BfArM - Federal Institute for Drugs and Medical Devices

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14,962 results

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Urgent Field Safety Notice for Elecsys CA 19-9 by Roche Diagnostics GmbH PDF, 287KB, File does not meet accessibility standards Date: 18. February 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 00936/20

Urgent Field Safety Notice for Atellica IM and ADVIA Centaur fPSA Calibrator by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 46KB, File does not meet accessibility standards Date: 18. February 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 00723/21

Urgent Field Safety Notice for Destiny Max and DT 100 by Tcoag Ireland Ltd PDF, 163KB, File does not meet accessibility standards Date: 18. February 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 00616/21

Urgent Field Safety Notice for Artis icono and Artis pheno by Siemens Healthcare GmbH Advanced Therapies PDF, 172KB, File does not meet accessibility standards Date: 17. February 2021 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 02968/21

Urgent Field Safety Notice for ophthalmological Kitpack by Lohmann & Rauscher GmbH & Co. KG PDF, 205KB, File does not meet accessibility standards Date: 17. February 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 02678/21

Urgent Field Safety Notice for Q-Flow by Merivaara Corporation PDF, 719KB, File does not meet accessibility standards Date: 17. February 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 01490/21

Urgent Field Safety Notice for ophthalmological Kitpack / Raucoset by Lohmann & Rauscher GmbH & Co. KG PDF, 99KB, File does not meet accessibility standards Date: 16. February 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 02689/21

Urgent Field Safety Notice for MAGNUS OP-Tisch by Maquet GmbH PDF, 49KB, File does not meet accessibility standards Date: 16. February 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 02701/21

Urgent Field Safety Notice for DOTCH Puru Syringe by STAXS The Netherlands BV PDF, 145KB, File does not meet accessibility standards Date: 15. February 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 02412/21

Urgent Field Safety Notice for Blasendauerkatheder by Asid Bonz GmbH PDF, 134KB, File does not meet accessibility standards Date: 15. February 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 02424/21

Urgent Field Safety Notice for Natrium Citricum 4% by Biomedica, sopl s.r.o PDF, 2MB, File does not meet accessibility standards Date: 12. February 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - therapeutic apheresis procedures
Reference 19299A/20

Urgent Field Safety Notice for FRED easy by Schiller Médical SAS PDF, 769KB, File does not meet accessibility standards Date: 11. February 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 02394/21

Urgent Field Safety Notice for Syringes with Sodium Chloride 0,9% by Steripack SA PDF, 3MB, File does not meet accessibility standards Date: 11. February 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 02219/21

Is it possible to send the clinical investigation plan to BfArM for prior inspection before submitting the application in order to shorten the approval procedure? Date: 10. February 2021 Topics: Medical devices Type: FAQ

Unfortunately, it is not possible to have application documents reviewed before the actual approval procedure. A binding statement as to whether the clinical investigation plan meets the requirements can therefore only be made after detailed …

Do clinical investigations and performance studies that started before 21 March 2010 have to be submitted or reported retroactively to the BfArM? What changes have been made since 21 March 2010? Date: 10. February 2021 Topics: Medical devices Type: FAQ

No. In accordance with Section 44 sub-section 4 of the Medical Devices Act (MPG), Sections 19 to 24 of the Medical Devices Act (MPG) as amended by the announcement of 7 August 2002 (German Federal Law Gazette I p. 3146), last amended by Article 1 of …

What changes are effective as of 21 March 2010? Date: 10. February 2021 Topics: Medical devices Type: FAQ

Since 21 March 2010, in accordance with Section 20 sub-section 1 of the Medical Devices Act (MPG), clinical investigations of medical devices may only be commenced in Germany if the responsible Ethics Committee has issued a favourable opinion on the …

How can a sponsor facilitate the processing of an application? Date: 10. February 2021 Topics: Medical devices Type: FAQ

BfArM recommends that a cover letter signed by the sponsor or a representative of the sponsor be submitted with each application, highlighting the specifics of the clinical investigation and referencing the relevant information in other documents. An …

Are clinical investigations covered by Section 23b MPG to be notified to the BfArM? Date: 10. February 2021 Topics: Medical devices Type: FAQ

No.

Which disinfectants may I use for ultrasound probes in gynaecology? Date: 10. February 2021 Topics: Medical devices Type: FAQ

The problem of the necessary (fully) virucidal disinfection of ultrasound probes in gynaecology has been discussed for many years. This can be seen in the joint statement of the Federal Institute for Drugs and Medical Devices and the Robert Koch