Introduction to clinical investigations of medical devices

Clinical investigation as a basis for clinical evaluation

A clinical evaluation is required for all medical devices. The clinical evaluation can be based on clinical investigations of the medical device in question, and/or clinical investigations of equivalent devices. 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. Detailed information on the requirements and what can be used as a basis for clinical evaluation is described in MDR Article 61.

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". "Device" includes medical devices, accessories for medical devices, and products listed in 
Annex XVI, cf. MDR Article 1 (4). 

Does the investigation fall within the scope of MDR?

The investigation falls within the scope of MDR if the following conditions are fulfilled:

1. The product being investigated is a medical device or an accessory for a medical device according to the definitions in MDR Articles 2 (1) and 2 (2), or is investigated for one of the purposes covered by these definitions​.
   More information about qualification of medical devices an accessories.
2. ​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​The investigation falls under the definition of a clinical investigation in MDR Article 2 (45), referred to above. 

Clinical investigations of products listed in Annex XVI are also covered by MDR.

If the investigation falls within the scope of MDR, the sponsor must determine if the investigation requires an application or a notification to the Norwegian Medical Products Agency (NOMA), or if it is subject to other formal requirements (see the sections below). ​

Does the investigation require an application or notification?

Clinical investigations that require an application 

An application to NOMA is required for clinical investigations of devices that are:

• not CE marked, or
• CE marked, but will be investigated outside of the scope of its intended purpose. 

Both investigations conducted for the purpose of future conformity assessment or CE marking as a medical device (MDR Article 62 (1)), and investigations conducted for other purposes (MDR Article 82) require an application. An application must also be submitted to the Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (REK KULMU).

Information on how to submit the application can be found on our website Clinical investigations which require an application.

Clinical investigations that require a notification 

A notification to NOMA is required for clinical investigations to further assess a CE marked device within the scope of its intended purpose, and where the investigation would 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. 

These investigations fall under MDR Article 74 (1). For guidance on what procedures are considered invasive or burdensome, please consult the Q&A regarding clinical investigations​ (MDCG 2021-6)​.

A notification must be submitted to NOMA, and an application must be submitted to the Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (REK KULMU).

Information on how to submit the notification can be found on our website Clinical investigations which require a notification.

Clinical investigations that do not require an application or notification to NOMA

Clinical investigations that fulfil the criteria below do not require an application or notification to NOMA. They do however require an application to the Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (REK KULMU):

• ​The device is CE marked and will be investigated within the scope of its intended purpose as defined by the manufacturer. 
• Subjects are not submitted to invasive or burdensome procedures which are additional to those performed under normal conditions of use. 

Clinical investigations that do not require application or notification to NOMA must fulfil the requirements specified in MDR Article 82. More information can be found on our website Other clinical investigations.

​​Regulatory guidance on clinical investigations

NOMA and the Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (REK KULMU) have jointly prepared the document "Regulatorisk veiviser for kliniske utprøvinger etter forordning (EU) 2017/745 om medisinsk utstyr (MDR)" (Regulatory guidance on clinical investigations under MDR). The purpose of the document is to guide the sponsor/project manager in questions on whether the planned study falls within the scope of MDR, and if so, whether it requires an application or notification to NOMA and/or REK KULMU. The document is only available in Norwegian. 

Regulatorisk veiviser for kliniske utprøvinger etter MDR (pdf)

Additional national requirements for clinical investigations

Additional national requirements have been introduced for clinical investigations in Norway. These requirements are described in The Regulation on medical devices § 14 and § 16.   

The national requirements state that:

• Synopses for clinical investigations must be submitted in both Norwegian and English language (§ 14).
• Clinical investigations conducted for other purposes than future conformity assessment and CE marking (cf. MDR Article 82)​ must meet all the requirements of MDR Article 62 (§ 16). However, clinical investigations of devices that are CE marked and used within their intended purpose are exempted from § 16. 

Combined studies of medical devices and medicinal products

Combined studies are studies that involve clinical trial of a medicinal product in parallel with clinical investigation of a medical device or a performance study of an IVD medical device. This can be relevant when developing products that combine medicinal products with medical devices or IVD medical devices. Please refer to our website on combined studies for more information on the requirements that apply to such studies. You can also find information on the COMBINE project (EU-project on combined studies).

Fees for applications for clinical investigations

There are no fees for applications and notifications of clinical investigations of medical devices at NOMA.