Performance studies involving companion diagnostics (CDx) in which only left-over samples are used must be notified to the competent authority in accordance with Article 58(2), sentences 2 and 3 IVDR, and Section 31b MPDG.

The notification is made via the electronic system according to Article 69 IVDR.

As long as the central European database EUDAMED does not provide the corresponding functionality, the application is submitted via the German Medical Devices Information and Database System (“Deutsche Medizinprodukte-Informations- und Datenbanksystem”, DMIDS) of the Federal Institute for Drugs and Medical Devices (BfArM).

Pursuant to Section 31b (2) MPDG, the notification shall contain the following information and documents, which are transmitted via the electronic system:

1. the name, address and contact details of the sponsor and, where applicable, of its legal representative established in the European Union in accordance with Article 58(4) of Regulation (EU) 2017/746,
2. the name, address and contact details of the manufacturer of the companion diagnostic to be subjected to a performance evaluation and, if different from point 1, of its authorised representative, if applicable,
3. the name of the performance study
4. a brief description of the companion diagnostic that is the subject of the performance study,
5. the International Nonproprietary Name (INN) of the associated medicinal product,
6. the performance study plan according to Section 2.3.2. of Part A of Annex XIII to Regulation (EU) 2017/746; and
7. the origin of the samples to be tested.

Competent higher federal authority

A performance study of a companion diagnostic in which only leftover samples are used must be notified to the competent authority. In Germany, these are the higher federal competent authorities, either the Paul Ehrlich Institute (PEI) or the Federal Institute for Drugs and Medical Devices (BfArM). Which of the two higher federal competent authorities is to be notified of the performance study depends on the regulatory responsibility for the associated medicinal product:

According to Section 85 Paragraph 3 No. 2 MPDG, the higher federal competent authority (PEI or BfArM) is responsible for approving a performance study with a companion diagnostic intended for the safe and effective use of an associated medicinal product, which is also responsible for the associated medicinal product according to the Medicinal Products Act.