Clinical Evaluation of Medical Devices

The main regulatory framework for the medical device clinical evaluation is provided in Article 61 and Annex XIV of the Medical Device Regulation (EU) 2017/745 (MDR).  There are also other sources that may provide additional support for clinical evaluation of your medical device, but their applicability should be considered in each specific case:

• MDCG 2020-5 Guidance on clinical evaluation – Equivalence
• MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices
• MDCG 2024-10 Clinical evaluation of orphan medical devices
• MEDDEV 2.7/1 rev.4 Clinical evaluation: Guide for manufacturers and notified bodies
• MDCG 2020-13 Clinical evaluation assessment report template

These terms are related but distinct. The exact definitions are provided in Article 2 of the MDR. Performance refers to the device's ability to achieve its intended purpose. Clinical performance adds the aspect of how well the device performs in actual clinical use.  Clinical benefit is the positive impact the device has on patient health outcomes. These characteristics of medical devices are crucial for the whole device development and, for clinical evaluation in particular, they should be clearly defined at the beginning of the device development and should remain unchanged.

This is one of the most important questions that manufacturers may face during device development. The level of data required depends on the classification of the device (Class I, IIa, IIb, III) according to the MDR. Higher risk devices require a more robust clinical strategy, potentially including clinical investigations. The level of clinical data as well as how this data is collected should be defined individually in each specific case.

The MDR provides strict rules on equivalency. Equivalence should be demonstrated thoroughly in terms of technical, biological, and clinical equivalence between the devices. For implantable devices and class III devices there are two additional requirements: manufacturers should have a contract allowing full ongoing access to the technical documentation of the device to which equivalence is claimed, and the clinical evaluation of the equivalent device should be conducted according to the MDR.

Claiming equivalence may be challenging and requires a comprehensive approach.

The sources of clinical data are determined based on the definition of clinical data provided in Article 2 of the MDR:

• Clinical investigation(s) of the device under evaluation,
• Clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated,
• Reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated,
• Clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up.