Maximilians-Universität Munich
• lecturer in the certificate course Medical Devices Regulatory Affairs at the University of Augsburg and member of the Scientific Advisory Board of the Research Centre for Medical Law at the University of Augsburg
• member of the working group “Law“ of the BVMed (Bundesverband Medizintechnologie)
• member of the German Society for Biomedical Engineering in the VDE (VDE DGBMT), Deputy Spokesman of the Regulatory Affairs Committee
• Prof. Dr. Handorn regularly lectures and publishes on current issues in medical devices law and medical devices and pharmaceutical liability.
• 2019 founding partner of the Produktkanzlei

Languages: German, English