BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Search i

Search help

  • Enter one or more search terms in the search field. Upper and lower case are not relevant.
  • As soon as you have entered three letters in the search field, various search words will be suggested from which you can choose one.
  • If you are searching for a certain group of words, put these words in double quotes. The hits will then contain the words in the order you entered, e.g. "medicines for children".
  • Multiple search terms can also be combined with the Boolean operators AND and OR. When using the operator AND, the results contain the intersection of all search terms. When using the operator OR, the hits contain one of the search terms or only individual search terms. The result set is therefore significantly larger. Please note that these operators must be written in capital letters.
  • If you receive a (too) large number of hits as a result of your search, you can narrow it down by using filters. These filter options appear to the left of the search results and are subdivided into:

    • category (e.g. safety of medicinal products, medical devices, code systems)
    • format (e.g. download, risk information, DHPCs)
    • time interval (e.g. last 30 days, older than ...)
  • Selected filters can be removed individually or all at once ("Show all results").
  • By default, search results are sorted by relevance, but they can also be sorted chronologically ("Latest entries first" or "Oldest entries first").

Enter search term

14,953 results

Results per page: 10 20 30

Urgent Field Safety Notice for Procedure Trays containing Bone Wax by Mölnlycke Health Care AB PDF, 4MB, File does not meet accessibility standards Date: 28. May 2021 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - ointments and gels
Reference 09906/21

Urgent Field Safety Notice for UBC Rapid by IDL Biotech PDF, 1MB, File does not meet accessibility standards Date: 28. May 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 08116/21

Urgent Field Safety Notice for MODULA by G. Heinemann Medizintechnik GmbH PDF, 3MB, File does not meet accessibility standards Date: 28. May 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - ENT equipment
Reference 09179/21

Urgent Field Safety Notice for SoKINOX/SERViNO by Maquet Critical Care AB PDF, 336KB, File does not meet accessibility standards Date: 27. May 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 09262/21

Urgent Field Safety Notice for BVI CustomEyes Kits and Malosa Kits by Beaver Visitec International, Ltd PDF, 258KB, File does not meet accessibility standards Date: 27. May 2021 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - other medical devices for ophthalmological purposes
Reference 02413/21

Urgent Field Safety Notice for Sets und Behandlungseinheiten by Hell & Co. GmbH PDF, 410KB, File does not meet accessibility standards Date: 27. May 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 09588/21

Urgent Field Safety Notice for Venflon Pro by Becton Dickinson Infusion Therapy AB PDF, 313KB, File does not meet accessibility standards Date: 27. May 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 09719/21

Urgent Field Safety Notice for Ingenia Ambition S und Ingenia Ambition X by Philips Medical Systems Nederland B.V. PDF, 143KB, File does not meet accessibility standards Date: 27. May 2021 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for MR tomography
Reference 09806/21

Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc. PDF, 142KB, File does not meet accessibility standards Date: 27. May 2021 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - artificial hearts
Reference 21994/20

Urgent Field Safety Notice for IV Sets/ Accessories by Henry Schein Inc. PDF, 513KB, File does not meet accessibility standards Date: 27. May 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion kits
Reference 08901/21

Urgent Field Safety Notice for Bravo pH Monitoring System and Accessories by Covidien llc PDF, 337KB, File does not meet accessibility standards Date: 26. May 2021 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 04591/21

Urgent Field Safety Notice for ACUVUE Vita Brand Diagnostic Lenses by Johnson & Johnson Vision Care PDF, 172KB, File does not meet accessibility standards Date: 26. May 2021 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - contact lenses
Reference 08745/21

Urgent Field Safety Notice for ExacTrac Dynamic by Brainlab AG PDF, 355KB, File does not meet accessibility standards Date: 26. May 2021 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 15831/20

Urgent Field Safety Notice for Injizierbare Hyaluronprodukte (für Gelenke) by Anika Therapeutics S.r.l. PDF, 558KB, File does not meet accessibility standards Date: 26. May 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - materials for implants
Reference 07218/21

