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When are performance studies subject to approval or notification? Date: 17. August 2022 Topics: Medical devices Type: FAQ

The provided decision tree serves as a guide as to which performance studies are subject to approval or notification. The information from Chapter VI of the IVDR and Chapter 4 of the MPDG is decisive.

If there is a need for clarification, the BfArM …

Which performance studies (previously performance evaluation studies) may be continued under the MPG? Date: 17. August 2022 Topics: Medical devices Type: FAQ

In the European Regulation 2017/746 (IVDR), there is no guidance on performance studies for the transition from the In Vitro Diagnostics Directive (IVDD, 98/79/EC) to the IVDR. However, the German Medical Devices Implementation Act (“ …

How is a (surgically) invasive procedure defined? Date: 17. August 2022 Topics: Medical devices Type: FAQ

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 …

How are residual samples defined? Date: 17. August 2022 Topics: Medical devices Type: FAQ

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

Which procedures are to be considered additionally burdensome (in the context of PMPF studies)? Date: 17. August 2022 Topics: Medical devices Type: FAQ

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.

Which competent higher federal authority is responsible for the performance study of a companion diagnostic (CDx)? Date: 17. August 2022 Topics: Medical devices Type: FAQ

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 …

Which SAE and DD reporting obligations apply from the date of application of the IVDR in Germany? Date: 17. August 2022 Topics: Medical devices Type: FAQ

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

SAE and DD reporting for performance studies

What is meant by "in-house developed tests" (sometimes also lab-developed tests or in-house tests) and what are the requirements for them? Date: 17. August 2022 Topics: Medical devices Type: FAQ

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 …

What are the requirements for testing bodies and investigators? Date: 17. August 2022 Topics: Medical devices Type: FAQ

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.

In which member state must a performance study be approved or notified? Date: 17. August 2022 Topics: Medical devices Type: FAQ

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 …