Webinar: Liability in MedTec - Liability in the medical device industry

Content

• Relevant areas of legal liability (criminal law, civil law, public law) and their consequences
• Obligations to avert danger and their relevance for liability
• Official prohibitions and claims
• Product liability towards users and operators
• Criminal offences, administrative offences
• Risk protection through risk management and contract design
• Liability under the German Drug Advertising Act and when outsourcing processes to third parties or drafting OEM contracts

Speaker profile:

Prof. Dr Boris Handorn specialises in providing comprehensive advice on medical device law, the drafting of supply and quality agreements in the life sciences sector and product liability law. In the area of product liability, he advises and represents companies in the coordination of product recalls and communication with authorities, in the defence of product liability claims and in the enforcement of recourse claims in the supply chain. He also specialises in drafting contracts for collaborations between life sciences companies and universities and research institutions.

• Product conformity
  • Prof. Dr Handorn advises companies in the medical technology sector on all questions of regulatory compliance, in particular on the implementation of the new EU legal framework for medical devices and in-vitro diagnostics. His clients also include associations, universities and research institutions. At the interface with the regulatory requirements for medical devices, he specialises in drafting contracts in the supply and distribution chain and in quality assurance agreements for outsourced processes, including cooperation in private label distribution. Prof Dr Handorn has particular expertise in drafting contracts for cross-border supply relationships.
• Product liability
  • Prof. Dr Handorn advises companies comprehensively on the implementation of preventive safety corrective measures in the field and supports them in their communication with market surveillance authorities. In the event of damage, he advises and represents companies in the defence against product liability claims and in the reimbursement of costs within the supply chain.
• Compliance in the healthcare sector
  • The professional dialogue between industry, doctors and healthcare facilities is essential for medical progress. At the same time, increasingly strict compliance requirements must be observed in the healthcare sector. Prof. Dr Handorn advises companies on the legally compliant structuring of collaborations with healthcare professionals and medical institutions.
• Research and development
  • Once the first qualified product idea has been developed, the regulatory requirements for subsequent market access must be taken into account. Prof Dr Handorn supports companies, universities and research institutions in the design of research and development projects. In particular, this includes advising on commercial and scientific clinical studies and IIT contracts.
• Career
  • Studied law at the Free University of Berlin and industrial engineering at the Technical University of Berlin
  • Job traineeship at the Higher Regional Court of Berlin with internships at the German Consulate General in New York and the Research Service of the German Bundestag; doctorate in law
  • Since 2005 lawyer in an international commercial law firm specialising in international product liability and litigation. Specialisation in the fields of medical devices and pharmaceuticals
  • 2008 secondment to the London office of a US law firm specialising in product liability
  • Since 2015 partner in an international commercial law firm specialising in life sciences and healthcare
  • Since 2016 lecturer and since 2024 honorary professor for pharmaceutical and medical device law at the Ludwig-Maximilians-University Munich
  • Lecturer in the certificate course "Medical Device Regulatory Affairs" at the University of Augsburg and member of the scientific advisory board of the Research Centre for Medical Device Law at the University of Augsburg
  • Member of the BVMed (German Medical Technology Association) legal working group
  • Member of the German Society for Biomedical Engineering in the VDE (VDE DGBMT), deputy spokesperson of the Regulatory Affairs Committee
  • Prof Dr Handorn regularly gives lectures and publishes on current topics of medical device law and medical device and pharmaceutical liability
  • Founding partner of the product law firm in 2019

Costs:

• €50 for biosaxony members
• €100 for non-members

The webinar will be held in English.

Register now and send an email to katja.krempler@leap-up.com!