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

Before a new medical device is placed on the market, clinical trials may need to be conducted to collect data on aspects of the safety and performance of the medical device that can only be verified in clinical practice. A clinical trial is conducted on volunteers or patients. Such a trial is required if clinical data from the literature, from clinical experience, or from clinical trials previously conducted are insufficient to support the conformity assessment procedure.

Certain clinical trials may only be started after the responsible ethics committee has approved the trial and the Federal Institute for Drugs and Medical Devices (BfArM) has authorized the trial. This applies to clinical trials

  • which serve or are intended to serve in the future to support a conformity assessment procedure
  • are to be used in the future

and

  • which are carried out with test products that are not yet allowed to bear a CE marking, or
  • are used outside the intended purpose defined by the manufacturer.


You can find out which ethics committee is responsible in your case from the German Medical Devices Information and Database System (DMIDS) of the BfArM. The necessary applications to the ethics committees are also available in the DMIDS online portal. Other, so-called other clinical trials are subject to a notification requirement, which is handled via the DMIDS; these other clinical trials also require an evaluation by an ethics committee before they can be conducted.

The decisive point for the start of the clinical trial is the time at which the first trial subject has legally consented to the trial after all requirements for the start of the clinical trial have been met.

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

  • Erforderliche Unterlage/n

    • Handbuch der Prüferin oder des Prüfers
    • unterzeichneter klinischer Prüfplan
    • Sollte der Prüfplan in englischer Sprache vorliegen: zusätzliche Zusammenfassung der wesentlichen Inhalte des Prüfplans in deutscher Sprache (Synopse)
    • unterzeichnete Erklärung des Herstellers,
      • dass das betreffende Produkt mit Ausnahme der Punkte, die Gegenstand der klinischen Prüfung sind, den grundlegenden Sicherheits- und Leistungsanforderungen entspricht und
      • dass hinsichtlich dieser Punkte alle Vorsichtsmaßnahmen zum Schutz der Gesundheit und der Sicherheit der Prüfungsteilnehmenden getroffen wurden
    • Votum der Ethik-Kommission in Kopie
    • Nachweis über die Versicherung der Probandinnen und Probanden beziehungsweise der Patientinnen und Patienten
    • Dokumente zur Einholung der Einwilligung nach Aufklärung
    • Angaben zum Schutz und zur Vertraulichkeit personenbezogener Daten
    • auf Anfrage der zuständigen Behörde vollständige Angaben zur Dokumentation, zum Beispiel Risikoanalyse oder -management oder spezifische Testberichte
    • wenn Sie eine Vertretung bestimmt haben: Vollmacht für die von Ihnen bestellte Vertretungsperson

    vom BfArM empfohlene zusätzliche Unterlagen:

    • wenn Sie oder Ihre Vertretungsperson Dritte beauftragt haben: Vollmacht für von Ihnen beauftragte Dritte
    • zu jedem eingereichten Antrag ein von Ihnen oder Ihrer Vertretung unterzeichnetes Begleitschreiben, das die Besonderheiten der klinischen Prüfung hervorhebt und auf die Fundstellen der diesbezüglichen Informationen in den weiteren Unterlagen verweist
    • zu jeder Nachreichung ein entsprechendes Begleitschreiben

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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  • Online transactions, Bavaria-wide
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  • Legal bases, Bavaria-wide
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