Performance studies of in vitro diagnostic devices (IVD) that are not intended solely for research purposes and where the investigational device either may not yet bear a CE mark or its use in the performance study is outside its intended purpose and samples are taken by means of surgically invasive procedures solely for the purpose of the performance study, it is an interventional performance study according to Article 2 number 46, or the conduct of the study involves additional invasive procedures or other risks for the subjects require approval by the competent higher federal authority.

Performance studies of IVDs with CE marking, within the scope of their intended purpose and additional invasive or burdensome procedures must be notified to the competent authority.

Performance studies involving companion diagnostics using only left-over samples must be notified to the competent authority.

Substantial modifications to a performance study must be notified to the competent ethics committee and the competent federal higher authority in accordance with Article 71 of the European Regulation 2017/746 (IVDR), and Section 54 of the Medical Devices Law Implementation Act (“Medizinprodukterecht-Durchführungsgesetz”, MPDG), respectively, prior to implementation.

Since the IVDR came applicable on 26.05.2022, the reporting of serious adverse events (SAEs) and device deficiencies (DDs) must be carried out in accordance with the European Regulation 2017/746 (IVDR) in conjunction with the Medical Devices Law Implementation Act (“Medizinprodukterecht-Durchführungsgesetz”, MPDG) for all clinical investigations that must be applied for or notified to the federal higher authority.

Note: This does not apply to performance evaluation studies that were initiated under the legal framework of the MPG and are considered to have been begun at the date of application of the IVDR on 26.05.2022 within the meaning of Section 100 (3) MPDG. For these performance evaluation studies, the legal framework of the MPG and its associated ordinances, including the Medical Devices Safety Plan Ordinance (“Medizinprodukte-Sicherheitsplanverordnung”, MPSV), continues to apply.

If the sponsor has temporarily halted a performance study or has terminated a performance study early, it shall inform the Member States.