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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