26/27 May 2021
On 76 pages spread over five chapters, the WHO has published a finalised regulatory framework for medical devices, including In-vitro-Diagnostics (IVDs), with the title "WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices". We reported on the draft in 2016: "WHO publishes Second Draft of a Global Medical Devices Regulation".
It particularly addresses countries that do not have their own regulations for medical devices. The main parts of the document reference the Global Harmonisation Task Force (GHTF) as well as the International Medical Device Regulators Forum (IMDRF).
Chapter 2 recommends definitions for medical devices and IVDs. It also describes how medical devices may be classified in accordance with their risk potential and how manufacturers may demonstrate the competent authority that their medical devices have been designed and manufactured appropriately. The classification is divided into A (low risk), B (low to moderate risk), C (moderate to high risk) and D (high risk). It shows in a table how a "Conformity Assessment" may look depending on the risk classification.
Chapter 3 introduces the principles of "Good Regulatory Practice" and requirements of its implementation. It names essential tools for the regulation of medical devices and IVDs as well as the resources required.
Chapter 4 then introduces approaches for regulatory controls step by step, starting from very simple approaches to an elaborate level. The different approaches/levels are described respectively for pre-marketing, marketing and post-marketing activities.
Aspects also to be considered are outlined in chapter 5. Those are, for example, definition issues with other products (borderline products) such as cosmetics, personal safety equipment, etc. It also addresses questions related to the reprocessing of single use products and the handling of falsified products. Information on references, further literature and an appendix describing the hierarchy of regulations (laws vs. guidelines) conclude the document.
Details can be found in the document "WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices" of the WHO Medical device technical series.