Understanding MDCG 2020-5 for Medical Device Equivalence

Demonstration of equivalence is an important part of performing clinical evaluation of the device in scope. Equivalence refers to demonstrating that a new medical device is safe and effective as an existing device with specific characteristics. Demonstrating equivalence enables manufacturers to utilize existing data and insights on equivalent devices, facilitating the approval or clearance of their own device. This streamlines regulatory procedures and minimizes the requirement for extensive clinical testing. In addition to ensuring patient safety, It can save time and resources, accelerate market entry, and provide a pathway for innovation.

MDR Requirements

• Annex XIV part A says that manufacturers have to show that their product is just as safe and effective as the original in terms of its technical, biological, and clinical features. They need to compare these features to see if they’re the same or similar as defined in the standard.
• In Article 2 of the MDR point no. 48, the definition of clinical data allows for using information from an equivalent device.
• Article 61 (4) allows for Class III and Implantable devices claiming equivalence to be exempt from premarket clinical investigations and directs the reader to Annex XIV Section 3 for more clarity.

What is the equivalence?

Clinical equivalence refers to the demonstration that a new medical device is as safe and effective as an already established device (a reference device) in terms of intended use, design, principles of operation, and clinical performance. According to the MEDDEV 2.7/1 Rev.4, which is stated similarly to the MDR, when creating a clinical evaluation based on the equivalency principle, technical, biological, and clinical aspects must be taken into account in the assessment of equivalency. The criteria for assessing these three characteristics—which are addressed in the MDCG 2020-5 document—show differences between MDR and MEDDEV 2.7/1 Rev. 4.

Technical characteristic

While MEDDEV 2.7/1 Rev. 4 states that the medical device being evaluated and its equivalent must be used under the same conditions, the MDR only requires similar conditions of use. If there’s no expected significant difference in safety and performance, the conditions of use are considered similar.

According to MDCG 2020-5, the MDR specifically focuses on software algorithms, unlike MEDDEV 2.7/1 Rev. 4. This includes software necessary for a medical device’s operation and software classified as a medical device itself. To demonstrate equivalence under the MDR, both the software’s functional principle (or underlying algorithm) and its clinical performance and intended purpose must be considered.

Technical Equivalence

• Similar Design
• Similar condition of use
• Similar specifications and properties
• Similar deployment method
• Similar principle of operation and critical performance

Biological characteristic

The Previous MEDDEV 2.7/1 Rev. 4 and MDR both require the same “use of the same materials or substances in contact with the same type of human tissue or body fluids” of a medical device in scope.

According to the MEDDEV 2.7/1 Rev. 4 exceptions can be accepted for devices in contact with intact skin and minor components of devices. Where the findings of the risk analysis may allow the use of similar materials taking into account the role and nature of the similar material. This is no longer permissible in the legal framework of the MDR. MDCG 2020-5 explicitly points this out.

Additionally to establish biological equivalence under the Medical Device Regulation (MDR), it is necessary to demonstrate that the substances used have a similar period of use and release mechanism, including their degradation products and leachables. MDCG 2020-5 explains that this requirement accommodates potential changes resulting from external factors or processing, even if the raw materials remain unchanged.

In cases where medical devices contain multiple substances or combinations thereof that interact with the human body through absorption or dissolution, equivalence is proven by using the same substances. Despite not being classified as medicinal products, MDCG 2020-5 highlights the importance of adhering to relevant requirements outlined in Annex 1 of Directive 2001/83/EC to assert biological equivalence under the MDR. In case of medical devices with an ancillary medicinal substance, MDR requires biological characteristics to be taken into account while demonstrating equivalency. These characteristics include the use of “the same materials or substances in contact with the same human tissues or body fluids” by both the device under evaluation and the device that is considered to be equivalent. This remains true for any accompanying excipients or coatings as they may alter the performance of the device.

Biological Equivalence

• Same material or substance
• Same human tissue/ body fluids
• Similar kind and duration
• Similar release characteristics

Clinical characteristic

MDR requires that device to be used by the same kind of intended user, whether the user is a layman who utilizes a device, whether they are a healthcare professional or not. The requirement that the medical device be used for the same medical indication, gender, and duration of use as the equivalent device is not stated clearly in the MDR. But in general, this is covered by the MDR requirement, which is also described in the MEDDEV 2.7/1 rev. 4, that both devices be used for the same clinical condition or purpose, including similarity in severity and stage of disease, as well as having similar relevant critical performance.

In assessing equivalence under the MDR, it is crucial to compare technical, biological, and clinical characteristics to ensure there are no clinically significant differences in safety and performance compared to the reference device. While some characteristics must be identical, others may be similar, necessitating a thorough gap analysis. Any modifications made to the device must be justified, ensuring they only address specific safety or performance issues without introducing additional risks. Manufacturers must avoid claiming equivalence to products that do not have an intended medical purpose as listed in Annex XVI of the MDR.

Manufacturers must ensure that each device identified as equivalent to the one under evaluation possesses identical technical, biological, and clinical characteristics. This prohibits the use of different parts from various devices to claim equivalence. However, in exceptional cases, deviations from this principle may be considered.

The MDR mandates that manufacturers define and justify the required level of clinical evidence to establish conformity with relevant safety and performance requirements. This level of evidence should be suitable considering the device’s characteristics and intended purpose. Equivalence assessments must be based on proper scientific justification.

MDCG 2020-5 outlines the limitations of the equivalence procedure, particularly for manufacturers of class III and implantable devices. Equivalence is only permissible in two specific scenarios:

• When the manufacturer references a previously CE-approved product from their own company, complying with MDR or previous directives.
• When the manufacturer references an equivalent product from a competitor with whom there’s a contractual agreement allowing access to technical documentation and clinical evaluation, certified under the MDR.

In all other cases, demonstrating safety and clinical performance requires clinical investigations.

For products without a medical purpose listed in MDR Annex XVI, clinical investigations are required unless justified by relying on existing data from a similar medical device. Equivalence principles apply, with attention to safety requirements. The product must demonstrate no significant differences in safety and performance compared to the analogous medical device. Guidance on demonstrating equivalence for such products is provided in MDCG 2023-6.

For demonstrating the equivalence, all available data for both the evaluated medical device and its equivalent should be utilized, regardless of whether the results are positive or negative concerning safety and clinical performance. The analysis of this data is focused on aligning or establishing compliance with essential safety and performance requirements. The identification and analysis of data is done as per MEDDEV 2.7/1 Rev 4.

Clinical Equivalence

• Same clinical condition
• Similar severity and stage of disease
• Same site in the body anatomical location
• Similar population
• Same user
• Similar clinical effect

Conclusion

Clinical equivalence is a cornerstone of regulatory compliance and patient safety in the medical device industry, particularly under the EU MDR framework. By demonstrating that a new device is clinically equivalent to an established reference device, manufacturers can navigate the regulatory pathway more efficiently while upholding the highest standards of safety and efficacy.