BfArM - Federal Institute for Drugs and Medical Devices

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14,953 results

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Urgent Field Safety Notice for DOTCH Puru Syringe by STAXS The Netherlands BV PDF, 145KB, File does not meet accessibility standards Date: 15. February 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 02412/21

Urgent Field Safety Notice for Blasendauerkatheder by Asid Bonz GmbH PDF, 134KB, File does not meet accessibility standards Date: 15. February 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 02424/21

Urgent Field Safety Notice for Natrium Citricum 4% by Biomedica, sopl s.r.o PDF, 2MB, File does not meet accessibility standards Date: 12. February 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - therapeutic apheresis procedures
Reference 19299A/20

Urgent Field Safety Notice for FRED easy by Schiller Médical SAS PDF, 769KB, File does not meet accessibility standards Date: 11. February 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 02394/21

Urgent Field Safety Notice for Syringes with Sodium Chloride 0,9% by Steripack SA PDF, 3MB, File does not meet accessibility standards Date: 11. February 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 02219/21

Is it possible to send the clinical investigation plan to BfArM for prior inspection before submitting the application in order to shorten the approval procedure? Date: 10. February 2021 Topics: Medical devices Type: FAQ

Unfortunately, it is not possible to have application documents reviewed before the actual approval procedure. A binding statement as to whether the clinical investigation plan meets the requirements can therefore only be made after detailed …

Do clinical investigations and performance studies that started before 21 March 2010 have to be submitted or reported retroactively to the BfArM? What changes have been made since 21 March 2010? Date: 10. February 2021 Topics: Medical devices Type: FAQ

No. In accordance with Section 44 sub-section 4 of the Medical Devices Act (MPG), Sections 19 to 24 of the Medical Devices Act (MPG) as amended by the announcement of 7 August 2002 (German Federal Law Gazette I p. 3146), last amended by Article 1 of …

What changes are effective as of 21 March 2010? Date: 10. February 2021 Topics: Medical devices Type: FAQ

Since 21 March 2010, in accordance with Section 20 sub-section 1 of the Medical Devices Act (MPG), clinical investigations of medical devices may only be commenced in Germany if the responsible Ethics Committee has issued a favourable opinion on the …

How can a sponsor facilitate the processing of an application? Date: 10. February 2021 Topics: Medical devices Type: FAQ

BfArM recommends that a cover letter signed by the sponsor or a representative of the sponsor be submitted with each application, highlighting the specifics of the clinical investigation and referencing the relevant information in other documents. An …

Are clinical investigations covered by Section 23b MPG to be notified to the BfArM? Date: 10. February 2021 Topics: Medical devices Type: FAQ

No.

Which disinfectants may I use for ultrasound probes in gynaecology? Date: 10. February 2021 Topics: Medical devices Type: FAQ

The problem of the necessary (fully) virucidal disinfection of ultrasound probes in gynaecology has been discussed for many years. This can be seen in the joint statement of the Federal Institute for Drugs and Medical Devices and the Robert Koch

As a manufacturer of medical devices, what do I have to bear in mind when I want to launch a new medical device on the German market? Date: 10. February 2021 Topics: Medical devices Type: FAQ

The monitoring of the manufacture, placing on the market and circulation of medical devices (including their operation and use) and the related implementation of the Medical Devices Act and its ordinances is the exclusive responsibility of the state …

We are a foreign manufacturer of medical products and would like to market our medical products in Germany as well. Is our CE mark also valid in Germany? Date: 10. February 2021 Topics: Medical devices Type: FAQ

If you have a CE mark for your medical product that is valid for the European market, you can also market the product in Germany. You can find an overview of the relevant EU directives for CE marking under the following link:

Is it true that the RKI-BfArM recommendation was revised in 2012? Date: 10. February 2021 Topics: Medical devices Type: FAQ

Who is responsible for ensuring that the processing is carried out properly? Date: 10. February 2021 Topics: Medical devices Type: FAQ

The user/operator is responsible for a proper execution of the entire reprocessing procedure, taking into account the manufacturer's specifications.

