The sponsor must determine: 1) if his investigation falls under the definition of a
clinical investigation and 2) if his device falls under the
definition of a medical device. If the answer is yes to both questions, then the sponsor must determine if the investigation requires application or notification to the Norwegian Medicines Agency (NoMA), or if it is subject to other formal requirements.
Clinical investigation as a basis for clinical evaluation
A clinical evaluation is required for all medical devices. It is a continuous process that involves assessment of the clinical data for the device to determine if the device complies with the regulatory requirements with regards to clinical performance and safety. A clinical evaluation can be based on:
- one or more clinical investigations of the medical device in question,
- one or more clinical investigations published in the scientific literature of medical devices for which equivalence to the device in question can be demonstrated (cf. MDR annex XIV, Part A, point 3).
Clinical investigation requirements are also dependent on the device classification or product type. Detailed information on the requirements and what can be used as a basis for clinical evaluation is described in MDR Article 61. The manufacturer must decide whether there is a need to conduct a clinical investigation, or whether clinical evaluation can be based on existing clinical data.
Does the investigation require application or notification?
Clinical investigations that require application
An application must be submitted to NoMA if the project fulfils the definition of a clinical investigation of a medical device and if; 1) the medical device is not CE marked as a medical device, or 2) if the device is CE marked but will be investigated outside the scope of its intended purpose as defined by the manufacturer. An application must be submitted both for investigations that are performed with the intent of future conformity assessment or CE marking as a medical device, and for investigations that are performed without the intent of future conformity assessment or CE marking. This means that you must apply to NoMA and receive approval before the clinical investigation can commence. Please see our detailed information regarding how to submit an application for a clinical investigation of a medical device.
Clinical investigations that require notification
A notification to NoMA is required if the clinical investigation is performed using a CE marked device, and the investigation involves submitting subjects to procedures additional to those performed under the normal conditions of use of the device, and those additional procedures are invasive or burdensome. Notifiable investigations are described in MDR Article 74. For guidance on what procedures are considered invasive or burdensome, please see the EU Commission’s Q&A. If the clinical investigation is notifiable, then a notification must be sent to NoMA. The clinical investigation may commence 30 days after submission of the notification unless the sponsor is informed otherwise by NoMA. Please see our detailed information regarding how to submit a notification for a clinical investigation of a medical device.
Clinical investigations that do not require application nor notification
There are some clinical investigations which do not require application or notification but may still be subject to requirements in the regulations for medical devices (MDR article 82). This applies to clinical investigations where the safety or performance of the medical device is examined, provided that the purpose of the investigation falls under the definition of clinical investigation of a medical device. For more information, please see our pages for clinical investigations that do not require application or notification.
Feasibility studies are not subject to these requirements if a CE-marked medical device is used (within the manufacturer's intended purpose), provided that it is the method that is examined and not the safety or performance of the device itself.
Which clinical investigations must be evaluated by the Regional Committees for Medical and Health Research Ethics (REK)?
All clinical investigations of medical devices must be evaluated and approved by the REK. This also applies to clinical investigations that do not require application or notification to NoMA.
Additional national requirements for clinical investigations
Additional national requirements have been introduced for clinical investigations in Norway. These requirements are described in Forskrift for medisinsk utstyr §16 and §18. You may read more about this in our guidance to the new regulations (in norwegian).
The additional national requirements state that synopses for clinical investigations must be submitted in both Norwegian and English language (cf. §16 in Forskrift for medisinsk utstyr) and that clinical investigations that fall under Article 82 of the MDR must also submit an application (cf. §18 in Forskrift for medisinsk utstyr).
Key concepts and definitions
What is a clinical investigation?
A ‘clinical investigation’ is any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device. The definition is stated in MDR Article 2 (45).
A clinical investigation should be prepared in accordance with good clinical practice as described in the standard
ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clincal practice.
What is MDR Article 62
MDR Article 62 (1) concerns clinical investigations of medical devices carried out as part of the clinical evaluation for conformity assessment purposes, for one or more of the following purposes:
- to establish and verify that, under normal conditions of use, a device is designed, manufactured, and packaged in such a way that it is suitable for one or more of the specific purposes listed in point (1) of Article 2, and achieves the performance intended as specified by its manufacturer.
- to establish and verify the clinical benefits of a device as specified by its manufacturer.
- to establish and verify the clinical safety of the device and to determine any undesirable side-effects, under normal conditions of use of the device, and assess whether they constitute acceptable risks when weighed against the benefits to be achieved by the device.
For such clinical investigations, an application must be submitted to NoMA prior to commencement.
What is MDR Article 74?
MDR Article 74 concerns clinical investigations that are to be conducted to further assess, within the scope of its intended purpose, a device which already bears the CE marking in accordance with MDR Article 20 (1). If the clinical investigation will involve submitting subjects to procedures additional to those performed under normal conditions of use of the device and those additional procedures are invasive or burdensome, the sponsor shall notify NoMA at least 30 days prior to its commencement. The relevant provisions of Annex XV shall apply to investigations with regards to clinical follow-up after the equipment has been placed on the market. Please see our pages regarding Clinical investigations which require notification to NoMA for information regarding what needs to be submitted for such investigations in Norway.
What is MDR Article 82?
In Norway, national provisions have been introduced in
Forskrift om medisinsk utstyr §18, stating that clinical investigations of medical devices that are not performed pursuant to any of the purposes listed in MDR Article 62 (1) and where:
is not CE marked as a medical device, or
is a CE marked device that will be used outside of the scope of its intended purpose as stated by the manufacturer
shall be subject to the requirements of MDR Article 62, and consequently requires an application to NoMA before commencement.
MDR Article 82 also includes clinical investigations that do not require application or notification to NoMA. These investigations must still meet formal requirements in the regulation of medical devices. For more information, please see our pages for investigations that do not require application or notification.