Medical Devices Law – Fields of Competence:

Subject of the medical devices law are all contents anchored in the German Medical Devices Act. Due to European legislation harmonization and the reference to directives, the European medical devices law - including the guidelines - is of great importance as well. Special ordinances (e.g. MPV, MPBetreibV, MPSV, MPKPV) complement the German medical devices law. In addition to those, the provisions of the German Act on Medication Advertising have to be obeyed. In the area of reimbursement, the SGB V is decisive for the economic success of a company.

Fields of Competence:

• Medical devices law counseling
  
  • Conformity assessment
  • Clinical trials
  • Reprocessing of medical devices
  • Questions of Distribution
• Accompaniment in discussions with authorities
  
  • Legal issues concerning authorizations or certifications
  • Medical devices expertise to reinforce argumentations towards authorities
• Contract negotiations assistance
  
  • Outsourcing
  • Agreement of the division of responsibilities
  • Distribution
  • Cooperations
  • Investigators' contracts
  • CRO contracts
• Development of strategies
  
  • Reviewing of marketing strategies
  • Reviewing of cooperations
• Reimbursement of medical devices in the Statutory Health Insurance (SHI)
• Medical devices liability
• Medical devices crime law, anti-corruption legislation, compliance