BfArM - Federal Institute for Drugs and Medical Devices

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14,950 results

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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 …