MDCG 2023-5: Guidance on qualification and classification of Annex XVI products

Introduction

MDCG 2023-5 provides crucial insights into the Regulation (EU) 2017/745 on medical devices (MDR) as it pertains to products without an intended medical purpose, specifically those listed in Annex XVI. Understanding the intricate relationship between the MDR and common specifications (CS) is essential for manufacturers and notified bodies.

The guidance serves as a comprehensive resource for qualifying products without an intended medical purpose under Annex XVI. It elucidates the classification rules, considerations for dual-purpose devices, and practical insights into qualification criteria. The document aims to harmonize understanding, aligning with MDCG 2021-24 on classification and Commission Implementing Regulation (EU) 2022/2347 on reclassification.

Key Takeaways

  • Qualification Criteria: The MDCG emphasizes reliance on Annex XVI descriptions and CS scope sections for product qualification, considering characteristics such as technology, functioning modalities, and intended purpose.
  • Dual-Purpose Devices: Guidance on navigating the requirements for devices claiming both medical and non-medical purposes, highlighting the need for compliance with the most stringent requirements.
  • Classification Principles: MDCG outlines the classification principles for each group of Annex XVI products, addressing nuances such as contact lenses, surgically invasive devices, dermal fillers, and high-intensity electromagnetic radiation-emitting equipment.
  • Practical Qualification Issues: Insights into the challenges of qualification, including examples such as lipolysis laser equipment, equipment for radiofrequency radiation-assisted liposuction, and clarification on terms like “fixation” and “high intensity.”