6/7 October 2021
With a draft document made up of 66 pages, the WHO intends to provide support regarding the introduction and implementation of regulations with regard to medical devices, including in vitro diagnostic medical devices (IVDs). The document is a revised draft whose first version - however - hasn't been published. The document history shows that the revision had become necessary as the first draft was too complicated.
The objective of the document is large: it should provide WHO Members States with a regulatory framework in order to be able to adapt their existing system or to create their own regulatory framework for medical devices. The global interest for medical devices has grown. WHO's document as a model regulatory framework should ensure the quality and safety of medical devices.
The model described in the document delivers not only recommending principles but also harmonised definitions. Concerning this, the document refers to definitions of the Global Harmonisation Task Force (GHTF) respectively of the International Medical Devices Regulator Forums (IMDRF), the successor organisation.
The 66 pages are organised in 5 chapters, one extensive (8 pages) references section, one section with further readings (1 page) and two annexes.
Chapter 1 ("Introduction") explains the purpose of the document and gives an overview.
Chapter 2 (8 pages) sets definitions, explains the potential risk classification to group medical devices (in that case, A to D classes), and describes essential principles for the safety and performance of medical devices. Finally, it provides recommendations for the design process.
Chapter 3 defines in 5 pages the principles of "good regulatory practice" and gives instructions about efficient implementation. Furthermore, tools for the regulatory process are mentioned. The chapter also presents a "Gap Analysis" which should help compare the already existing structures with the model described in the document.
Chapter 4 describes in 20 pages a stepwise approach for the implementation and execution of regulatory controls. Insofar, suggestions are made with regard to a prioritisation of the elements to be introduced.
Chapter 5 (7 pages) defines specific topics to consider like for example borderline matters and the reprocessing of single use medical devices.
Annex 1 includes a 6-page glossary whereas the one-page Annex 2 presents the document hierarchy of regulations.
The WHO Draft Global Model Regulatory Framework for Medical Devices including IVDS describes in a very ambitious manner how medical devices regulations could be implemented. Indeed, this can be helpful for states who don't have any yet. Inversely, for states who already have a legislation and the corresponding regulations for medical devices, it is rather less interesting.