Clinical trials of medical devices; application for approval to perform

If, as a manufacturer of medical devices, you wish to conduct clinical trials, you may need to apply for approval from the Federal Institute for Drugs and Medical Devices (BfArM).

Description

Prerequisites

To obtain authorization to conduct clinical trials for medical devices, the following requirements must be met:

  • you or your legal representative must be established in the European Union
  • the application documents must be complete
  • the product or the submitted documents, especially the protocol and the investigator's manual, must be in accordance with the state of scientific knowledge
  • the clinical trial must be suitable to provide evidence for the safety, performance characteristics or benefit of the product for the trial subjects or patients
  • clinical trials must be designed and conducted in such a way that
    • the protection of the rights, safety, dignity and well-being of the trial subjects is ensured and takes precedence over all other interests; and
    • the clinical data generated are scientifically sound, reliable and robust
  • an independent ethics committee must have reviewed the clinical trial ethically in advance and approved the trial
  • The following vulnerable groups of persons are given special protection:
    • persons who are not capable of giving their own consent
    • Minors
    • pregnant or breastfeeding women
    • Persons doing compulsory military service
    • Persons in the penal system
    • Persons who are not allowed to participate in a clinical trial due to a court decision
    • Persons who are accommodated in a nursing home
    • persons in medical emergencies
  • the expected benefits justify the foreseeable risks and disadvantages and compliance with this condition is constantly monitored
  • the subjects' right to physical and mental integrity, privacy and protection of their personal data is respected
  • The trial is planned to minimize pain, discomfort, anxiety, and all other foreseeable risks to subjects, and both the risk threshold and the level of distress are specifically defined in the protocol and are kept under review
  • a suitably qualified physician or any other person authorized to provide appropriate care for patients in a clinical trial is responsible for the medical care of the trial subjects
  • subjects or their legal representatives, if any, are not subjected to undue influence, such as financial, to induce them to participate in the trial
  • the trial must be conducted only by qualified personnel
  • the premises in which the clinical trial is to be conducted must be suitable for the clinical trial and similar to the premises in which the product is to be used
  • the investigational devices must be shown to comply with the essential European-wide safety and performance requirements
  • all precautions must have been taken to protect the health and safety of the trial subjects
  • the risk mitigation solutions you use must comply with EU legislation and, if not, the risk mitigation solutions must provide an equivalent level of protection
  • the planned measures for safe installation, commissioning and maintenance of the investigational device must be adequate
  • the data generated in the clinical trial must be reliable and robust
  • for devices intended for sterile applications, the manufacturer's sterilization procedures must be validated
  • components that are of human or animal origin, as well as substances that may be considered medicinal products under EU law, must be demonstrated to be safe, of high quality, and of reasonable use
  • Medical devices intended for clinical trials must bear the statement "for clinical trials only"
    • The labeling must
      • ensure the protection of subjects, users or third parties and traceability
      • allow identification of the individual medical device, and
      • ensure proper use of the medical device.

Procedure

You can apply for approval for clinical trials of medical devices electronically. Before you submit your application, you can contact the BfArM for advice.

  • Call up the online portal of the German Medical Devices Information and Database System (DMIDS) of the BfArM and log in with your user data.
    • If you do not yet have access authorization (user code), you must apply for it once.
  • Navigate to the "Clinical Trials" section and fill out the application there using the "Capture" option.
  • Submit your application through the DMIDS.
  • As part of the sequential application procedure, the application will first be forwarded to the responsible ethics committee and can only be sent to the responsible higher federal authority after the evaluation there has been completed.
  • In case of formal deficiencies, you will receive a deficiency letter with the request to submit the missing documents.
  • As soon as the application documents have been received in full by the BfArM, you will receive a confirmation of receipt of the correct application.
  • For clinical trial applications, the BfArM usually applies for the Eudamed identification number for the European database Eudamed on your behalf and enters it in your application.
  • The BfArM and the responsible ethics committee review your application and the submitted documents.
  • The responsible ethics committee will notify the BfArM of its decision. Regardless of this, you must subsequently submit the opinion of the Ethics Committee to the BfArM.

Special notes

According to Article 70(1) of Regulation (EU) 2017/745 (MDR), the application has to be submitted via the electronic system according to Article 73 MDR. This system is EUDAMED (European Database on Medical Devices), which is currently still being created. Until the corresponding functionalities for application submission in EUDAMED are available, the application for approval of a clinical trial of a medical device must be submitted via the German Medical Devices Information and Database System (DMIDS) of the Federal Institute for Drugs and Medical Devices.

Deadlines

If the BfArM raises justified objections to your application, you must submit a statement or complete your application documents within 10 days. Otherwise, your application will be deemed to have lapsed. This deadline may be extended to a maximum of 20 days.

If additional information is requested from you by the BfArM during the substantive review phase, it must be submitted within 90 days. The expiry of the authority's deadline (45 days) is suspended until the additional information is received (clock stop).

Processing time

Processing time (normally) for checking whether the application and documentation are complete and fall within the scope of the relevant EU regulation (10 days).

Required documents

  • Required document/s

    • Manual of the investigator
    • Signed clinical trial protocol
    • If the protocol is available in English: additional summary of the main contents of the protocol in German (synopsis)
    • signed declaration of the manufacturer,
      • that the device in question complies with the essential safety and performance requirements with the exception of the points covered by the clinical investigation, and
      • that all precautionary measures have been taken to protect the health and safety of the trial subjects with regard to these points
    • A copy of the vote of the ethics committee
    • Proof of insurance of the trial subjects or patients
    • Documents for obtaining informed consent
    • Information on the protection and confidentiality of personal data
    • at the request of the competent authority, full details of the documentation, for example risk analysis or management or specific test reports
    • if you have appointed a representative: Power of attorney for the representative you have appointed

    additional documents recommended by the BfArM:

    • if you or your representative have commissioned third parties: Power of attorney for third parties appointed by you
    • for each application submitted, a cover letter signed by you or your representative, highlighting the special features of the clinical trial and referring to the references of the relevant information in the additional documents
    • a corresponding cover letter for each subsequent submission

Online procedures

  • Deutsches Medizinprodukte-Informations- und Datenbanksystem (DMIDS)

    The information system on medical devices enables the recording, processing and online transmission of notifications and applications by notifying parties/applicants, sponsors, ethics committees, notified bodies and competent authorities.
    An individual access authorization is required to access the information system. This must be applied for.

Fees

  • Fee: 3000 EUR - 9900 EUR

Remedy

  • Appeal. Explanations on how to lodge an appeal can be found in the notice accompanying your application.

Status:10.06.2022

Responsible for editing:Bundesministerium für Gesundheit

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