Clinical Investigation Plans and Reports for clinical trials

Is a clinical investigation required?

According to the European Medical Device Regulation (MDR; Article 61), clinical data is needed to demonstrate the safety and performance of a medical device. The clinical data may be derived from various sources (e.g., literature, post market surveillance, clinical investigations, etc.). Clinical investigations are, however, required for implantable devices, class III devices and products without an intended medical purpose (MDR article 61, sections 4, 5, 6 and 9) unless certain exceptions apply.

Similarly, the European in-vitro diagnostic regulation (IVDR; Article 56) requires that clinical performance studies are carried out for in vitro diagnostic medical devices unless it can be duly justified to rely on other sources of clinical performance data.

Through AML Christensen’s consulting service, we can help you determine whether there is a need for a clinical investigation or clinical performance study for your device. When a clinical investigation is not needed, we can write a justification to be inserted in the Clinical Evaluation Report (CER) / Performance Evaluation Report (PER).

Clinical Investigation documents

When there is a need for a clinical investigation, AML Christensen can help you design a study that complies with the requirements of the MDR/IVDR, ISO 14155, ISO 14971 and Good Clinical Practice. The objectives and design of your clinical investigation will be formulated in a Clinical Investigation Plan, and the results will be described in a Clinical Investigation Report. Moreover, an Investigator’s Brochure will be created to summarize existing clinical data and preclinical tests for your device, and a Case Report Form will be used to provide information on the condition of the study participants.

Reach out

Clinical Investigation Plans and Reports for clinical trials

Is a clinical investigation required?

Clinical Investigation documents

Address:

Contact:

Reach out