active implants

Active Medical Implants

"Active Implantable Medical Device" means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.

Services offered by Medical and Health Services (Department "Active Medical Implants"):

• EC Conformity Assessment Procedures for Active Implantable
  Medical Systems in accordance with the Active Implantable Medical Devices Directive - AIMDD 90/385/EEC
  

• Reviews, including reviews subject to a subcontracting process, for biocompatibility, sterility, electrical safety, mechanical safety and functional safety, including software and electromagnetic compatibility, ionizing radiation and non-ionizing radiation, performance parameters, environmental and disposal aspects and clinical assessment for active implantable systems

• Assessment and compliance with requirements of the Radio & Telecommunications Terminal Device Directive (R&TTE) in connection with active implantable systems (AIMDD - R&TTE)

• Assessment of aspects in the application of TELEMEDICINE in connection with active implantable systems

• Collaboration in international approvals/licensing, access to important markets e.g. TGA (Australia), CMDCAS (Canada)

• Expert opinions and evidence relating to harmlessness in terms of technical safety according to the Medical Products Law (MPG)

• Cooperation with clinical users in processing special issues relating to the user ordinance (MPBetreibV) for active implantable medical systems

• Cooperation with national authorities in the field of medical products in processing special issues relating to the safety plan ordinance (MPSV) for active implantable medical systems

• Review of special productions and components of active implantable medical systems from "in-house production"

• Review of special designs related to micro- and nanotechnologies of active implantable medical systems from research projects

• Active implantable medical device systems
  

(Systems generally consist of implantable and external components like e.g. programming devices, stimulus threshold analyzers, software, etc.)