Module 17 2024

05/12/2024

Chapter 1: Scope of the Regulations

Definitions of a medical device have been changed. MHRA will continue to provide guidance on “borderline” devices. Clarification on the definition of “Intended Purpose” Products without an intended medical purpose are now included in requirements (very similar to MDR Annex XVI devices). Exclusion of products that contain viable biological substances Exclusion of Food

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Chapter 2: Classification

These changes are in line with the changes made in the move from MDD to MDR. The following changes will be made to the classification rules: • Active implantable medical devices and their accessories to be classified as Class III • In-vitro fertilisation (IVF) and assisted reproduction technologies (ART) to be classified as Class III • Surgical meshes to be classified as Class III • Total or partial joint replacements (except ancillary components such as screws, wedges, plates and instruments) to be classified as Class III • Spinal disc replacement implants and implantable medical devices that contact the spinal column (except ancillary components such as screws, wedges, plates and instruments) to be classified as Class III

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