BfArM - Federal Institute for Drugs and Medical Devices

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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

Urgent Field Safety Notice for CGM CLINICAL Medication by CompuGroup Medical Deutschland AG PDF, 459KB, File does not meet accessibility standards Date: 02. May 2024 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - others
Reference 13704/24

Urgent Field Safety Notice for EXENT analyser by The Binding Site Group Limited PDF, 789KB, File does not meet accessibility standards Date: 02. May 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 11530/24

Urgent Field Safety Notice for OXINIUM FEMORAL HEAD by Smith & Nephew, Inc., PDF, 170KB, File does not meet accessibility standards Date: 02. May 2024 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 13366/24

Urgent Field Safety Notice for Bellavita NOVA by Drive Medical GmbH & Co. KG PDF, 549KB, File does not meet accessibility standards Date: 02. May 2024 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - ward equipment and equipment for emergency medical services
Reference 07354/24

Urgent Field Safety Notice for CGM CLINICAL Medication by CompuGroup Medical Deutschland AG PDF, 577KB, File does not meet accessibility standards Date: 02. May 2024 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - others
Reference 12879/24

Request for classification and/or qualification decision Date: 30. April 2024 Topics: Medical devices Type: Article

Request for classification and/or qualification decision

Urgent Field Safety Notice for HeartSine Samaritan PAD by Heartsine Technologies Limited PDF, 573KB, File does not meet accessibility standards Date: 30. April 2024 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 12077/24

Urgent Field Safety Notice for IMMULITE 2000 Anti-TG Ab by Siemens Healthcare Diagnostics Products Ltd. PDF, 794KB, File does not meet accessibility standards Date: 30. April 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 13164/24

Urgent Field Safety Notice for Various Mapleson F Anaesthetic Breathing Systems by Intersurgical Ltd. PDF, 384KB, File does not meet accessibility standards Date: 30. April 2024 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 13404/24

Urgent Field Safety Notice for Diverse MiniMed Insulin Pumps by Medtronic Minimed PDF, 769KB, File does not meet accessibility standards Date: 30. April 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 12658/22

Urgent Field Safety Notice for Defibrillators by Medtronic Inc PDF, 216KB, File does not meet accessibility standards Date: 29. April 2024 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - defibrillators
Reference 12866/24

Urgent Field Safety Notice for BD neXus V700 Infusion Pump by MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. PDF, 182KB, File does not meet accessibility standards Date: 29. April 2024 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 11736/24

Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc. PDF, 624KB, File does not meet accessibility standards Date: 29. April 2024 Topics: Medical devices Type: Customer information

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

Urgent Field Safety Notice for PROBP 3400, SPOT VISION SCREENER by Welch Allyn Inc PDF, 672KB, File does not meet accessibility standards Date: 29. April 2024 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electronic blood pressure monitor
Reference 13386/24

Urgent Field Safety Notice for S.A. MAX, STA-R EVOLUTION, STA COMPACT/COMPACT MAX by Diagnostica Stago PDF, 224KB, File does not meet accessibility standards Date: 26. April 2024 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 10528/24

Urgent Field Safety Notice for DIVA 24 Inc. Widescreen LCD Touch Display by Philips Medizin Systeme Böblingen GmbH PDF, 261KB, File does not meet accessibility standards Date: 26. April 2024 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 05746/24

Urgent Field Safety Notice for Esoflip dialation catheter 30mm by Covidien llc PDF, 452KB, File does not meet accessibility standards Date: 26. April 2024 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - precision instruments for gastrointestinal and urological endoscopy and hysteroscopy
Reference 13233/24