BfArM - Federal Institute for Drugs and Medical Devices

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Terlipressin-containing medicinal products: Safety review Date: 30. December 2022 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: terlipressin

The BfArM has implemented the decision of the CMDh dated 10 November 2022 regarding terlipressin-containing drugs at national level by official notice, dated 19 December 2022.

Studies at Synchron Research Services, India: review with regard to the conduct of studies Date: 19. December 2022 Type: Risk Assessment Procedures

Active substance: various

The Federal Institute for Drugs and Medical Devices (BfArM) implements the EU Commission's implementing decision of 28.11.2022 nationally by notice of 13 December 2022.

Medicines containing nomegestrol or chlormadinone: Risk of meningioma Date: 24. November 2022 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: nomegestrol, chlormadinone

The Federal Institute for Drugs and Medical Devices (BfArM) implements the decision of the European Commission C(2022) 7954 (final) of 28.10.2022 with a notice in the national graduated plan procedure, dated 22 November 2022.

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 …

Rubraca® (rucaparib camsylate): Cancer drug review based on preliminary study results Date: 30. September 2022 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: rucaparib camsylate

With the publication of the European Commission Decision on 21 September 2022, the Risk Assessment Procedure under Article 20 of Regulation (EC) No 726/2004 concerning "Rubraca - Rucaparib" was finalised.

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 …