The IVDR does not define the terms. The MDR defines an invasive device as a device that enters the body, in whole or in part, through the surface of the body or through a body orifice (Article 2, 6 MDR). A surgically invasive device is an invasive …

The MPDG defines the term "residual sample" as residual material of human body substances that originates from a medically indicated collection (§ 3, MPDG).

This question cannot be answered in a blanket manner, but depends on the individual conditions in each case. Information on this can be found on the website of the working group of ethics committees that advise on this question.

In Germany, the competent higher federal authorities are responsible for notifications of or applications for approval of performance studies with companion diagnostics (CDx). This is either the Paul Ehrlich Institute (PEI) or the Federal Institute …

Information on SAE and DD reporting requirements can be found in the Applications and Reports section.

The IVDR refers to "devices manufactured and used exclusively within healthcare facilities established in the Union" (Article 5(5) IVDR). A "healthcare establishment" is defined in the IVDR as an organisation whose primary purpose is the care or …

The necessary qualifications of the investigators are checked by the ethics committee when the application is submitted. Further information can be found on the AKEK website.

As soon as a part of the performance study (such as recruitment, sample collection or application of the IVD) takes place in Germany, it must be checked whether the study is subject to a notification or authorisation requirement. The provided …

Reporting Recalls

SAE reporting for performance studies

Information on SAE and DD reporting requirements can be found in the Applications and Reports section.

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 …

Performance studies of in vitro diagnostic devices (IVDs) 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 …

Summary evaluation of serious adverse events (SAEs) and device deficiencies (DDs)
Report template version 4, 2021-06-25

Clinical investigations of medical devices that are conducted as part of the clinical evaluation for conformity assessment purposes and where the investigational device either may not yet bear a CE mark or its use in the clinical investigation is …

SAE and DD complication rates within clinical investigations or performance studies
Table version 4, 2021-06-25

Notes on completing the summary evaluation of serious adverse events (SAEs) and device deficiencies (DDs)
Version 4, 2021-06-25

In Germany, the legislation provides for a cut-off date for the transition to the new legislation for clinical investigations of medical devices. This means that all applications must be submitted and processed according to the legislation valid …

Substantial modifications to a clinical investigation must be notified to the competent ethics committee and the competent federal higher authority in accordance with Article 75 of the European Regulation 2017/745 (MDR), and Section 54 of the Medical …

Other clinical investigations "are governed by the legal basis laid down in Article 82 of Regulation (EU) 2017/745 (MDR), which is further elaborated at national level by the Medical Device Law Implementation Act …