A typical path to MDD compliance was claiming medical device equivalency, which spared businesses the time and expense of producing fresh clinical data. But since the EU MDR came into effect, the rules have altered, making equivalency a more difficult choice than it formerly was.
Methods for Establishing Medical Device Equivalency – EU MDR
How to sufficiently demonstrate equivalency between the device under examination and a similar, presently marketed item is a crucial issue for the medical device business, and it was brought up in recent changes to the European Union Medical Device Regulations (MDR).
The U.S. Food and Drug Administration (FDA) seeks to ascertain if the medical device under review is substantially identical to a legally marketed (predicate) product when a Premarket Notification (510k) is filed with the agency. According to this significant equivalency determination, the new device is at least as safe and effective as the predicate equipment. Following clearance for lawful marketing, the new device is subject to the same regulatory standards and classification as the predicate device. The public is being informed that the FDA has no worries about the new device’s efficacy or safety.
Medical Device CE Marking Procedure – EU MDR
A comparable but stricter method of proving medical device equivalency has recently been included in the CE Marking procedure for medical devices. As you may be aware, the regulatory submission required for a medical device to receive the CE Mark consists solely of technical documents about the item being evaluated; no comparison to any CE Marked device currently on the market is required. It is assessed separately from other submissions. Nonetheless, one condition of the regulatory submission—the clinical data requirement—may be satisfied (optionally) by demonstrating equivalency to a medical device bearing a current CE Mark. In contrast to the FDA’s requirements for supporting a finding of substantial equivalency, the Revision 4 update to MEDDEV 2.7/1 adds more stringent and exact requirements for a demonstration of equivalency.
The clinical, technological, and biological aspects of the device under examination and the suggested comparable device are compared, and the variations between the FDA’s and the European Commission’s evaluation methods are summarized in the tables below.
Comparing Demonstration of Equivalence with Substantial Equivalence
Finding sufficient regulatory resources to develop this comprehensive list of medical device characteristics—for both the device under consideration and the proposed comparable device—became a hurdle for many firms. It will take a significant time and specialized knowledge investment to provide sufficient proof of medical device equivalency that satisfies regulatory standards and clears the FDA or your notified body evaluation.
Comparing Medical Device Equivalency – Requirements
| Clinical content | Technical Content | Biological Content | |
| U.S. FDA 510k Application Substantial Equivalence | · A cumulative conclusion may be reached by utilising several comparable devices. · Same intended use · Risk-based comparison of anatomical site or patient population indications for use. | · Variations in the features of technology are acceptable · Disparities in technological features cannot give rise to distinct safety and efficacy concerns that materially jeopardise the safety or efficacy of the device being assessed. | • Variations in ingredients or materials are allowed • Variations in how human tissues or bodily fluids come into contact are acceptable • Similar performance testing for biocompatibility is necessary. • Variations in materials, chemicals, and contact profiles are assessed based on potential effects on two established safety or efficacy factors. |
| European Union CE Mark Technical File Demonstration of Equivalence | • It is possible to reach a cumulative conclusion by utilising multiple comparable equipment. • Same intended purpose;only one devices may be used to establish equivalency.• Similar patient group; • Same clinical state; • Same body place; • Performances not appreciably different. | Similar characteristics and attributes, same design, identical usage circumstances, comparable deployment strategies, comparable operational tenets, and comparable important performance criteria | • The same components or materials · The same bodily fluid or tissue touch. |
Medical Device Equivalence Comparisons – Content
| Clinical content | Technical Content | Biological Content | |
| U.S. FDA 510k Application Substantial Equivalence | • Classification according to regulations; • Usage indications; • Usage environment; • Patient population | • Comparative drawings or photos at the system level; Operating principles; Descriptions of technology, design, and features; Identification of important design specifications. • Performance attributes that are comparable; • Complying with standards; • Working with other devices; • Operating instructions or manuals, if they’re provided • Descriptive information on its own might be sufficient. | Results of biocompatibility testing and standard compliance; Biocompatibility evaluation and profile; products data for potentially patient-contacting products; Materials data for patient-contacting materials; |
| European Union CE Mark Technical File Demonstration of Equivalence | • Anatomical body place; • Clinical status, including illness severity and stage; • Medical indication; and intended purpose. The user population comprises of factors such as age, gender, anatomy, and physiology; clinical performances include expected clinical effect, intended purpose, and duration of use; clinical literature and concise summaries of literature including methods, results, and conclusions; assessment of the clinical literature’s methodological quality and scientific validity; the state of the art and current knowledge; the kind of device-body interaction; a description of relevant biological, clinical, and technical features that influence the device’s clinical qualities; any variations in the intended purpose, including the number of reapplications, duration of use, target patient groups, precautions, modes of application, contraindications, and target users, mode of application, duration of use, and number of reapplications.• Does the comparison encompass all products, models, sizes, settings, accessories, and the full intended use of the equipment being assessed, or just specific features? • Device equivalency conclusions, including compliance with all pertinent essential requirements • Justifications for variations in devices • If equivalency is determined, proof that the variations shouldn’t have an impact on the clinical efficacy and safety of the device being evaluated; an explanation of any shortcomings and gaps • Finding discrepancies, assessing expected effects on clinical performance and safety, and providing justification for assumptions; • Determining the applicability of every dataset derived from a comparable device • The extent of clinical and technical data availability from the suggested analogous device. |
• Models, names, sizes, configurations, and parts • Connection to the device being evaluated; • Validity and justification of parameters and models for non-clinical characteristic determination • Operating principles and how the device accomplishes the therapeutic outcome; • Specifications and properties (energy type and intensity, tensile strength, viscosity, surface characteristics, wavelength, surface texture, porosity, particle size, nanotechnology, specific mass, atomic inclusions, etc.); • Corrective measures for field safety; • Product labels and usage instructions • If measurements are possible, supporting non-clinical information and testing of clinically relevant specifications and properties evaluated both devices, given in a comparison approach; | • Information about the nature, function, and risk assessment of materials and chemicals that come into contact with the body • Body contact type; • Information on biological safety tests (e.g., ISO 10993) • Production data for unique treatments; • Procurement and production processes; • Selective analytical techniques for material description Histopathological investigations on the host response in vivo in the intended application and duration of contact • Species identification and rationale for test selection and predictive value in animal experiments • Host reaction to particles and abrasion, if applicable; • Any variation in biological features should be supported by an explanation of the circumstances. |
Tip 1: Recognize the procedure – A thorough examination of medical device equivalency and its significance for MDR device approval The process of proving that two or more devices are equivalent to the extent that there is no clinically significant difference in their clinical performance and safety is known as equivalency. Put otherwise, it goes much beyond just demonstrating that two things are “similar”; equivalent refers to anything that is “essentially the same as,” which is more difficult to establish than a similarity claim. Only if the subject product is demonstrated to be clinically, technically, and biologically identical to another CE-marked device already on the market will an equivalency claim be valid.
