Drugdu.com expert's response:

In the process of EU CE registration, regarding the "Proof of Medical Device Equivalence," manufacturers should pay attention to the following requirements:

I. Determination of Equivalent Devices

Selection of Equivalent Devices: Manufacturers can identify one or more devices that are equivalent to the device under assessment, but each equivalent device should be equivalent to the device under assessment in all listed technical, biological, and clinical characteristics.

Proof of Equivalence: The equivalence of each equivalent device should be thoroughly investigated, described, and proven in the clinical evaluation report. Manufacturers cannot use different components of different devices to claim equivalence with the device under assessment.

Gap Analysis: Manufacturers should conduct a gap analysis to assess all clinically significant differences and determine whether the device, in terms of its safety, technical, biological, and clinical characteristics under the Medical Device Regulation (MDR), has the same or similar clinical performance as the equivalent device.

II. Clinical Evaluation and Equivalence

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

Argument for Equivalence: The consideration of equivalence should be based on appropriate scientific arguments. Manufacturers should properly investigate and document technical, biological, and clinical characteristics, fully identifying and disclosing the differences between the two devices.

Clinical Investigation: For implantable devices and Class III devices, a clinical investigation should be conducted, unless the device is designed through modifications to a device already marketed by the same manufacturer and can demonstrate its equivalence according to the MDR. For other types of devices, if manufacturers wish to claim equivalence, they should also follow the corresponding regulations and procedures.

III. Documentation and Reporting Requirements

Technical Documentation: Manufacturers need to compile and maintain technical documentation, including descriptions of the design and performance of the product, manufacturing and control processes, risk assessment and management, clinical data, etc., to prove the product's compliance with CE requirements.

Clinical Evaluation Report: The clinical evaluation report should describe in detail the determination process of equivalent devices, proof of equivalence, gap analysis, as well as the clinical data collected and analyzed.

Declaration of Conformity: Manufacturers need to draft a declaration of conformity and describe the product's conformity, including proof of equivalence with equivalent devices.

IV. Other Considerations

Selection of Certification Body: When selecting a certification body, manufacturers should ensure that it has the qualifications and capabilities to conduct medical device equivalence assessments.

Regulatory Updates and Compliance: Manufacturers should closely monitor updates and changes to EU medical device regulations to ensure that their proof of equivalence complies with the latest regulatory requirements.

Communication and Collaboration: Maintain good communication and collaboration with certification bodies and regulatory authorities to promptly resolve issues and challenges encountered during the process of proving equivalence.

In summary, the requirements for proof of medical device equivalence in the process of EU CE registration are multifaceted, including the determination of equivalent devices, clinical evaluation and equivalence, documentation and reporting requirements, and other considerations. Manufacturers should operate strictly according to these requirements to ensure that their proof of equivalence complies with EU regulations.