The MDR (Annex XIV, Part A) emphasizes the importance of considering technical, biological, and clinical characteristics when demonstrating equivalence to other devices.
The demonstration of equivalence must adhere to the requirements outlined in Part A, section 3 of Annex XIV of EU MDR.
Annex XIV part A requires that the manufacturer should demonstrate that there are no clinically significant differences in safety or clinical performance with regard to technical, biological and clinical characteristics.
MEDDEV 2.7/1 Rev. 4 is a guidance document that provides guidance on clinical evaluation in the European Union. However, because it was published before MDR, it comes with some differences in this guidance and the regulations that has led to some confusion with respect to demonstrating equivalence.
MDCG 2020–5 explains these differences and also clarifies the prerequisites for determining equivalence in the EU. The document ends with some guidance on the identifying and utilizing clinical data.
Parameters For Demonstration Of Equivalence Clinical Aspects In The EU
According to MDR and MEDDEV 2.7/1, manufacturers have to regard three characteristics while justifying device equivalency to their products: Technical, Biological and Clinical.
MDCG 2020–5 compares MEDDEV 2.7/1 Rev. 4 and MDR criteria for characteristics, explaining any significant differences and their significance for EU equivalence demonstration.
Technical:
As per MDR, Annex XIV Part A (3), it requires that technical characteristics shall be taken into consideration for the demonstration of equivalence, including that the device in question and the device presumed to be equivalent, the device should share similar design, usage conditions, physicochemical properties, deployment methods, principles of
operation, and critical performance requirements, with similar physicochemical properties, deployment methods, and critical performance requirements, including viscosity, energy intensity, surface characteristics, tensile strength, and software algorithms.
As per MEDDEV 2.7/1 Rev. 4, Appendix A1 requires that technical characteristics shall be taken into consideration for the demonstration of equivalence, including that the device in question and the device presumed to be equivalent are the device be of similar design, used under the same conditions of use, and have similar specifications and properties
(e.g., physicochemical properties similar to type and intensity of energy, viscosity, tensile strength, surface characteristics, wavelength, porosity, particle size, surface texture, specific mass, nanotechnology, atomic inclusions similar as nitrocarburising, oxidability), and use similar deployment methods (if relevant), and have analogous principles of operation and critical performance requirements Software equivalence.
In the section on technical characteristics, MDCG 2020–5 emphasizes that software equivalence is based on the functional principle of a software algorithm, clinical performance, and intended purpose, and it is not reasonable to demand equivalence for the software code
Similar vs. same technical characteristics of devices dictate that they should be used under similar conditions, while MEDDEV 2.7/1 Rev. 4 states they should be used under the same conditions. MDCG 2020–5 clarifies that similar conditions are only applicable if there is no clinically significant difference in safety and performance between the devices.
Biological:
As per MDR, Annex XIV Part A (3), it requires that biological characteristics shall be taken into consideration for the demonstration of equivalence; that is, the device uses the same materials or substances in contact with the same human tissues or body fluids for similar contact duration and release characteristics, including degradation products and leachable.
As per MEDDEV 2.7/1 Rev. 4, Appendix A1 requires the device should use the same materials or substances in contact with the same human tissues or the same type of body fluids.
Exceptions can be previsioned for devices that come in contact with intact skin and minor components of devices; in these cases, risk analysis results may allow the use of similar materials, taking into account the role and nature of the similar material.
Biological characteristic exceptions. MEDDEV 2.7/1 Revision creates exceptions for reviewing biological qualities using “similar” materials. MDCG 2020–5 clearly states that these exceptions to not using the same materials “are NOT acceptable under the MDR.”
~ The MDR makes a clear distinction between “same” and “similar” when defining these criteria, with “similar” denoting something that is similar but not identical and “same” denoting something that is identical.
A scientific rationale should support equivalency for each of these criteria, demonstrating that there are no clinically meaningful differences in the devices’ performance and safety for the target patient group.
~ If your device includes a difference with the equivalent device, or a modification (which could have been introduced to address a safety or performance issue of the equivalent device), a strong scientific justification should be provided to demonstrate that there is no impact on the clinical safety or performance of the device. Use the same materials “are NOT acceptable under the MDR.”
Clinical:
As per MDR,Annex XIV Part A (3) requires that both the medical device to be evaluated and the equivalent product must be used for the same clinical condition or purpose, including similar disease severity and stage.
It should be at the same site in the body, in a similar population, including in terms of age, anatomy, and physiology.
It has the same kind of user, and it has to perform similarly in terms of relevant critical performance in light of the anticipated clinical effect for a particular intended purpose, according to MDR, Annex 14.
As per MEDDEV 2.7/1 Rev. 4, Appendix A1 requires that the medical device is to be evaluated, and the equivalent product must be used for the same clinical condition (including, when applicable, similar severity and stage of disease and the same medical indication), and both devices are to be used for the same intended purpose, at the same site in the body, and in a similar population
(this may relate to age, gender, anatomy, physiology, and possibly other aspects). It is not previsioned to deliver significantly different performances (in the relevant critical performances, such as the expected clinical effect, the specific intended purpose, the duration of use, etc.).
The MDR does not specify that the device must be used for the same medical indication, gender, or duration, but MDCG 2020–5 outlines that both devices must be used for the same clinical condition or purpose.
CONCLUSION
The Medical Device Regulation (MDR) mandates manufacturers to demonstrate equivalence in relation to other devices based on technical, biological and clinical characteristics. MDCG 2020–5 clarifies these differences and outlines prerequisites for determining equivalence in the EU.
Technical characteristics include similar design, use under similar conditions, specifications, and critical performance requirements. Biological characteristics involve using the same materials or substances in contact with human tissues or body fluids, with exceptions for devices in contact with intact skin.
The device must be used for the same clinical condition or purpose, with similar severity and stage of disease, at the same site in the body, in a similar population, with the same user, and have similar critical performance for the expected clinical effect. MDCG 2020–5 covers these requirements, ensuring both devices must be used for the same clinical condition or purpose.
AUTHOR: Dr. Minu Lazar, BDS (Junior Consultant CER)
REFERENCE
- 1. MEDDEV 2.7/7 revision 4, clinical evaluation: a guide for manufactures and notified bodies under directives 93/42/EEC and 90/385/EE
- 2. MDCG 2020–5 Clinical Evaluation — Equivalence
- 3. EU MDR
- 4. Laura Court, MDCG 2020–5 Explained: How To Demonstrate Equivalency in the EU (2022)
- 5. Helen Quie, How to use the Equivalence Pathway under MDR
