Claiming Equivalence FAQ
Q: What is the difference between claiming equivalence under EU MDR compared to MDD?
A: Claiming equivalence under the EU MDR can streamline the certification process for medical devices, saving time and costs for manufacturers. However, the MDR places increased emphasis on ensuring the safety and efficacy of medical devices, especially in light of past incidents involving devices like breast implants and hip replacements. Therefore, manufacturers must exercise caution and adhere to stringent requirements when pursuing equivalence submissions, as skipping clinical studies can remove a crucial safety reassurance from the registration process.
Q: What are the key requirements for demonstrating equivalence under the EU MDR?
A: Manufacturers must demonstrate sufficient levels of access to data and include robust clinical data in their Clinical Evaluation to claim equivalence under the MDR. Equivalence must be established based on technical, biological, and clinical parameters, ensuring that the device under evaluation is similar to a previously marketed device in terms of design, materials, clinical condition, and intended use.
Q: What is the difference for demonstrating equivalence between EU MDR and MEDDEV 2.7/1 Rev 4 guidelines?
A: The MDR imposes stricter requirements for demonstrating equivalence compared to the MEDDEV 2.7/1 Rev 4 guidelines. Under the MDR, manufacturers must provide comprehensive technical, biological, and clinical documentation to support their equivalence claims. This includes proving similarities in design, materials, clinical conditions, and intended use between the devices. The MDR emphasizes that equivalence claims must be supported by scientific justification, and any differences between the devices must not result in clinically significant variations in safety and performance.
Q: How do manufacturers demonstrate equivalence for class III and implantable devices under the MDR?
A: For class III and implantable devices, manufacturers may avoid clinical investigations under specific conditions outlined in Article 61(4) of the MDR. This includes demonstrating equivalence between the device under evaluation and a previously marketed device through modifications by the same manufacturer. Manufacturers must also ensure that the clinical evaluation of the marketed device is sufficient to demonstrate conformity with safety and performance requirements.
Q: What can improve the process of demonstrating equivalence under the EU MDR?
A: Manufacturers should use tables to compare and contrast the devices, clearly stating all differences and critically analysing their potential impact on safety and performance. It’s essential to thoroughly analyse potentially equivalent devices before the transition phase ends and incorporate previous equivalence analyses and clinical data into the process. Additionally, manufacturers must ensure that all pertinent information about comparable products is available for clinical evaluation to prove their effectiveness and safety.
