Performance studies that must be applied for 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. In order to notify us of such a study send an e-mail to meddev-no@noma.no with a short description of the performance study.

​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. 

• Application form, d​​uly filled in. 

• Overview of submitted documents, duly filled in.

• The IVDR Annex XIV check list, duly filled in.

• Investigator’s brochure (IB). The IB shall contain the information listed in IVDR, Annex XIV, Chapter I, Section 2.

• GSPR check list, duly filled in.

• A performance study plan, in accordance with IVDR, Annex XIII, Part A, point 2.3.2. 

• 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 Regional Committees for Medical and Health Research Ethics (REK) website.

• Description of the protection and confidentiality of personal data. See IVDR, Annex XIV, Chapter I, point 4.5 for more information.​​​

​The application must be submitted by email to meddev-no@noma.no. The subject heading should include “Performance study application, ”. 

The application to NoMA and the Regional Committees for Medical and Health Research Ethics (REK) must be submitted on the same day. The application to REK is submitted using the REK-portal. Required documents by REK are specified on their website. Documents submitted to both authorities must be identical. 

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

​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.

Applications 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 wi​ll 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. 

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. 

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 NoMA or REK has the need to consult external experts. In this case the processing time may increase by up to 20 days. The sponsor will be notified if consultation with external experts is necessary. 

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