1. Which clinical investigations require a notification?

​​​​​​​Clinical investigations which fall under MDR Article 74 (1) require a notification to NoMA. These include clinical investigations to further assess a CE marked device within the scope of its intended use and where the investigation would involve submitting subjects to:

  • ​procedures additional to those performed under normal conditions of use 
  • and those additional procedures are invasive or burdensome. 
Please consult the Q&A regarding clinical investigations​ for guidance on what is considered an invasive or burdensome procedure.


2. What needs to be submitted with the notification?

​A notification of a clinical investigation must include the information listed in the document below: 

Documentation requirements and overview of submitted documents​

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 notification:

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. 

Certificate of conformity and Declaration of conformity 

A Certificate of conformity from the Notified body and a Declaration of conformity from the manufacturer shall be submitted as documentation of the CE mark. 

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. 

How to submit a notification? 

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

An identical notification must be submitted to NoMA and the Regional Committees for Medical and Health Research Ethics (REK) on the same day. The notification to REK is submitted using the REK-portal.

3. When will I receive a decision?

​The sponsor will receive a confirmation from NoMA that the notification has been received. The clinical investigation may commence 30 days after submission of the notification unless the sponsor is informed of otherwise.  

It is a prerequisite that the Regional Committees for Medical and Health Research Ethics (REK) has not issued a negative opinion. 

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Publisert: 23.03.2022

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