Dr. Boris Handorn

Lawyer / Partner
lecturer at the Ludwig-Maximilians-Universität Munich

Dr. Boris Handorn

Dr. Boris Handorn specialises in comprehensive advice on medical devices law, drafting supply and quality assurance agreements in the Life Sciences sector and product liability law. In product liability law, he advises and represents companies on the coordination of recalls and communication with authorities, the defence of product liability claims and recovery of costs in the supply chain. He also specialises in contract drafting in cases of cooperation between Life Sciences companies, universities and research institutions.
Product Compliance
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. 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
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. 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. 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
  • since 2016, lecturer 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
  • 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
The complete list of Dr. Boris Handorn`s publications can be found here.  

Selected publications:
  • Die Medizinprodukte-Verordnung (EU) 2017/745 – ein Leitfaden für Wirtschaftsakteure zur MDR
  • Medizinprodukterecht – hier: Anspruch auf Information durch Übermittlung einer Kundenliste hinsichtlich bestimmter Hüftendoprothesen bejaht, Anmerkung zu OVG Münster, Urteil vom 19.11.2019 – 13 A 1326/17 (with Dr. Florian Niermeier), MPR 2020, p. 52 ff.
  • Arzneimittelhaftung, in: Kloesel/Cyran, herausgegeben von Prütting/Saalfrank/Stollmann/Wesser, Arzneimittelrecht – Kommentar, Loseblattwerk, ab 135. AktLfg 2019
  • Haftung für Arzneimittelschäden, in: Fuhrmann/Klein/Fleischfresser (Hrsg.), Arzneimittelrecht – Handbuch für die pharmazeutische Rechtspraxis, § 27, 2. Auflage 2014; 3. Auflage in Vorbereitung
  • Die Reform des Medizinprodukterechts in Deutschland und der EU, in: Spickhoff/Kossak/Kvit (Hrsg.), Aktuelle Fragen des Medizinrechts – Ein Ost-West-Vergleich, 2018, p. 93 ff.
  • Mitautor in: Prinz (Hrsg.), Entwicklung und Herstellung medizinischer Software, VDE-Schriftenreihe, Band 171, 2017; Development and Production of Medical Software, 2018 (eBook)
  • Mitbearbeiter in: Hill/Schmitt, WiKo – Kommentar zum Medizinprodukterecht, Loseblattkommentar (Art. 14, 15, 23 MDR) Medizinproduktehaftung – Die Technische Dokumentation im Rückruf- und Haftungsszenario, in: Capanni/Emmendörffer/Steffen
  • /Stockhardt (Hrsg.), CE-Routenplaner – Medizinprodukte planen, entwickeln, realisieren, Loseblattwerk und online Version
  • Liability for Medicinal Products and the Right to Disclosure under German Law (with Isabel Jakobs), European Pharmaceutical Law Review 3/2018, p. 155 ff.
  • Multiple Sklerose und Hepatitis-B-Impfung – Was bedeutet das Urteil des EuGH zur Haftung nach Impfung? (with M. Löbermann, A. Winkelmann et al.), Der Nervenarzt (10/2018), https://doi.org/10.1007/s00115-018-0492-6
  • Rili-BÄK in Altenheimen? (with Andreas Bietenbeck and Michael Pernus), Klinische Chemie Mitteilungen, 2017, p. 102 ff.
  • CE-Kennzeichnung eines Medizinproduktes, Anmerkung zu VGH Hessen, Beschluss vom 02.02.2017 - 6 B 2740/16 (with Jan C. Martin), MPR 2017, p. 89 f.
  • Das Fehlerrisiko bei Medizinprodukten als Produktfehler – Anwendung der EuGH-Rechtsprechung durch den BGH – Anmerkung zu BGH, Urteile vom 09.06.2015 – VI ZR 284/12 und VI ZR 327/12, MPR 2015, p. 207 ff.
  • Produkthaftung bei bloßem Fehlerverdacht?, PHi 2011, p. 206 ff.
  • Die "Pflegebetten"-Entscheidung des Bundesgerichtshofs – neue Leitlinien zur Kostentragung bei Produktrückrufen, MPR 2009, p. 37 ff.