Module 5 Presentations

16/07/2024

Governing Regulations for Investigational Products (EU)

Medicinal products (Drugs)

Software as a Medical Device (SaMD)

Integral Drug Device Combination

In-Vitro Diagnostic (IVD)

Non-integral Drug Device Combination

Companion Diagnostic (CDx)

Medical Device

IVDR (replaced IVDD/ National Law after May 26, 2022)

MDR (replaced MDD May 2021)

CTR (replaced CTD after Jan 2022)

M-GB-00018492 Date of preparation: July 2024

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Description of Device Types

SaMD Software as a Medical Device

Software (app, program, website, or service ) that is intended to be used for one or more medical purposes, that performs these purposes without being part of a hardware device. A SaMD can be a component of a DHT. As the name implies, SaMD is regulated as a medical device. Digital Health Technology means a solution made up of computing platforms, connectivity, software and/or sensors for healthcare and related uses. These technologies span a range of products, from general wellness applications to wearable medical devices. These products might be used as diagnostics, therapeutics or adjuncts to medical products. They may also be used to develop or study medical product, or to monitor disease. They may or may not be regulated as medical devices. A non-drug component that is part of an integrated healthcare solution or used in a drug clinical trial. They may or may not be regulated as medical devices.

DHT Digital Health Technology tools

Physical devices w/ or w/o digital

IVDs including Companion diagnostics

An IVD (in-vitro diagnostic) is a medical device used to perform diagnostic tests outside the body in a clinical trial or clinical practice.

Drug Delivery Combination Products

A medical product made up of multiple components but regulated as a single entity - most commonly, a drug delivery product that is regulated and sold together with the drug.

M-GB-00018492 Date of preparation: July 2024

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