Analyzing the MDCG 2023-6 Position Paper: A Guide on Equivalence for Annex XVI Products
The Medical Device Coordination Group (MDCG) has released the MDCG 2023-6 guidance document, a beacon for manufacturers and notified bodies operating under the Medical Device Regulation (EU) 2017/745 (MDR). This piece of guidance sheds light on demonstrating equivalence for Annex XVI products, specifically those without an intended medical purpose. Let's delve into the key aspects and implications of this pivotal document.
Understanding the Context
The MDR has significantly raised the bar for clinical evidence and conformity assessment procedures. For products without an intended medical purpose listed in Annex XVI, which includes items like colored contact lenses or equipment intended for liposuction, the path to demonstrating safety and performance is intricate. The MDCG 2023-6 document provides much-needed clarity and direction.
The Essence of the Guidance
Introduction and Applicability:
At the outset, the guidance makes it clear that while clinical investigation is the gold standard for generating clinical data, the concept of equivalence offers an alternative route. However, the document emphasizes that demonstrating equivalence between a medical device and a non-medical product is typically not feasible due to fundamental differences in their intended purposes.Scope of Guidance:
The guidance specifically addresses products without an intended medical purpose as per Annex XVI. This distinction is crucial because it sets the stage for understanding the unique challenges and requirements for demonstrating equivalence for such products. It's particularly pertinent for dual-purpose devices that serve both medical and non-medical functions but focuses solely on the non-medical aspects.Demonstrating Equivalence:
This section is the heart of the guidance. It breaks down the process into several scenarios:
Non-medical vs. Non-medical Products: The document outlines that equivalence needs to be demonstrated according to MDR criteria, considering technical, biological, and clinical characteristics. However, it acknowledges the peculiar challenge that some clinical characteristics inherent to medical devices may not be directly applicable to non-medical products.
Non-medical Products vs. Analogous Medical Devices: In a significant revelation, the guidance notes that generally, a direct comparison between these two is not viable. The inability to compare all clinical characteristics, particularly those related to disease conditions, makes equivalence hard to establish.
Non-medical Products vs. Dual-purpose Devices: Here's where there's a glimmer of feasibility. The guidance suggests that for dual-purpose devices, equivalence can be demonstrated by comparing characteristics related to the non-medical purpose. However, it's crucial that only data pertinent to the general safety and performance requirements for the non-medical purpose are used.
