Advertisement of the commercial handling of medical devices Transmission Unfortunately this specification of service has not yet been completely translated.

Medical devices are instruments, apparatus, apparatus, software and substances (or preparations of substances) used for human use for the following purposes: detection, prevention, monitoring, treatment or alleviation of diseases, detection, monitoring, treatment, alleviation or compensation of injuries or disabilities; examination, replacement or modification of the anatomical structure or physiological process, or the contraceptive regime. If you are based in Germany and put medical devices on the market for the first time, Prepare medical devices exclusively for others that are intended to be used in a germ-poor or sterile way, place on the market systems or treatment units composed using medical devices, or sterilize these or other medical devices for the first time on the market, you have to notify the LAVG with your address before starting your activity. Before starting your activity, you, as a manufacturer, must indicate the name and description of the medical devices concerned when displaying composite systems and treatment units. If you, as a manufacturer, wish to sterilize these or other medical devices before using them, you must also indicate the designation before starting the activity. If you, as a manufacturer or his authorised person, have your registered office in Germany and place in vitro diagnostics on the market for the first time, please indicate to the LAVG, indicating your address before starting your activity: - the information relating to common technological characteristics and analytes on reagents, medical devices containing reagents and calibration and control materials, and other in vitro diagnostics, the appropriate information, - in the case of in vitro diagnostics referred to in Annex II to Directive 98/79/EC and in vitro self-use diagnostics, all the information enabling the identification of these in vitro diagnostics, the analytical and, where appropriate, diagnostic performance data referred to in Section 3 of Annex I A, Point 3 of Directive 98/79/EC, the results of the performance assessment and information on certificates, - in the case of a "new in vitro diagnostic" additionally the indication that it is a "new in vitro diagnostic". Subsequent changes to the information and a cessation of the placing on the market must be reported immediately. The competent authority is the LAVG. According to the DIMDI Regulation, the advertisement must be made via the Internet portal of the German Institute for Medical Documentation and Information ( www.dimdi.de ).

For information on possible required data, refer to the instructions on the DIMDI website .


Written form required: no Personal appearance necessary: no

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Preconditions
For medical devices placed on the market in Germany, the wearing of a CE marking is mandatory. CE certification requires the successful passage of a process to confirm the essential requirements in accordance with EU legal requirements for medical devices (conformity assessment procedures). Depending on the risk class of the medical device, the involvement of a notified body may be necessary.
- on the internal side of the DIMDI information on: legal framework Notification and reporting channels for manufacturers, clinical trials and incidents competent authorities in Germany and in the European Union.

Related Links

Before you place medical devices on the market for the first time, view them online: Complete your online application at www.dimdi.de. Share your data and send it online. The LAVG will be automatically informed of your display. The LAVG finally edits your ad and releases it in the DIMDI database. You will automatically receive feedback from the LAVG about the release of the data.

Responsible for the content
Ministry of Social Affairs, Health, Integration and Consumer Protection of the State of Brandenburg

Last update or date of publication
27.11.2019