Clinical investigations which require an application to NoMA

1. Which investigations require an application

An application is required if the device under investigation is:

not CE marked, or
CE marked, but will be investigated outside of the scope of its intended purpose

and where the investigation falls under the definition of a clinical investigation, and the device falls under the definition of a medical device.

Both investigations conducted for the purpose of future conformity assessment or CE marking as a medical device (Article 62(1) of MDR), and investigations conducted for other purposes (Article 82 in MDR) require application.

What about devices that are CE marked and will be investigated within the scope of their intended purpose?

Medical devices that are CE marked and investigated within the scope of their intended purpose (post-market clinical follow-up studies/PMCF) generally do not require application or notification to NoMA. Such studies will only require notification to NoMA if the investigation involves additional procedures which are invasive or burdensome to the subjects as described in MDR article 74.1.

2. What needs to be included in the application?

A clinical investigation application must include the documentation listed in the document below:

Overview of submitted documents for applications

The required documentation is based on MDR Annex XV, chapter II.

We recommend using ISO 14155: 2020 "Clinical investigation of medical devices for human subjects - Good clinical practice" to understand the documentation requirements in MDR, and how to fulfil them.

Below you will find instructions on how to compile some of the documents that are mandatory in the application:

Investigator’s Brochure (IB)

The Investigator's Brochure (IB) shall contain the clinical and non-clinical information about the medical device under investigation that is available at the time of application. The IB shall fulfil the requirements of MDR Annex XV, Chapter II, Section 2 and preferably follow its layout with regards to subtitles.

The list referred to in point 2.7 can be fulfilled by filling out and submitting the «GSPR and standards check list». Compliance with the standards and the common specifications used must be indicated as partial of full.

The IB shall also comply with the requirements of Annex B of ISO 14155:2020.

Clinical Investigation Plan (CIP)

The CIP shall fulfil the requirements of MDR, Annex XV, chapter II, Section 3 and preferably follow its layout with regards to subtitles.

The CIP shall also comply with the requirements of Annex A of ISO 14155:2020.

Synopses for the clinical investigations must be submitted in both Norwegian and English language, either as part of the CIP or as a separate document.

Statement of Conformity

The statement shall be written in accordance with MDR Annex XV, Chapter II, Section 4.1. Please feel free to use our template for correct wording.

The statement must be dated and signed by the legal or natural person responsible for the manufacture of the medical device under investigation.

Confirmation on the suitability of the 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 clinical investigation in accordance with the Clinical Investigation Plan.

The competency of the principal investigator 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.

Proof of insurance cover of the subjects

The sponsor shall submit documentation indicating which patient injury insurance that covers the subjects of the clinical investigation. 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 Norsk pasientskadeerstatning (NPE), or a copy of insurance certificates from an insurance company.

Patient information document and informed consent form

Template 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

Included in the CIP, or as a separate document, the following shall be documented:

The organizational and technical measures that will be implemented to avoid unauthorized access, disclosure, dissemination, alteration or loss of information and personal data that is being processed.
A description of measures that will be implemented to ensure confidential treatment of the subjects' records and personal data.
A description of measures that will be implemented in the event of a breach of data security to limit possible negative effects.

3. How to submit an application?

The application must be submitted by email to meddev-no@noma.no. The subject heading should include “Clinical investigation application, name of sponsor and name of device”.

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.

4. When will I receive a decision?

The application processing time is dependent on the risk profile of the device.

Application for an investigation of a low-risk device

If the investigational device is a class I, non-invasive class IIa or non-invasive class IIb medical device, then NoMA will perform a validation of the application. The validation process will determine if the application is valid. The clinical investigation can commence once the sponsor has been notified that the application is valid, provided that the Regional Committees for Medical and Health Research Ethics (REK) has not issued a negative opinion.

The application is valid if:

The application is complete cf. MDR Annex XV, Cahpter II, and
The clinical investigation is within the scope of MDR

The sponsor will receive a response to whether the application is valid or not within 15 days.

If the application is not valid, the sponsor will get an additional 10 days to comment or improve 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.

Application for an investigation of a high-risk device

If the investigational device is either an invasive class IIa, an invasive class IIb or class III device, the clinical investigation must have an authorisation by NoMA before commencement.

The application will first be validated according to the same procedure and deadlines as listed above for low-risk devices. Valid applications will be evaluated against the criteria of MDR article 71. 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 up to 20 days. The sponsor will be notified if the consultation by external experts is necessary.

The clinical investigation 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.