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Classification and Demarcation of Medical Devices

Medical devices other than active implantable medical devices are classified. The classification is based on the classification rules in Appendix IX of Directive 93/42/EEC. In vitro diagnostics are assigned according to a list from Appendix II of Directive 98/79/EC, or are devices for self-testing or other devices.

When there are differences of opinion between the manufacturer and the notified body, the competent authority (BfArM or PEI) decides on the classification of medical devices or the assignment of an IVD (according to § 13 Medical Devices Act, MPG).

The competent authorities enter the notifications in the Medical Devices Information System for the classification of medical devices or demarcation as non-medical devices. The contents of the MD classification/demarcation database are based on Annex 5 of the DIMDI-Verordnung. Only the competent authorities currently have access to this database.