New WHO Guideline for Medical Devices and IVDs

After issuing the second draft of a Global Medical Devices Regulation, the WHO has published a finalised 76-page regulatory framework for medical devices including in vitro diagnostic medical devices (IVDs) divided into 5 chapters. It is entitled "WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices".  What is the purpose of this document?

It is intended mainly for those countries that have no regulations on medical devices of their own. The main parts of the document refer to the Global Harmonisation Task Force (GHTF) and the International Medical Device Regulators Forum (IMDRF).

Chapter 2 recommends definitions of medical devices and IVDs. Furthermore, it describes how medical devices can be classified according to their risk potential and how manufacturers can demonstrate to authorities that their medical devices are designed and produced appropriately. The classification ranges from A (low risk) via B (moderate risk), C (moderate to high risk) up to D (high risk). A "conformity assessment" according to the respective risk class is demonstrated by means of a table.

Chapter 3 presents principles of "good regulatory practice" and the requirements to implement them. It lists essential tools for the regulation of medical devices and IVDs and the required resources.

In chapter 4, approaches to regulatory control are successively presented, starting from very simple approaches up to an extensive level. It describes the varying approaches/levels for activities before placing on the market, marketing activities and post-marketing activities.

Chapter 5 describes additional aspects to be considered. These are distinction issues to other products (borderline products) for instance - such as cosmetics, personal protective equipment etc. Questions on the reprocessing of single-use medical devices and the handling of falsified products are also addressed. The document ends with information on credentials, further reading and an appendix describing the hierarchy of regulations (rules vs. guidelines).

You will find the details in the "WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices".

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