Introduction to clinical investigations of medical devices
Here you can find information on the notification duty, when clinical investigations of medical devices are required, and the considerations to be made before you apply for authorisation for a clinical investigation.
In Denmark, the person with the overall responsibility for a clinical investigation of a medical device must notify the Danish Medicines Agency of the investigation. The notification duty applies to all clinical investigations of non CE marked medical devices and CE marked devices, if the objective of the investigation is to use the medical device for a new purpose.
Before starting your investigation, you must obtain authorisation from the regional research ethics committee and the Danish Medicines Agency.
Investigations of CE marked medical devices used for the intended purpose do not have to be approved by the Danish Medicines Agency/Medical Devices. However, if the clinical investigation includes testing of medicinal products, the investigation may be covered by the notification duty for clinical trials. For more information on the notification duty, see guidelines on clinical trials of medicines in humans.
Danish Medicines Agency/Medical Devices: email@example.com
Danish Medicines Agency/Clinical Trials (medicines): firstname.lastname@example.org
All clinical investigations of medical devices – CE marked and non CE marked - must be notified to a research ethics committee, which primarily assesses the ethical aspects of the investigation.
Practical considerations before starting a clinical investigation
When considering whether a clinical investigation of a medical device is required, you should assess which type of data is necessary to demonstrate compliance with the essential requirements of the relevant executive order, the purpose of the device and the risk assessment. You should consider the following:
- Which of the essential requirements in the executive orders apply to the relevant product
- Which data are necessary to demonstrate compliance with the relevant essential requirements
- Which investigations are required to provide these data, e.g. in vitro tests, animal studies
- Are clinical data required to demonstrate compliance with the relevant essential requirements? If so, are clinical data for the relevant device available or have any generated clinical data been published concerning equivalent devices that are relevant to the product.
A clinical investigation of a device should be considered carefully in the following cases:
- Introduction of an entirely new concept within devices for clinical use where components, properties and/or mode of action are unknown
- Modification of an existing device so that it contains new properties, especially if these properties have an important physiological effect, or if the modification can have a significant impact on the clinical performance and/or safety of the device.
- If the device contains materials not previously tested in human subjects, if these materials come in contact with the human body, or if known materials are used on new areas of the body
- If a device - CE marked or non CE marked - is intended for a new purpose or function
- If in vitro tests and/or animal studies cannot imitate the clinical situation
- If it is a new manufacturer of high-risk devices.
If the manufacturer is uncertain whether sufficient clinical data is available to demonstrate compliance with the essential requirements for CE marking of the device, it may be useful to discuss the need for a clinical investigation with the notified body.