EU MDR insists on clinical data to prove the safety and performance of the device under assessment. Whilst carrying out a clinical investigation is the most direct way to generate clinical data concerning the safety and performance of devices for the purpose of CE marking. But EU MDR provides a possibility to use clinical data sourced from data of a device for which the equivalence to the device in question can be demonstrated. This data can be sourced from either:
- clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated
- reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated
To be able to use this data, the equivalence needs to be established beyond doubt by considering the clinical, technical and biological characteristics. Let’s look at what these mean in detail.
- Clinical characteristics: The device is intended for the same clinical condition or purpose, addressing a similar severity and stage of disease, and is used at the same anatomical site in a comparable patient population, considering factors such as age, anatomy, and physiology. It is operated by the same type of user and demonstrates similar critical performance relevant to the expected clinical outcomes for its intended use.
- Technical characteristics: The device shares a similar design and is intended for use under comparable conditions. It exhibits similar specifications and characteristics, including physicochemical properties such as energy intensity, tensile strength, viscosity, surface features, wavelength, and software algorithms. Where applicable, it employs similar deployment methods and operates on comparable principles, meeting equivalent critical performance requirements.
- Biological characteristics: The device is made of the same materials or substances that come into contact with the same human tissues or body fluids, for a similar type and duration of contact. It also has similar release properties, including those related to degradation products and leachables.
These characteristics must be sufficiently similar to ensure there is no clinically meaningful difference in the device’s safety or clinical performance. Any claim of equivalence must be supported by sound scientific justification.
Note: If equivalence is being claimed for an implantable or Class III device with a device from another manufacturer, it is essential to have a current and legally binding agreement in place. This agreement must ensure ongoing access to the necessary technical documentation, in compliance with Article 61(5) of the MDR.
How can RNCS help?
- Evaluate whether equivalence is a viable route for your device.
- Identifying possible equivalent devices
- Determine if sufficient clinical, technical, and biological similarities exist and demonstrating equivalence
- Once equivalence is demonstrated- searching and extracting data from peer-reviewed literature, clinical study databases, or manufacturer documentation to include in clinical evaluation
- Advise whether a clinical investigation is more appropriate based on gaps
Demonstrating equivalence under the EU MDR is a complex and highly scrutinized process that requires clear, evidence-based justification across clinical, technical, and biological parameters. Unlike the previous MDD, the MDR sets a higher bar for proving equivalence, particularly when relying on data from third-party devices. Manufacturers must ensure that any claims of similarity are supported by detailed comparisons and, where necessary, formal access to the technical documentation of the equivalent device. When approached systematically and supported by robust scientific evidence, the equivalence pathway can be a valuable tool to meet regulatory requirements while optimizing development timelines and minimizing the need for new clinical investigations.
For more details, Contact RN Consulting Solutions MedTech Compliance Experts
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