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Clinical investigations which require a notification

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Changes

  • : Added link to guidance on the content of the Clinical Investigation Plan (CIP) and template for the synopsis of the clinical investigation.
  • : Updated section on what needs to be submitted with a notification with information about cover letter. The document "Overview of submitted documents for MDR notifications" has been updated.

Information regarding investigations of CE-marked medical devices that require a notification to NOMA.

Page contents

    Which clinical investigations require a notification to NOMA?

    ​​​​​​​​​​​​​​​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​ (MDCG 2021-6) (pdf) for guidance on what is considered an invasive or burdensome procedure.

    What needs to be submitted with the notification?

    ​A notification of a clinical investigation must include the documentation listed below. 

    The requirements for the notification, including the content of the documents, are described in MDR Annex XV. 

    For a complete list of ​requirements ​that apply to these clinical investigations, please confer​​ Article 74 (1).​

    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 notification:

    Overview of submitted documents for MDR notifications

    Checklist with an overview of the submitted documents.

    Cover letter

    The cover letter should provide a description of the clinical investigation and of the additional procedures that are invasive or burdensome.

    Notification form

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

    Instructions for use

    Instructions for use of the device.

    Confirmation that the device conforms to regulatory requirements

    This is documented by submitting the Declaration of Conformity (DoC) of the device, and the EC certificate, if applicable.

    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. 

    An overall synopsis of the clinical investigation must be submitted in both Norwegian and English language, either as part of the CIP or as a separate document. The Norwegian and English version of the synopsis must be identical.

    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.

    The reporting obligations that apply for substantial modifications (Art. 75), end ​or halt ​of the clinical investigation (Art. 77) and safety reporting (Art. 80(5) and (6)) must be clearly stated in the respective sections in the CIP. More information can be found on the websites ​​Substantial modifications to clinical investigations, End or temporary halt of a clinical investigation and Safety reporting in clinical investigations​.

     

    MDR Annex XV checklist

    Checklist with an overview of the required information in CIP.

    ​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

    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

    The following must be documented in the CIP or as a separate document, according to MDR Annex XV, Chapter II, Section 4.5: 

    • ​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?

    Until EUDAMED is available the notification must be submitted by email to kki@NOMA.no. The subject heading should include "Clinical investigation notification", name of sponsor and name of 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) using the REK-portal. Required documents by REK KULMU are specified on their website. Documents submitted to both agencies must be identical.

    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 REK KULMU has not issued a negative opinion. 

     

    Contact us

    Unit for medical devices - development and notified body

    (+47) 22 89 77 00

    Questions regarding clinical trials, classification and innovation guidance

    kki@noma.no