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Applying for approval to conduct clinical trials of medical devices

Source: Zuständigkeitsfinder Schleswig-Holstein (Linie6Plus)

Service Description

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

Before a new medical device is placed on the market, clinical trials may have to be carried out in order 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 carried out on volunteers or patients. Such a test is necessary if clinical data from the literature, from clinical experience or from previously conducted clinical trials are not sufficient 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 to support a conformity assessment procedure or
  • should serve in the future

and

  • which are conducted with investigational devices that are not yet authorized to bear the CE mark, or
  • are used outside the intended purpose defined by the manufacturer.


You can find out which ethics committee is responsible in your case in 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 processed via the DMIDS; these other clinical trials also require an evaluation by an ethics committee before they are conducted.

The decisive date for the start of the clinical trial is the date on which the first trial participant has legally consented to the trial after all requirements for the start of the clinical trial have been met.


Process flow

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

  • Access 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 complete the application using the "Registration" option.
  • Submit your application via the DMIDS.
  • As part of the sequential application procedure, the application is first forwarded to the responsible ethics committee and can only be sent to the responsible higher federal authority once the assessment has been completed.
  • In the event of formal deficiencies, you will receive a letter of deficiency with a request to submit the missing documents.
  • As soon as the BfArM has received the complete application documents, you will receive a confirmation of receipt of the correct application.
  • For applications for clinical trials, 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 will review your application and the documents submitted.
  • The responsible ethics committee will inform the BfArM of its decision. Irrespective of this, you must subsequently submit the opinion of the Ethics Committee to the BfArM.
Requirements

In order 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 device or the documents submitted, in particular the protocol and the investigator's manual, must correspond to the current state of scientific knowledge
  • the clinical trial must be suitable for providing evidence of the safety, performance characteristics or benefit of the device for the trial participants or patients
  • the 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 guaranteed and takes precedence over all other interests, and
    • the clinical data obtained are scientifically sound, reliable and robust
  • an independent ethics committee must have ethically reviewed the clinical trial in advance and approved the trial
  • The following vulnerable groups are particularly protected:
    • Persons who are not capable of giving consent themselves
    • minors
    • Pregnant or breastfeeding women
    • Persons performing compulsory military service
    • Persons in prison
    • 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 benefit justifies the foreseeable risks and disadvantages and compliance with this condition is constantly monitored
  • the subject's right to physical and mental integrity, privacy and protection of their personal data is respected
  • the clinical trial is planned in such a way that it is associated with as little pain, discomfort, anxiety and all other foreseeable risks as possible for the trial participants and both the risk threshold and the extent of exposure are specifically defined in the clinical trial protocol and constantly reviewed
  • the responsibility for the medical care of the trial subjects lies with a physician with appropriate qualifications or any other person authorized to provide appropriate patient care in the context of a clinical trial
  • the trial subjects or, where applicable, their legally authorized representatives are not subjected to any undue influence, such as financial influence, in order to induce them to participate in the clinical trial
  • the clinical trial may only be conducted by qualified specialist 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 device is to be used
  • the investigational devices must be shown to comply with the essential European safety and performance requirements
  • all precautions to protect the health and safety of the trial subjects must have been taken
  • the risk minimization solutions you use must comply with EU law and, if they do not, the risk minimization 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 obtained during the clinical trial must be reliable and robust
  • for devices for sterile use, the manufacturer's sterilization procedures must be validated
  • components of human or animal origin and substances that may be considered medicinal products under EU law must be demonstrably safe, of high quality and useful
  • Medical devices intended for clinical trials must bear the label "for clinical trials only"
    • The labeling must
      • ensure the protection of trial subjects, users or third parties and traceability,
      • enable the identification of the individual medical device and
      • ensure proper use of the medical device.
Which documents are required?
  • 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
What are the fees?

Fee: 3000,00 - 9900,00 EUR
Payment in advance: no
for an application for approval of a clinical trial

What deadlines do I have to pay attention to?

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 invalid. This period can be extended to a maximum of 20 days.

If the BfArM requests additional information from you during the content review phase, this 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 duration

Processing time: 10 Days
Processing time (normally) for checking whether the application and documents are complete and fall within the scope of the relevant EU regulation

Processing time: 5 Days
Processing time for notification that, following receipt of the opinion or the requested additional information, the clinical trial falls within the scope of the relevant EU Regulation and the application is complete

Processing time: 45 Days
Processing time for the subsequent content review

Legal basis
Appeal
  • Appeal. You will find explanations on how to lodge an objection in the notification of your application.
Applications / forms
  • Forms: No
  • Written form required: No
  • Informal application possible: No
  • Personal appearance necessary: No
  • Online procedure possible: Yes
What else should I know?

