Clinical investigation of medical device

A clinical investigation is a systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.

Clinical investigations shall be performed on the basis of an appropriate investigation plan that is reflecting the latest scientific and technical knowledge. The investigation plan shall be designed to demonstrate whether the device is safe and achieves the performance intended as claimed by the manufacturer and that the benefit of the device outweighs the risks.

Good Clinical Practice

Clinical investigations of medical devices should be carried out in accordance with good clinical practice, as described in the international standard ISO 14155 Clinical investigation of medical devices – Good clinical practice.

The latest version of the standard, SS-EN ISO 14155:2020, has been adopted as European and national Swedish standard but is not yet harmonised with the medical device directives nor with the EU regulation 2017/745 on medical devices, also called MDR.

The previous version SS-EN ISO 14155:2011 is harmonized with the medical device directives.

The Swedish Medical Products Agency (Swedish MPA) recommends using the latest published version of the standard.

Authorisation

When conducting a clinical investigation one must make sure that all required authorisations are in place. If the investigation design is modified, this modification (amendment) might need to be notified to the Swedish MPA depending on type of modification, and an authorisation from the Swedish MPA is then required before the modification can be implemented.

All clinical investigations medical devices in Sweden have to be submitted to the Swedish MPA as of 15 July 2021. This applies also for those clinical investigations for which an ethics approval previously was sufficient.

• An authorisation is required if the investigational device does not carry the CE mark, or if it has been CE marked for a different intended purpose that the use planned in the clinical investigation.
• Clinical investigations of CE marked devices, where the devices are used within the scope of the intended purpose for which they have been CE marked have to be notified to the Swedish MPA at least 30 days before study start, but no authorisation from the Swedish MPA is required.
• All clinical investigations in Sweden must undergo ethical review by the Swedish Ethical Review Authority before they can be started, the procedure is however dependent on the applicable legislation. Read more about this on the page Application and notification.
• If the investigation design is modified, this modification (amendment) might need to be notified to the Swedish MPA depending on type of modification, and an authorisation from the Swedish MPA is then required before the modification can be implemented.

Sponsor

The company, individual, institution or organisation which takes responsibility for the initiation, management and setting up of the financing of the clinical investigation, is called sponsor.

Among other things, the sponsor shall:

• make sure all documentation about the investigation and investigational device is available for the competent national authorities before, during and after the investigation
• obtain all necessary authorisations
• have an agreement with the investigators in place to ensure that any serious adverse events and product deficiencies that could have caused serious adverse events, are reported by the investigators to the sponsor
• make sure the investigation is conducted according to good clinical practice
• prepare a clinical investigation report.

Investigator

An individual responsible for the conduct of a clinical investigation at a clinical investigation site is called an investigator.

More information regarding different types of investigators and requirements under Educational material. 

Subject

An individual who participates in a clinical investigation is called a subject. It is important that the subject participates voluntarily, and that the investigator has provided the subject with information about the study and the foreseen risks, before the subject consents to participation. In exceptional cases a legal representative may be designated to provide consent on behalf of the subject.

Investigational device

The devices tested in a clinical investigation must conform to the general safety and performance requirements in the medical device regulation, apart from the aspects covered by the clinical investigation.

Every precaution has been taken to protect the health and safety of the study subjects.

It is the responsibility of the manufacturer of the investigational device to have the necessary documentation on the device’s safety and performance. The manufacturer has to confirm that the device conforms to the requirements, even if the manufacturer is not the sponsor for the clinical investigation.

A sponsor who makes any changes to the device, including application of additional labels, will need to ensure that the devices still conforms to the relevant requirements.

A manufacturer or sponsor who engages a subcontractor to handle investigational supplies should by contract and other appropriate means ensure that the subcontractor complies with quality requirements defined by the manufacturer or sponsor.

Template for declaration of conformity

Notification during the ongoing investigation

Serious adverse events, substantial modifications and other updates made during the investigation must be reported or notified to the Swedish MPA. When the clinical investigation is completed or temporary halted, the Swedish MPA must be notified.

Control of clinical investigations

The Swedish MPA performs surveillance of clinical investigations of medical devices in Sweden. This means that we review that the clinical investigations are conducted according to applicable laws and regulations. As part of the MPA surveillance activities, GCP inspections may be performed, mainly at participating investigation sites. Surveillance may also be performed as in-depth review of the clinical investigation documentation.

If the Swedish MPA considers that the regulatory requirements are not fulfilled, the Swedish MPA may interfere and require that the sponsor amends the investigation. The Swedish MPA may also recall the authorisation for a clinical investigation, require that the investigation is temporary halted or stopped permanently.