Equivalence of medical devices under MDR

05.06.2024

Metecon GmbH is a strategic manufacturer of medical devices and IVDs. The company offers comprehensive advice and support for market access and post-market surveillance.

Compliance with the regulations on equivalence of medical devices in accordance with the Medical Device Regulation (MDR) presents companies with considerable hurdles. The importance of adequately demonstrating equivalence becomes particularly clear during clinical evaluation. As correct proof not only contributes to conformity, but also saves time and money.

The process for demonstrating conformity in accordance with the MDR is explained in detail in a new guide. This provides a comprehensive overview of the requirements, processes and implications of the sameness guidance. Demonstrating equivalence is important as many medical devices require clinical data to confirm their compliance with the safety and performance requirements of the MDR. However, clinical investigation can be time consuming and costly, so this data is generated from the use of the device.  

How is similarity demonstrated?  

In particular for implementable and Class III products, access to technical documentation is a challenge. While an exchange of information between competitors is rare, there is an exception if similarity with a product from the same manufacturer can be proven. It should be noted that proof of similarity requires that certain features are actually "the same", while for others only similarities are required. Scientific justification must be provided as to whether differences have a significant impact on clinical performance or safety.  

What is not possible?  

Equivalence cannot be demonstrated between devices with different intended purposes. The use of clinical data from similar medical devices without proof of equivalence also leads to problems.  

What are the next steps?  

Similar or similar devices whose clinical data was used for the conformity assessment must continue to be monitored as part of post-market clinical follow-up measures. This is intended to ensure a continuous update of the benefit-risk ratio.