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