Tip 2: Prepare beforehand – Three elements are included in a claim of equivalency: the device’s technical, biological, and clinical characteristics. Therefore, it won’t pass muster if you are comparing two gadgets that are identical in terms of features but are constructed of different materials. Consequently, before making a claim, take some time to thoroughly examine the characteristics of the topic and comparable technology in each of the three categories.
MedDev 2.7/1 rev 4 states that equivalency claims must be supported by substantial scientific data. In order to address the device’s technical, biological, and clinical characteristics, a thorough literature search might be necessary.
Tip 3: Obtain enough access – It is required under the MDR to demonstrate that you have adequate access to the data pertaining to the similar device. This criterion goes all the way up to establishing a contract with the maker of the comparable equipment that permits complete access to technical files for class III devices. This virtually eliminates the possibility of equivalency for many Class III devices because the comparable product is frequently manufactured by a rival.
Although the term “sufficient access” isn’t precisely defined for other device types, there are a few guidelines to follow. It’s important to clarify certain points in the sufficient access statement. For instance, if it’s clear from publicly accessible data that two devices are functionally equivalent, specify that the “key data” that needs to be accessed pertains to biological and clinical features. This aids in focusing the reviewer’s attention.
In addition, this might make it possible to do tests or get hands-on experience with the gadget in order to pass the sufficiency exam. Meeting the access test ultimately requires judgement, although it’s not always necessary to steal technical documents from rival companies. Apart from Class III devices, the focus is on developing a logical case and gathering as much data as you can.
Tip 4: Transform into three dimensions – The devices’ technical, biological, and clinical features are the three aspects that must be taken into account when proving equivalency. Now that the preparation is complete, it’s time to formulate the claim. The lowdown on every facet of equivalency is as follows:
- Technical: Technical equivalency refers to the device’s similar design, usage under comparable circumstances, characteristics, including physicochemical properties, and deployment methods (where appropriate). It also refers to the device’s operating principles and critical performance requirements.
- Biological: The apparatus utilises identical materials or compounds in contact with identical human tissues or bodily fluids for comparable types and lengths of contact, together with comparable properties of substance release, like leachables and degradation products.
- Clinical: Clinical equivalency can only be asserted in cases where the device is utilised for a similar clinical condition, such as a disease with a similar severity and stage, at the same site in the body, in a population with similar age, anatomy, and physiology, with the same type of user, and with a comparable relevant critical performance taking the expected clinical effect for a specific intended purpose into consideration.
Tip 5: Communicate your message
Don’t allow your claim be rejected after all this work because it isn’t presented in a way that the reviewer finds compelling. The best way to present the data analysis and comparison is to create a series of tables that compare the clinical, biological, and technological characteristics of the devices and include a column that details how any discrepancies may affect clinical safety and performance. With this forensic, line-by-line method, the reviewer may track the development of the argument. A paragraph after the tables should properly justify any discrepancies found and how they affect performance and safety.
Conclusion – Navigating the path to Medical Device Directive (MDD) compliance has undergone significant changes with the implementation of the European Union Medical Device Regulations (MDR). Prior reliance on claiming medical device equivalency has become more challenging under the new regulations. Both the U.S. Food and Drug Administration (FDA) and the European Union (EU) CE Marking procedure require a thorough demonstration of equivalency, but there are notable differences in their approaches. To successfully establish equivalency, thorough preparation is essential, involving a detailed examination of the device’s technical, biological, and clinical characteristics. Access to relevant data, especially for class III devices, is crucial, and presenting the claim in a clear and compelling manner through tables and justifications can enhance its credibility. Ultimately, achieving medical device equivalency requires a meticulous approach, supported by substantial scientific data and adherence to regulatory standards. While the process may be complex and time-consuming, it is essential for ensuring the safety and efficacy of medical devices in the market.
