Clinical investigations which require an application

Which clinical investigations require an application to NOMA?

​​​​​​​​​​​​​​​​​​​​​​​​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. 

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

Guidance on whether the investigation falls within the scope of MDR, and whether it requires an application or notification, can be found under Introduction to clinical investigations of medical devices.

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 MDR Annex XV.

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 a description of the documents that are mandatory in the application:

Overview of submitted documents for MDR applications

Checklist with an overview of the documents to be submitted.

Cover letter

Please use the template provided by NOMA.

Application form

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

MDR Annex XV checklist

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

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

The European Commission has published a guidance document on the content of the IB, with a corresponding checklist, cf. MDCG 2024-5 Guidance on the Investigator’s Brochure content and Appendix A of the MDCG 2024-5. 

The list referred to in point 2.7 is preferably presented in the format of the GSPR and standards check list (also found as an annex in the MDCG 2021-8 guidance). Compliance with the standards and the common specifications used must be indicated as partial of full. 

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. 

The European Commission has published a guidance document on the content of the CIP, cf. MDCG 2024-3 Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices. A template for the synopsis of the clinical investigation is included in the guidance, cf. MDCG 2024-3 Appendix A Clinical Investigation Plan Synopsis Template.

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 Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (REK KULMU) 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. 

Forms for application

How to submit an application?

Until Eudamed is available the application must be submitted by email to kki@noma.no. The subject heading should include "Clinical investigation application" and the name of the sponsor and the device. 

On the same day an application must be submitted to the Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (REK KULMU). The application to REK KULMU is submitted using the REK-portal. Documents required 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, 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.