Performance studies which require an application
Which studies require an application to NOMA?
An application to NOMA is required for any performance study:
a) in which surgically invasive sample-taking is done only for the purpose of the performance study
b) that is a clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment
c) where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies,
d) involving companion diagnostics*
*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 Annexes XIII and XIV in the IVDR.
Overview of submitted documents for IVDR applications
Checklist with an overview of the documents to be submitted.
The application form (‘Application-Notification form’) must be filled in 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 can be provided by filling out and submitting the GSPR and standards check list (word). 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 clinical investigation 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
See IVDR, Annex XIV, Chapter I, point 4.5 for more information.
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.
How to submit an application
The application must be submitted by email to email@example.com. The subject heading should include “Performance study application”.
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 updated 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 shall be validated or authorised by NOMA. This depends on which category a to d 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
If the study is in category 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 performance study should be applied for cf. Art 58 in the IVDR
The application is complete, cf. the documentation referred to in Annex XIV of the 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 immediately 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 in category a (surgically invasive sample-taking 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 in categories b, c, or d (b: clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment; c: where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies; d: 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 Article 67 in the IVDR. The application will also be evaluated by REK KULMU.
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.