BfArM - Federal Institute for Drugs and Medical Devices

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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

Urgent Field Safety Notice for CAT Combat Application Tourniquet, schwarzGeneration 7C-A-TQT BLK BASE/GS ASSYENHANCD DESIGN TACTICAL BLACK C-A-TOURINIQUET WITH ELLIPTICAL END PROFILE by C.A.T Resources, LLC PDF, 98KB, File does not meet accessibility standards Date: 08. February 2021 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - medico-mechanical devices
Reference 01017/21