In accordance with Article 70(1) of Regulation (EU) 2017/745 (MDR), the application must be submitted via the electronic system in accordance with Article 73 MDR. This system is EUDAMED (European Database on Medical Devices), which is currently still being created. Until the corresponding functionalities for the submission of applications 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.

Author
Forwarding service: Deep link to the original portal

The text was automatically translated based on the German content.

Teaser

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

Process flow

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

  • Access 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 complete the application using the "Registration" option.
  • Submit your application via the DMIDS.
  • As part of the sequential application procedure, the application is first forwarded to the responsible ethics committee and can only be sent to the responsible higher federal authority once the assessment has been completed.
  • In the event of formal deficiencies, you will receive a letter of deficiency with a request to submit the missing documents.
  • As soon as the BfArM has received the complete application documents, you will receive a confirmation of receipt of the correct application.
  • For applications for clinical trials, 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 will review your application and the documents submitted.
  • The responsible ethics committee will inform the BfArM of its decision. Irrespective of this, you must subsequently submit the opinion of the Ethics Committee to the BfArM.

Requirements

In order 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 device or the documents submitted, in particular the protocol and the investigator's manual, must correspond to the current state of scientific knowledge
  • the clinical trial must be suitable for providing evidence of the safety, performance characteristics or benefit of the device for the trial participants or patients
  • the 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 guaranteed and takes precedence over all other interests, and
    • the clinical data obtained are scientifically sound, reliable and robust
  • an independent ethics committee must have ethically reviewed the clinical trial in advance and approved the trial
  • The following vulnerable groups are particularly protected:
    • Persons who are not capable of giving consent themselves
    • minors
    • Pregnant or breastfeeding women
    • Persons performing compulsory military service
    • Persons in prison
    • 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 benefit justifies the foreseeable risks and disadvantages and compliance with this condition is constantly monitored
  • the subject's right to physical and mental integrity, privacy and protection of their personal data is respected
  • the clinical trial is planned in such a way that it is associated with as little pain, discomfort, anxiety and all other foreseeable risks as possible for the trial participants and both the risk threshold and the extent of exposure are specifically defined in the clinical trial protocol and constantly reviewed
  • the responsibility for the medical care of the trial subjects lies with a physician with appropriate qualifications or any other person authorized to provide appropriate patient care in the context of a clinical trial
  • the trial subjects or, where applicable, their legally authorized representatives are not subjected to any undue influence, such as financial influence, in order to induce them to participate in the clinical trial
  • the clinical trial may only be conducted by qualified specialist 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 device is to be used
  • the investigational devices must be shown to comply with the essential European safety and performance requirements
  • all precautions to protect the health and safety of the trial subjects must have been taken
  • the risk minimization solutions you use must comply with EU law and, if they do not, the risk minimization 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 obtained during the clinical trial must be reliable and robust
  • for devices for sterile use, the manufacturer's sterilization procedures must be validated
  • components of human or animal origin and substances that may be considered medicinal products under EU law must be demonstrably safe, of high quality and useful
  • Medical devices intended for clinical trials must bear the label "for clinical trials only"
    • The labeling must
      • ensure the protection of trial subjects, users or third parties and traceability,
      • enable the identification of the individual medical device and
      • ensure proper use of the medical device.

Which documents are required?

  • 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

What are the fees?

Fee: 3000,00 - 9900,00 EUR
Payment in advance: no
for an application for approval of a clinical trial

What deadlines do I have to pay attention to?

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 invalid. This period can be extended to a maximum of 20 days.

If the BfArM requests additional information from you during the content review phase, this 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 duration

Processing time: 10 Days
Processing time (normally) for checking whether the application and documents are complete and fall within the scope of the relevant EU regulation

Processing time: 5 Days
Processing time for notification that, following receipt of the opinion or the requested additional information, the clinical trial falls within the scope of the relevant EU Regulation and the application is complete

Processing time: 45 Days
Processing time for the subsequent content review

Legal basis

Appeal

  • Appeal. You will find explanations on how to lodge an objection in the notification of your application.

Applications / forms

  • Forms: No
  • Written form required: No
  • Informal application possible: No
  • Personal appearance necessary: No
  • Online procedure possible: Yes

What else should I know?

In accordance with Article 70(1) of Regulation (EU) 2017/745 (MDR), the application must be submitted via the electronic system in accordance with Article 73 MDR. This system is EUDAMED (European Database on Medical Devices), which is currently still being created. Until the corresponding functionalities for the submission of applications 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.

Author

Forwarding service: Deep link to the original portal

The text was automatically translated based on the German content.

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