BfArM - Federal Institute for Drugs and Medical Devices

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14,909 results

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Urgent Field Safety Notice for Optima Coil System, Prestige Coil System by BALT USA LLC PDF, 481KB, File does not meet accessibility standards Date: 16. May 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 15480/24

Urgent Field Safety Notice for REAL INTELLIGENCE CORI by Blue Belt Technologies, Inc. PDF, 308KB, File does not meet accessibility standards Date: 15. May 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 14732/24

Urgent Field Safety Notice for Exactech Optetrak Patella UHMWPE by EXACTECH, Inc. PDF, 392KB, File does not meet accessibility standards Date: 15. May 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 12565/24

Urgent Field Safety Notice for Molex SFP+-Modul by Barco PDF, 2MB, File does not meet accessibility standards Date: 14. May 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 13425/24

Urgent Field Safety Notice for Katheterset Arteriofix 20 G / 80 mm by B. Braun Melsungen AG PDF, 486KB, File does not meet accessibility standards Date: 14. May 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 13106/24

Urgent Field Safety Notice for Fabian HFO / HFOi by Acutronic Medical Systems AG PDF, 1MB, File does not meet accessibility standards Date: 14. May 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 12264/24

Urgent Field Safety Notice for LINK Endo-Model EVO -W, Femoral Component by Waldemar Link GmbH & Co. KG PDF, 3MB, File does not meet accessibility standards Date: 14. May 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 13821/24

Urgent Field Safety Notice for Endoscope lens cleaner, gas/fluid, single-use by Gyrus ACMI - Olympus - OSTA PDF, 257KB, File does not meet accessibility standards Date: 14. May 2024 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 13632/24

Urgent Field Safety Notice for Overtube in Suprasorb CNP endo Kit Oral by Lohmann und Rauscher GmbH & Co. KG PDF, 175KB, File does not meet accessibility standards Date: 13. May 2024 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 14608/24

Urgent Field Safety Notice for HeartMate System Monitor by Thoratec Corporation PDF, 576KB, File does not meet accessibility standards Date: 13. May 2024 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - artificial hearts
Reference 14840/24

Urgent Field Safety Notice for Rad-G Pulse Oximeter by Masimo Corporation PDF, 222KB, File does not meet accessibility standards Date: 13. May 2024 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 09986/24

Urgent Field Safety Notice for MultiPulse HoPLUS by Asclepion Laser Technologies GmbH PDF, 1MB, File does not meet accessibility standards Date: 10. May 2024 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - laser technology
Reference 14228/24

Urgent Field Safety Notice for ClearCut & A-OK V-Lance ophthalmic knives by Alcon Laboratories, Inc. PDF, 122KB, File does not meet accessibility standards Date: 10. May 2024 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - eye surgery
Reference 13610/24

Urgent Field Safety Notice for Hoffmann LRF Wire Tensioner by Stryker Trauma AG PDF, 650KB, File does not meet accessibility standards Date: 08. May 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 14246/24

Urgent Field Safety Notice for EXETER 2.5 I M PLUG by Stryker Joint Replacement PDF, 1,011KB, File does not meet accessibility standards Date: 08. May 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 13427/24

Urgent Field Safety Notice for Aeson Total Artificial Heart by CARMAT SA PDF, 131KB, File does not meet accessibility standards Date: 08. May 2024 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - artificial hearts
Reference 39484/23

Urgent Field Safety Notice for CORTSCR ø3.5 SELF-TAP L18 TAN by Oberdorf Synthes Produktions GmbH PDF, 1MB, File does not meet accessibility standards Date: 08. May 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 38850/23

Urgent Field Safety Notice for Aeson Total Artificial Heart by CARMAT SA PDF, 375KB, File does not meet accessibility standards Date: 08. May 2024 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - artificial hearts
Reference 29708/23

Urgent Field Safety Notice for FiberOptix Ultra 8 IAB Ultra 8 IAB UltraFlex IAB by Arrow International Inc. US PDF, 3MB, File does not meet accessibility standards Date: 07. May 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 13696/24

Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 1MB, File does not meet accessibility standards Date: 07. May 2024 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - others
Reference 13256/24

Urgent Field Safety Notice for LARAH Hookup by Cantel Medical (Italy) S.r.l. PDF, 338KB, File does not meet accessibility standards Date: 07. May 2024 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 13044/24

Urgent Field Safety Notice for EMPOWR 3D Knee System & EMPOWR P.S. Knee System by Encore Medical, LP (dba DJO Surgical) PDF, 2MB, File does not meet accessibility standards Date: 07. May 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 03340/24

I am a manufacturer and do not know whether my product is a medical device. How do I proceed? Date: 04. May 2024 Topics: Medical devices Type: FAQ

The classification of a device as a medical device is determined by the manufacturer with the intended purpose for which the device is intended according to the information on the label, in the instructions for use or in the promotional or sales …

I am a manufacturer of a medical device and do not know in which risk class I should classify my medical device. How do I proceed? Date: 04. May 2024 Topics: Medical devices Type: FAQ

Classification is carried out according to the classification rules of Annex VIII MDR and for in vitro diagnostic medical devices according to the classification rules of Annex VIII IVDR. The intended purpose of the product, which is determined by …

Where can I find information on the regulatory status, classification or categorisation of medical devices? Date: 04. May 2024 Topics: Medical devices Type: FAQ

Other sources can be used for decision-making such as the documents of the European Commission, which you can access at

https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

The …

In which case can an application for determination of the regulatory status, classification or categorisation of a product be submitted in accordance with § 6 para. 1 or 2 MPDG? Date: 04. May 2024 Topics: Medical devices Type: FAQ

In the event of dispute between the manufacturer and its notified body, the manufacturer with a registered place of business in Germany or its notified body are entitled to submit an application in accordance with § 6 para. 1 MPDG.

The authority of …

What is meant by "determination of regulatory status"? Date: 04. May 2024 Topics: Medical devices Type: FAQ

The BfArM decides on the regulatory status (formerly "demarcation") of a device as a medical device or accessory to a medical device, or the regularory status of a device as a product listed in Annex XVI of Regulation (EU) 2017/745 upon application …

What is meant by a decision on the "categorisation of a product" in class I? Date: 04. May 2024 Topics: Medical devices Type: FAQ

The BfArM decides on the categorisation of a class I device as follows upon application in accordance with § 6 para. 2 MPDG
a) reusable surgical instrument,
b) device that is placed on the market in a sterile condition or
c) device with measuring …

In what form can applications for determination of the regulatory status, classification or categorisation of a product be submitted in accordance with § 6 para. 1 or 2 MPDG? Date: 04. May 2024 Topics: Medical devices Type: FAQ

Applications in accordance with § 6 para. 1 and 2 can be submitted informally. This should be done electronically as PDF file(s) by e-mail to mp-klar@bfarm.de . Please …

What documents must be submitted to the BfArM for applications to determine the regulatory status, classification or categorisation of the product in accordance with § 6 para.1 or 2 MPDG? Date: 04. May 2024 Topics: Medical devices Type: FAQ

Formulate your application as an informal, signed application in accordance with § 6 para. 1 or § 6 para. 2 no. 1-3 MPDG and please specify which decision is to be made regarding your product.

To enable a proper decision to be made, please enclose …