DIMDI - Medical Devices - Links

List of Links

The link list provides relevant links to webpages of authorities, organisations, institutions and asscociations that pertaining to the entire field of medical devices. The list is not exhaustive in the areas specified.

BMG - Department

• Federal Ministry of Health (BMG)
  BMG is responsible for the legal foundations for the protection of human health, provided they do not come under the state's line of duty.
• Federal Institute for Drugs and Medical Devices (BfArM)
  The authorisation of medicinal products, registration of homeopathic drugs, evaluation of the side effects of drugs and medical devices, as well as legal traffic control of narcotics are some of the main tasks of BfArM.
• Paul-Ehrlich-Institute (PEI), Federal Institute for Vaccines and Biomedicines
  PEI is responsible for the authorisation and regular inspections of vaccines, sera, immune diagnostics, products derived from human blood or plasma, as well as the risk evaluation of in vitro diagnostics.

Organisations, Institutions, Associations

• German Institute for Standardisation e.V. (DIN)
  Since 1975 DIN has been recognized by the German government as the national standards body and represents German interests at international and European level.
• German Medical Technology Association e.V. (BVMed)
  The German Medical Technology Association (BVMed), a trade association from the medical device industry domain.
• European Commission - Consumer Affairs - Medical Devices
  Information on legislation, directives etc. concerning medical devices
• European Diagnostic Manufacturers Association (EDMA)
  EDMA represents the European in vitro diagnostics/medical laboratory tests industry. You can request information on the EDMS classification.
• emtec e.V.
  A non-profit Institute for Scientific Counselling and Advanced Training in Medical Technology.
• European Confederation of Medical Devices Associations (EUCOMED)
  EUCOMED represents manufacturers and associations in the field of medical devices troughout Europe.
• U.S. Food and Drug Administration (FDA)
  The FDA is an U.S. American organisation of public health working for consumer protection in the field of foods, cosmetics, drugs, medical devices etc. Medical Device Reporting (MDR) and Recall Reports are issued on medical devices.
• Global Harmonization Task Force (GHTF)
  The Global Harmonization Task Force (GHTF) is a world-wide collaboration of regulatory authorities and industry with the objective to harmonise the regulations in the medical device field.
• Association of the Diagnostics Industry (VDGH)
  VDGH is a trade association of corporations from the field of laboratory diagnostics.
• Working Committee for Medical Technology Berlin-Brandenburg (AMBB)
  Open Working Committee of medical technology specialists.

Producers of Nomenclatures and Catalogues for Medical Devices

• HOSPIMED Informations-Datenbanken
  Information systems for companies on the subjects medical technology, services and facilities, laboratory and chemical analysis, rehabilitation, nursing and medical devices.
• Seibt Industrie-Informationen
  Information on companies, products and services in the field of medical devices, Seibt-Online-Database
• ECRI Institute
  Producer of Universal Medical Device Nomenclature System (UMDNS)