Clinical Trials of Medical Devices and GCP

About the Course

This course provides an overview of clinical trials for medical devices. You will gain practical knowledge about regulations, Good Clinical Practice (GCP) according to ISO 14155, and the steps involved in conducting clinical trials—from planning to documentation and approvals. The course also offers insights into the Swedish Medical Products Agency’s expectations during inspections. The course is given in Swedish (Kliniska prövningar av medicintekniska produkter och GCP).

Who Should Attend

The course is designed for those who are working in or about to start working with clinical trials for medical devices and who need documented competence in GCP for medical devices.

You may work in industry, healthcare, or academia. For instance, you could be part of a study team conducting clinical trials or hold a position at a company developing a new medical device. No prior knowledge of clinical trials is required.

Learning Objectives

The course provides an overview of clinical trials for medical devices. You’ll gain a clear picture of the practical steps involved in a clinical trial and learn about the relevant regulations, including Good Clinical Practice (GCP). You will also understand when clinical trials are required in the development phase of a medical device and learn how a clinical trial is conducted, including necessary documentation and approval requirements.

The course also offers insights into the Swedish Medical Products Agency’s expectations during clinical trial inspections. Please note that this course does not cover clinical trials for in vitro diagnostic medical devices.

Background

Clinical trials are systematic investigations conducted on humans to assess whether a medical device performs as intended and is safe to use. To market a product in the European market, results from clinical trials may be required.

Clinical trials are conducted according to Good Clinical Practice (GCP), which for medical devices is described in the ISO 14155 standard. This standard specifies that individuals working with clinical trials must have documented knowledge in GCP.

Course Content

• The Declaration of Helsinki
• ISO 14155:2020
• Medical Device Regulation (MDR) and other relevant legislation
• How clinical evaluation and Post-Market Clinical Follow-up relate to clinical trials
• Planning and conducting a clinical trial
• Documentation
• Applications/notifications
• Inspections
• Practical advice