Urgent Field Safety Notice for Neo Delta self safe 2 17G 45mm by Delta Med spa PDF, 2MB, File does not meet accessibility standards Date: 26. May 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 09011/21

Urgent Field Safety Notice for Kangaroo Enteral Feeding No.-Sterile Pump Sets by Covidien llc PDF, 177KB, File does not meet accessibility standards Date: 26. May 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 04351/21

Urgent Field Safety Notice for HydraSense Advanced by Penta Arzneimittel GmbH PDF, 692KB, File does not meet accessibility standards Date: 21. May 2021 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - liquid media for ophthalmological purposes
Reference 09070/21

Urgent Field Safety Notice for Video Mediastinoscope by Karl Storz S. & Co KG PDF, 381KB, File does not meet accessibility standards Date: 21. May 2021 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 08998/21

Urgent Field Safety Notice for Kontaktlinsenpflegemittel by Bausch & Lomb Inc PDF, 452KB, File does not meet accessibility standards Date: 21. May 2021 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - contact lenses
Reference 08450/21

Urgent Field Safety Notice for Zimmer Natural Nail Cephalomedullary Nail by Zimmer Switzerland Manufacturing GmbH PDF, 168KB, File does not meet accessibility standards Date: 21. May 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 08799/21

Urgent Field Safety Notice for Shark CP, cervical screw by Bricon GmbH PDF, 243KB, File does not meet accessibility standards Date: 21. May 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 08859/21

Urgent Field Safety Notice for LeMaitre Aortic Occlusion Catheter by LeMaitre Vascular, Inc. PDF, 83KB, File does not meet accessibility standards Date: 21. May 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 09555/21

Urgent Field Safety Notice for MEXSOL by MEDITES PHARMA, spol. s r.o PDF, 135KB, File does not meet accessibility standards Date: 21. May 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 09488/21

Urgent Field Safety Notice for syngo.via by Siemens Healthcare GmbH, SYNGO (SY) PDF, 423KB, File does not meet accessibility standards Date: 17. May 2021 Topics: Medical devices Type: Customer information

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 09164/21

Urgent Field Safety Notice for Laryngeal Electrodes, Urethral Electrodes, Disposable needle electrodes for EEG and EMG, Disposable Stimulation Probes by SPES Medica Srl PDF, 139KB, File does not meet accessibility standards Date: 17. May 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 09046/21

How can I check and prove the validity of a certificate? Date: 14. May 2021 Topics: Medical devices Type: FAQ

Some notified bodies provide "certificate databases" on their websites for general search. Please check the certificates yourself in the public database of the notified body that issued it.

If that is not sufficient, please directly contact the …

Do importers have to notify the registration of a medical device that is already registered in a member state of the European Economic Area to the German authorities? Date: 14. May 2021 Topics: Medical devices Type: FAQ

No, it is not necessary to register products in Germany that are already registered in a member state of the European Economic Area. European importers or authorized representatives based outside of Germany do not have to notify in the German Medical …

What are the registration obligations of importers according to MDR and IVDR? Date: 14. May 2021 Topics: Medical devices Type: FAQ

Please refer to Article 13 of Regulation (EU) 2017/745 for the general obligations of importers under the MDR (effective date 5/26/2021). The effective date of the IVDR is 5/26/2022.
Under the new MDR and IVDR regulations, there is an obligation for …

What are the registration obligations of importers according to the transitional provisions of § 96 MPDG in reference to the Medical Devices Act (MPG)? Date: 14. May 2021 Topics: Medical devices Type: FAQ

There is a possibility of registering "importers" in the sense of the German Medical Devices Act (MPG), however, we want to point out the definition in § 5 MPG. It is stated there that the importer is the responsible person if medical devices are not …

Can BfArM validate the authenticity of certificates for medical devices? Date: 14. May 2021 Topics: Medical devices Type: FAQ

No, BfArM cannot provide any information on the authenticity or validity of certificates.