BfArM - Federal Institute for Drugs and Medical Devices

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ORPHANET - 25 Years and Counting PDF, 6MB, File does not meet accessibility standards Date: 13. December 2022 Topics: Kodiersysteme Type: Download

ORPHANET - 25 Years and Counting

Which powers of attorney should be included with the application? Date: 22. November 2022 Topics: Medical devices Type: FAQ

In the case of an application for authorisation of a clinical investigation under the MDR or a performance study under the IVDR, a power of attorney for the legal representative of the sponsor in the Union (cf. Article 62 (2) and (4) (c) MDR or …

Agenda Iris User Group Meeting 2022 PDF, 140KB, File is accessible Date: 08. November 2022 Topics: Kodiersysteme Type: Download

Agenda Iris User Group Meeting 2022

Presentation Iris-11 Webinar - September 2023 zip, 5MB, File does not meet accessibility standards Date: 11. October 2022 Topics: Kodiersysteme Type: Download

Presentation Iris-11 Webinar - September 2023

Which SAE and DD reporting obligations apply from the date of application of the MDR 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 clinical investigations

Is there a transition period for applications for authorisation of a clinical investigation of medical devices? Date: 17. August 2022 Topics: Medical devices Type: FAQ

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 …

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 (“ …

When is it an additional invasive procedure or other risks to subjects? Date: 17. August 2022 Topics: Medical devices Type: FAQ

If there is uncertainty as to whether the procedure is an additional invasive procedure or whether there are other risks to the trial subjects, the ethics committee can provide advice.
Further information from AKEK

Alternatively, a decision can be …

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 …