Post-market performance follow-up (PMPF) studies
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- : Updated section on what needs to be submitted with a notification with information about cover letter.
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Which PMPF studies require a notification to NOMA?
PMPF studies as described in IVDR article 70 (1) shall be notified to NOMA. These are performance studies where a device which already bears the CE marking will be further assessed, within the scope of its intended purpose, and where:
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subjects are submitted to procedures additional to those performed under the normal conditions of use of the device, and
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those additional procedures are invasive or burdensome
PMPF studies which do not involve procedures as described above do not have to be notified to NOMA. Where a performance study is to be conducted to assess a device which already bears the CE marking, outside the scope of its intended purpose, the sponsor must consider if the study requires an application to NOMA. See our website about Performance studies which require an application to NOMA.
What needs to be submitted with a notification?
The documentation to be submitted with the PMPF notification is listed below. The requirements for the documentation are further described in IVDR Annexes XIII and XIV. Also confer IVDR Article 70 (1) regarding other requirements for PMPF studies.
We recommend using ISO 20916:2019 «In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice» to understand the documentation requirements in IVDR, and how to fulfil them.
Overview of submitted documents for IVDR notifications
Checklist with an overview of the submitted documents.
Cover letter
The cover letter should provide a description of the performance study and information on the development phase. If the study is a combined study, information should be given on the relation of the performance study to the clinical trial of the medicinal product. Please provide information on whether the application for the clinical trial of the medicinal product has already been submitted.
Notification form
The notification form (‘Application-Notification form’) must be completed and signed. Appendixes for part 3, 4 and 5 of the notification form is used if necessary.
Instructions for use (IFU)
Instructions for use for the device.
Confirmation that the device conforms to regulatory requirements
This is documented by submitting the Declaration of Conformity for the device, and EC certificate, if applicable.
Clinical performance study plan
The clinical performance study plan (CPSP) shall fulfil the requirements of IVDR, Annex XIII, Part A, point 2.3.2, and preferably follow its layout with regards to subtitles.
The content of the CPSP should also comply with best pratice as described in Annex B i ISO 20916:2019.
The requirements regarding substantial modifications (Article 71), end or temporary halt of the study (Article 73) and safety reporting (Article 76) must be clearly identified in the respective sections of the CPSP. More information can be found on our website Substantial modifications to a performance study, End or temporary halt of a performance study and Safety reporting in performance studies.
IVDR Annex XIII check list for CPSP
Checklist with an overview of the required information in the CPSP.
Confirmation of suitability of 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 performance study in accordance with the clinical performance study plan (CPSP).
The competency of the principal investigator (PI) 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 performance study.
The documentation shall confirm that any damage that may occur during the performance study 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
Templates 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
See IVDR, Annex XIV, Chapter I, point 4.5 for more information.
Forms for notification
How to submit a notification?
Until EUDAMED is available, the notification must be submitted to the Norwegian Medical Products Agency by e-mail to kki@noma.no. The subject heading should include “PMPF study notification” 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) using the REK-portal. For more information, see REK KULMUs website. Documents submitted to both authorities must be identical.
When will I recive a decision?
The sponsor will receive a confirmation from NOMA that the notification has been received. The PMPF study may commence 30 days after submission of the notification unless the sponsor is informed otherwise.
It is a prerequisite that REK KULMU has not issued a negative opinion.