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Performance studies which require an application

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  • : Updated section on what needs to be included in the application with information about cover letter.

Information regarding performance studies which require an application to NOMA, including how to apply and when you will receive a decision.

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    Which studies require an application to NOMA?

    ​​​​​​​​​​​​​​​​​​​​​​An application to NOMA is required for any performance study:

    • in which surgically invasive sample-taking is done only for the purpose of the performance study (IVDR Article 58 (1) a)
    • that is a clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment (IVDR Article 58 (1) b)
    • where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies (IVDR Article 58 (1) c)
    • involving companion diagnostics* (IVDR Article 58 (2))

    *Performance studies involving companion diagnostics where only left-over samples are used do not have to be applied for but shall instead be notified to NOMA. Information on how to submit the notification can be found on our website ​​Performance studies which require a notification to NOMA​.

    What needs to be included in the application

    The documentation to be submitted in the application is listed below. The requirements for the documentation are further described in IVDR Annex XIII and XIV. 

    We recommend using ISO 20916:2019 «In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice»​ to understand the documentation requirements in IVDR, and how to fulfil them.

    Below you will find a description of the documents that are mandatory in the application:

    Overview of submitted documents for IVDR applications

    Checklist with an overview of the documents to be submitted.

    Cover letter

    The cover letter should provide a description of the performance study and information on the development phase. If the study is a combined study, information should be given on the relation of the performance study to the clinical trial of the medicinal product. Please provide information on whether the application for the clinical trial of the medicinal product has already been submitted. 

    Application form

    The application form (‘Application-Notification form’)  must be completed and signed. Attachment to part 3, 4 and 5 of the application form is used if necessary.

    IVDR Annex XIV check list

    Checklist with an overview of the necessary information in IB and CPSP.

    Investigator's brochure (IB)

    The investigator's brochure (IB) shall contain the information on the device 
    for performance study that is relevant for the study and available at the 
    time of application. The IB shall fulfil the requirements of IVDR Annex XIV, Chapter I, Section 2 and preferably follow its layout with regards to subtitles. 

    The IB should be prepared in accordance with good study practice as described in Annex C of the standard ISO 20916:2019.

    The list referred to in point 2.7 is preferably presented in the format of the GSPR and standards check list (word) (also found as an Annex in the MDCG 2022-19 guidance). Compliance with the standards and the common specifications used must be indicated as partial or full. 

    Clinical Performance Study Plan

    The CPSP shall fulfil the requirements of IVDR, Annex XIII, Part A, Section 2.3.2 and preferably follow its layout with regards to subtitles. 

    The CPSP should be prepared in accordance with good study practice as described in Annex B of the standard ISO 20916:2019.

    Statement of conformity

    A signed statement that the device in question conforms to the general safety and performance requirements laid down in Annex I apart from the aspects covered by the clinical performance study. The statement must be dated and signed by the legal or natural person responsible for the manufacture of the device for the performance study. Cf. IVDR, Annex XIV, Chapter I, point 4.1.

    Proof of insurance cover of the subjects of the study

    The documentation shall confirm that any damage that may occur during the performance study is covered by the insurance. It can be a copy of email correspondence with The Norwegian System of Patient Injury Compensation (NPE), or a copy of insurance certificates from an insurance company.

    Patient information document and informed consent form

    Templates for the patient information document and informed consent form can be found on the Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (REK KULMU) website.

    Description of the protection and confidentiality of personal data

    The following must be described in CPSP or in a separate document in accordance with IVDR Annex XIV, Chapter I, section 4.5:

    • The organisational and technical arrangements that will be implemented to 
      avoid unauthorised access, disclosure, dissemination, alteration or loss 
      of information and personal data processed.
    • A description of measures that will be implemented to ensure confidentiality of records and personal data of subjects.
    • A description of measures that will be implemented in case of a data 
      security breach in order to mitigate the possible adverse effects.
    Confirmation of suitability of investigational site(s) and investigation team​

    The sponsor shall document that the principal investigator(s) and the investigational site(s) are suitable to conduct the performance study in accordance with the clinical performance study plan (CPSP)​.  

    The competency of the principal investigator (PI) shall be documented by submitting his or her CV. This applies to the principal investigator at each investigation site. 

    ​Suitability of the investigation site shall be documented by a statement from the person in charge of the investigation site. 

    Forms for application

    How to submit an application

    Until EUDAMED is available, the application must be submitted to the Norwegian Medical Products Agency (NOMA) by email to kki@noma.no. The subject heading should include “Performance study application” and the name of the sponsor and the device. 

    The application to NOMA and the Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (REK KULMU) must be submitted on the same day. The application to REK KULMU is submitted using the REK-portal. Required documents by REK KULMU are specified on their website. Documents submitted to both authorities must be identical. 

    If application documents submitted to REK KULMU have been revised during the validation procedure at NOMA, then the revised documents must be submitted to REK KULMU. It is the responsibility of the sponsor to ensure that both NOMA and REK KULMU have access to updated and identical application documentation.

    When will I receive a decision?

    The application processing time is contingent on whether the application must be validated or authorised by NOMA. This depends on which IVDR article the performance study falls under, and whether the specimen collection represents a major clinical risk to the subjects of the study.

    Application that will be validated

    For performance studies that fall under IVDR Article 58 (1) a (i.e., surgically invasive sample-taking done only for the purpose of the performance study) and the specimen collection does not represent a major clinical risk to the subject of the study, NOMA will validate the application. 

    The application is valid if:

    • The application is complete, cf. the documentation referred to in IVDR Annex XIV, and

    • The performance study is within the scope of IVDR

    The sponsor will be notified as to whether the performance study application is considered valid or not within 15 days of NOMA receiving the application. The sponsor may start the performance study after the validation date of the application, provided that a negative opinion has not been issued by REK KULMU. 

    If the application is not valid, the sponsor will get an additional 10 days to comment or to complete the application. The sponsor can request an additional 20 days to complete the application if necessary. The sponsor will receive a final decision of the application within 10 days of resubmission. The application will be rejected if it is still invalid. The sponsor can appeal the decision.

    Applications that will be validated and assessed

    NOMA will perform an assessment of the application for the following types of studies: 

    • ​Performance studies that fall under IVDR Article 58 (1) a (surgically invasive sample-taking is done only for the purpose of the performance study) and where the specimen collection represents a major clinical risk to the subject of the study

    • Performance studies that fall under:

      • IVDR Article 58 (1) b (clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment),

      • IVDR Article 58 (1) c (where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies),
      • IVDR Article 58 (2) (involving companion diagnostics), except if only left-over samples are used.

    The application will first be validated according to the same procedure and deadlines as described above. Valid applications will be evaluated against the criteria of IVDR Article 67. The sponsor will receive a decision on the application 45 days after the date on which the application was considered valid, except:

    • If NOMA requests additional information from the sponsor. The processing time is paused whilst waiting for a response from the sponsor. 

    • If there is a need to consult experts. In this case the processing time may increase by up to 20 days. The sponsor will be notified if consultation with experts is necessary. 

    The performance study may commence once the sponsor has received an authorisation from NOMA, provided that REK KULMU has not issued a negative opinion. If an authorisation is refused, the sponsor may appeal the decision.​​

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