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Home / REK KULMU / Clinical investigations of in vitro diagnostic medical devices (IVDR) / Modification application performance studies
  • REK KULMU Comittees
  • Meetings
  • REK KULMU
  • Clinical Trials Regulation (CTR)
    • EU application portal CTIS
    • General requirements and recommendations for a CTR application
      • Modification application CTIS
      • Part I application
      • Part II application (national application)
        • Recruitment
        • Information to study participants and consent form
        • Suitability of the investigator
        • Suitability of the facilities
        • Proof of insurance cover or indemnification
        • Financing and other arrangements
        • Compliance with national requirements on Data Protection
        • Compliance with use of biological samples
          • Use of biological material for future research
  • Clinical investigations of medical devices (MDR)
    • Application to REK for MDR studies
    • Clinical trials of medical device that are subject to application or notification to NoMA
    • Combination trials
    • Storage period of personal data
    • Modification applications to NoMA
  • Clinical investigations of in vitro diagnostic medical devices (IVDR)
    • Application to REK for IVDR studies
    • Performance studies that are subject to application or notification to NoMA
    • Combination trials
    • Storage period of personal data
    • Modification application performance studies
  • Information forms CTR/MDR/IVDR
    • Inclusion of minors in reserach
    • Informed consent forms for broad consent
  • Templates REK KULMU
  • Answers to frequently asked questions

Modification application performance studies

Performance studies that are subject to application or notification to NoMA
For new applications and modification applications to be applied for or notified to NoMA, it is assumed that:

  • Applications to REK and NoMA are submitted on the same day. The application will not be processed until both agencies have received the respective application (or notification)
  • Documents submitted to both agencies must be identical
  • If application documents submitted to REK need to be revised after validation of the application by NoMA, updated documents must be submitted to REK via the REK portal
  • REK processes applications continuously after NoMA has completed the validation of the application/notification.

 

It is the applicant/sponsor’s responsibility to ensure that NoMA and REK always have access to updated and identical documents.

The application must be approved by REK and the necessary approvals from NoMA must be in place before the study, or the modifications, can be initiated.

Important shortcuts

  • DMPs website
  • Templates REK KULMU
  • Regulatory guide for clinical trials according to the MDR (only available in Norwegian)
  • DMPs website
  • Templates REK KULMU
  • Regulatory guide for clinical trials according to the MDR (only available in Norwegian)
Illustrasjon av leger

Current messages

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  • 20. Jun 2025

Update

New layout in the REC portal

The REK portal has undergone a necessary upgrade that involves some changes in appearance and layout. Here is an...

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  • 14. Feb 2025

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Updated templates for informed consent forms

There are updated templates for informed consent forms for studies that are regulated by CTR, MDR or IVDR at...

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  • 24. Nov 2024

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REK

General inquiries should be directed to the REK in your geographical region.

REK KULMU

For questions regarding the ethical assessment of clinical trials under CTR, MDR, and IVDR, please contact via email: rek-kulmu@medisin.uio.no

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  • About REK / REK KULMU
    • About REK
    • About REK KULMU
    • Prosjektregister
    • Postjournal
  • Application form
    • Prosjektsøknad
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  • About REK / REK KULMU
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  • Application form
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Prosjektregister

REK

  • About REC

REK KULMU

  • REK KULMU Comittees
  • Meetings
  • REK KULMU
  • Clinical Trials Regulation (CTR)
    • EU application portal CTIS
    • General requirements and recommendations for a CTR application
      • Modification application CTIS
      • Part I application
      • Part II application (national application)
        • Recruitment
        • Information to study participants and consent form
        • Suitability of the investigator
        • Suitability of the facilities
        • Proof of insurance cover or indemnification
        • Financing and other arrangements
        • Compliance with national requirements on Data Protection
        • Compliance with use of biological samples
          • Use of biological material for future research
  • Clinical investigations of medical devices (MDR)
    • Application to REK for MDR studies
    • Clinical trials of medical device that are subject to application or notification to NoMA
    • Combination trials
    • Storage period of personal data
    • Modification applications to NoMA
  • Clinical investigations of in vitro diagnostic medical devices (IVDR)
    • Application to REK for IVDR studies
    • Performance studies that are subject to application or notification to NoMA
    • Combination trials
    • Storage period of personal data
    • Modification application performance studies
  • Information forms CTR/MDR/IVDR
    • Inclusion of minors in reserach
    • Informed consent forms for broad consent
  • Templates REK KULMU
  • Answers to frequently asked questions
  • About REK / REK KULMU
    • About REK
    • About REK KULMU
    • Prosjektregister
    • Postjournal
  • Application form
    • Prosjektsøknad
    • Generell biobank
    • Dispensasjon fra taushetsplikt annen forskning
    • CTIS
  • Templates REK KULMU
  • EN
  • NO
  • About REK / REK KULMU
    • About REK
    • About REK KULMU
    • Prosjektregister
    • Postjournal
  • Application form
    • Prosjektsøknad
    • Generell biobank
    • Dispensasjon fra taushetsplikt annen forskning
    • CTIS
  • Templates REK KULMU
  • EN
  • NO
Project register

REK

  • About REC

REK KULMU

  • REK KULMU Comittees
  • Meetings
  • REK KULMU
  • Clinical Trials Regulation (CTR)
    • EU application portal CTIS
    • General requirements and recommendations for a CTR application
      • Modification application CTIS
      • Part I application
      • Part II application (national application)
        • Recruitment
        • Information to study participants and consent form
        • Suitability of the investigator
        • Suitability of the facilities
        • Proof of insurance cover or indemnification
        • Financing and other arrangements
        • Compliance with national requirements on Data Protection
        • Compliance with use of biological samples
          • Use of biological material for future research
  • Clinical investigations of medical devices (MDR)
    • Application to REK for MDR studies
    • Clinical trials of medical device that are subject to application or notification to NoMA
    • Combination trials
    • Storage period of personal data
    • Modification applications to NoMA
  • Clinical investigations of in vitro diagnostic medical devices (IVDR)
    • Application to REK for IVDR studies
    • Performance studies that are subject to application or notification to NoMA
    • Combination trials
    • Storage period of personal data
    • Modification application performance studies
  • Information forms CTR/MDR/IVDR
    • Inclusion of minors in reserach
    • Informed consent forms for broad consent
  • Templates REK KULMU
  • Answers to frequently asked questions