To request a decision on classification and/or differentiation by the BfArM, an informal application for classification and/or differentiation must be submitted to the BfArM in accordance with Section 6 (2) of the Medical Device Law Implementation Act (MPDG). In principle, a Notified Body, the manufacturer, his authorized representative or the state Competent Authority are entitled to file an application.
We would like to point out, that individually attributable public services are generally subject to fees according to § 87 MPDG in conjunction with § 2 “Medizinprodukterecht-Durchführungsgesetz-Gebührenverordnung” (MPDGGebV).

Decisions can only be made for individual, defined products on the basis of the individual intended use as well as the information for use and, if applicable, advertising documents, etc., not for entire product groups.

The following documents on the specific product must at least be attached to the informal, signed application in order to enable a proper decision:

• Trade name of the product including the version number of the software used, precise details of the manufacturer.

• Excerpts from the technical documentation of the product with information on:

  • Intended use,
  • classification,
  • instructions for use,
  • labeling and packaging,
  • product description,
• if applicable, mechanism of action with appropriate supporting documents,
• advertising material incl. internet advertising,
• if applicable, sample or sample copy,
• signature of the applicant,
• a written power of attorney if the application is made by a third party on behalf of the manufacturer.

It is required, that the applicant makes an assessment with justification on the issue of classification of the product, and attaches it to the application.

Please send your application by e-mail to: mp-klar@bfarm.de . For general enquiries about classification and/or differentiation before submitting an application, please use our contact form.

The differentiation of a device is based on the definition of medical devices in article 2 No. 1 of Regulation (EU) 2017/745 (Medical Device Regulation, MDR). The classification is based on the classification rules of Annex VIII of the MDR. For decision-making purposes, other sources may be consulted, such as the MEDDEV documents of the European Commission, which can be found at:

http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm
(Area 2.1 "Scope, field of application, definition" and Area 2.4 "Classification of MD-medical devices")

In the case of applications by state Competent Authorities and Notified Bodies, the manufacturer is always given the opportunity to comment. Lists of state Competent Authorities in Germany, Notified Bodies and the Competent Authorities of the other EEA member states can be found on the Competent Institutions website (in German).