Reclassification of medical devices that are substances to be introduced into the body or applied to and absorbed by the skin

This guidance aims to assist sponsors of medical devices that are substances for introduction into the body with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021, medical devices that are substances for introduction into the body will be required to meet regulatory requirements demonstrating the safety and performance for Class IIa (low-medium risk) or Class IIb (medium-high risk) devices.

This guidance is specific to medical devices that are composed of substances or of combinations of substances that are intended to be introduced into the body via a body orifice or applied to and absorbed by the skin.

What substances fall within scope of the new regulations?

• For devices that are introduced into the body via an orifice: those that tend to be locally dispersed upon application and rely on their inherent physical or mechanical properties to perform their therapeutic function. While some of these devices may appear similar in formulation and physical attributes to medicinal products, the important distinction is that they do not achieve their principal intended action by pharmacological, metabolic or immunological means.
• For devices that are substances applied to and absorbed by the skin: those that tend to be locally absorbed. Substances which act via systemic absorption would generally be medicines, although any systemic absorption of a device should be considered for safety.

The following devices are not in scope of this regulation:

• Invasive medical devices intended to be used by penetration of body orifices that generally do not locally disperse and depend on an external action or manipulation to achieve their intended purpose (e.g., tongue depressors, dental impression materials or intragastric balloons).
• Surgically invasive medical devices (e.g., surgical instruments, absorbable sutures)
• Non-invasive medical devices that are intended by the manufacturer to be used in contact with injured skin or a mucous membrane that are not absorbed (for example, wound dressings)

Download the guidance