Drugdu.com expert's response:

Under the framework of the EU Medical Device Regulation (MDR), the demonstration of equivalence for medical devices is a crucial step in assessing the similarity between a new product and a marketed product in terms of technical, biological, and clinical characteristics. This directly determines whether the new product can enter the EU market in compliance with regulations. Below are the key provisions and requirements that need to be mastered for demonstrating equivalence:

I. Technical Characteristics Requirements

Similar Usage Conditions: The device under evaluation and the presumed equivalent device must be used under similar conditions, meaning there should be no significant clinical differences in their safety and clinical performance. This implies that in real-world medical scenarios, both devices should exhibit similar levels of patient protection and stability in treatment outcomes.

Similar Software Algorithms: For medical devices incorporating software algorithms, the functional principles, clinical performance, and intended purposes of their software algorithms must be similar to those of the presumed equivalent device. This encompasses software algorithms that drive or influence the use of the device, as well as those intended for standalone use.

II. Biological Characteristics Requirements

Identical Materials or Substances: The device under evaluation must use the same materials or substances as the presumed equivalent device for contact with human tissues or body fluids, with similar types and durations of contact.

Similar Substance Release Characteristics: Both devices should exhibit similar substance release characteristics, including degradation products and leachables. This is because even with identical raw materials, minor variations in processing techniques, design, or usage environment can lead to differences in substance release, thereby affecting the biocompatibility of the device.

Compliance with ISO 10993 Series Standards: When demonstrating equivalence, the principles of biological evaluation for medical devices outlined in the ISO 10993 series standards should be followed. These principles encompass a comprehensive range of considerations, from cytotoxicity tests to long-term risk assessments such as genotoxicity and carcinogenicity, to ensure the biological safety of the device.

III. Clinical Characteristics Requirements

Same User Types: The device under evaluation must have the same types of users as the presumed equivalent device. This includes all healthcare personnel or non-personnel who use the device. When considering equivalence, manufacturers must take into account whether the capabilities or knowledge of the intended users could impact safety, clinical performance, and outcomes.

Same Clinical Conditions or Purposes: The device under evaluation must be used for the same clinical conditions or purposes as the presumed equivalent device. This equates to the same medical conditions, genders, and usage durations, while also considering similar severities and disease stages, as well as having similar key performance characteristics. This means that the device should perform consistently across different medical institutions, patient populations, or disease stages.

IV. Other Requirements

Contractual Requirements: For medical devices containing auxiliary drugs (Class III devices), if the manufacturer intends to claim equivalence with devices produced by other manufacturers, the MDR requires that both manufacturers sign a contract explicitly allowing the manufacturer to have continuous and comprehensive access to the technical documentation.

Gap Analysis: Manufacturers should conduct a gap analysis to assess all clinically significant differences and determine the degree of clinically significant differences in terms of safety, technical, biological, and clinical characteristics under the MDR, and whether they are the same as or similar to the clinical performance of the equivalent device.

Clinical Evidence Level: Manufacturers should specify and demonstrate the necessary level of clinical evidence to prove compliance with relevant general safety and performance requirements. The level of clinical evidence should be appropriate and matched to the characteristics of the device and its intended use.

Equivalence Demonstration: Considerations of equivalence should be based on appropriate scientific justification. Manufacturers should properly investigate and document the technical, biological, and clinical characteristics, fully identifying and disclosing differences between the two devices.