BfArM - Federal Institute for Drugs and Medical Devices

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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