Where can I find information on endoscope reprocessing? Date: 10. February 2021 Topics: Medical devices Type: FAQ

In Annex 8 of the joint recommendation of the Robert Koch Institute and the BfArM on hygiene requirements for the reprocessing of medical devices (so-called RKI-BfArM recommendation) under the following link:

We are manufacturers of medical products and require export certificates. Can you provide us with these? Date: 10. February 2021 Topics: Medical devices Type: FAQ

The BfArM does not issue export certificates. According to § 34 (1) MPG the competent authority issues a certificate of marketability of the medical device in Germany upon application of a manufacturer or authorised representative for export. We …

I am addressing you as a citizen and I need a certain medical aid. Can you tell me whether the statutory health insurance pays for this medical device? Date: 10. February 2021 Topics: Medical devices Type: FAQ

Questions on the eligibility for reimbursement of medical devices are not within the scope of responsibility of the BfArM. We therefore ask you to contact the Kassenärztliche Vereinigung in your federal state.

Can you please send us standards on a specific topic? Date: 10. February 2021 Topics: Medical devices Type: FAQ

Unfortunately, this is not possible for us, as standards are subject to copyright protection and may not be reproduced. An overview of standards and procurement options can be found at Beuth-Verlag (www.beuth.de).

Where can I order the RKI-BfArM recommendation for the reprocessing of medical devices? Date: 10. February 2021 Topics: Medical devices Type: FAQ

The joint recommendation of the Robert Koch Institute and the BfArM on hygiene requirements for the reprocessing of medical devices (so-called RKI-BfArM recommendation) is available free of charge.
You can find it under the following link:

What is meant by an evaluation and assessment of risks and benefits according to Section 3 sub-section 2 number 5 of the Ordinance on Clinical Investigations of Medical Devices (MPKPV)? Date: 10. February 2021 Topics: Medical devices Type: FAQ

The sponsor must submit an evaluation and assessment of the foreseeable risks, disadvantages and distress for the trial subject weighed against the prospective significance of the medical device for medical science and the anticipated benefit for the …

A clinical investigation for a medical device has already been approved by the BfArM. Is it possible to refer to the previous approval in another clinical investigation with exactly the same medical device? Date: 10. February 2021 Topics: Medical devices Type: FAQ

In accordance with Section 3 sub-sections 2 and 4 as well as with Section 7 sub-section 2 of the Ordinance on Clinical Investigations of Medical Devices (MPKPV), the requirements for the documents to be submitted remain the same even if a new …

Urgent Field Safety Notice for PL Elastics by FlexMedics PDF, 77KB, File does not meet accessibility standards Date: 10. February 2021 Topics: Medical devices Type: Customer information

Product group Dental products - others
Reference 02018/21

Urgent Field Safety Notice for Mediplus by Mediplus Ltd. PDF, 126KB, File does not meet accessibility standards Date: 10. February 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - injection kits
Reference 02409/21

Urgent Field Safety Notice for Acuson Sequoia by Siemens Medical Solutions USA, Inc., Ultrasound Division PDF, 84KB, File does not meet accessibility standards Date: 10. February 2021 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 02095/21

Urgent Field Safety Notice for Anchor Bolt by AD-TECH MEDICAL INSTRUMENT CORPORATION PDF, 829KB, File does not meet accessibility standards Date: 09. February 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 18117/20

Urgent Field Safety Notice for BD Syringes and Needles by Becton Dickinson France S.A.S. PDF, 933KB, File does not meet accessibility standards Date: 09. February 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 01964/21

Urgent Field Safety Notice for Custom Tubing set by Maquet Cardiopulmonary GmbH PDF, 82KB, File does not meet accessibility standards Date: 09. February 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 01155/21

Urgent Field Safety Notice for Bodyguard 121 Twins by Caesarea Medical Electronics Ltd. PDF, 227KB, File does not meet accessibility standards Date: 08. February 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 01707/21