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 …

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 …

Is an application for determination of regulatory status, classification or categorisation of a product according to § 6 para. 1 or 2 MPDG associated with costs? Date: 04. May 2024 Topics: Medical devices Type: FAQ

Yes, fees are charged for a decision pursuant to § 6 para. 1 or 2 MPDG on the classification, determination of the regulatory status or categorisation of products in accordance with § 1 BGebG in conjunction with § 10 Table 2 No. 1 of the Annex to § 2 …

Does the BfArM maintain a list of general classifications of medical devices? Date: 04. May 2024 Topics: Medical devices Type: FAQ

The BfArM does not maintain a list of general classifications, since the examination of each individual product is conducted on a case-by-case basis, taking into account the respective intended use (e.g. instructions for use, advertising materials, …

Does the BfArM make decisions on a class of similar products? Date: 04. May 2024 Topics: Medical devices Type: FAQ

No, that is not possible. Under the conditions mentioned above, the BfArM can decide on the regulatory status, classification or categorisation of individual specific products only, not on a class of products.

Does a decision by the BfArM also constitute a statement on the marketability of the product? Date: 04. May 2024 Topics: Medical devices Type: FAQ

No, the BfArM is not authorised to do so. In Germany, monitoring the manufacture of, placing on the market and marketing of medical devices (including their operation and use) and the related implementation of the MPDG and its ordinances is the …

Who may I contact if I have further questions? Date: 04. May 2024 Topics: Medical devices Type: FAQ

Contact information on various topics can be found under FAQ and contact persons.

What are the risk classes medical devices are divided into? Date: 04. May 2024 Topics: Medical devices Type: FAQ

Medical devices are assigned to risk classes. With the exception of in vitro diagnostic medical devices, medical devices are classified according to the classification rules in Annex VIII MDR. The products are divided into four classes I, IIa, IIb …

Urgent Field Safety Notice for Kieferhöhlenstanze, Galea-Federhaken, Gaumenhaken, Biopsie- und Fasszange, optische Schere, Arbeitseinsatz mit Lenkhebel by Karl Storz S. & Co KG PDF, 266KB, File does not meet accessibility standards Date: 03. May 2024 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 35998/23

Urgent Field Safety Notice for Vercise Genus by Boston Scientific Neuromodulation Corporation PDF, 129KB, File does not meet accessibility standards Date: 02. May 2024 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 12390/24