For more than 20 years, the Global Harmonisation Task Force (GHTF) has promoted the international harmonisation of medical device regulation, involving key stakeholders from the national medical device regulatory authorities and the regulated industry. However, after a final conference meeting the GHTF website is now closed (as of November 2012) and web users can now only see a statement directing them to the organisation replacing the GHTF: the International Medical Device Regulators Forum (IMDRF). This article covers the replacement of the GHTF with the IMDRF and the current status of the international guidance documents that are recognised by most Regulatory Authorities.
Taking up the challenge
The IMDRF was created in October 2011 with the explicit aim to direct and accelerate the convergence of international medical device regulations. In contrast to the GHTF, the participating members are now only the regulatory authorities. The GHTF established the basics of a model for medical device regulation that could be adopted by any regulatory region globally, and had some similarities to that in the EC Directives. The IMDRF aims to build upon this foundation but with the focus on critical regulatory practices that can be discussed specifically by the regulators.
The inaugural IMDRF chair and secretariat is Australia and the current members are: Australia, Brazil, Canada, Europe, Japan, and the USA. The membership of China and the Russian Federation is currently being confirmed. The World Health Organization (WHO) is an official observer while the Asian Harmonisation Working Party (AHWP) is an affiliate organisation.
Although IMDRF membership is restricted to regulators, a broader range of stakeholders are being included in working groups to develop existing GHTF documents and develop new IMDRF documents.
The next meeting of IMDRF will take place March 2013, in France. Details of the Stakeholder Session will be available on the IMDRF website in due course.
Guidance documents: an important resource
An important role of the IMDRF has been to develop a strategy for the management and maintenance of the previous GHTF documents. All current GHTF and new IMDRF documents are available on the IMDRF website, providing an important resource for manufacturers.
As a reminder, some of the most useful documents for manufacturers from GHTF include:
- SG1 Essential Principles of Safety and Performance of Medical Devices (GHTF/SG1/N68:2012)
- SG5 Post-Market Clinical Follow-Up Studies (GHTF/SG5/N4:2010)
- SG5 Clinical Evidence for IVD Medical Devices (GHTF/SG5/N6:2012)
- SG3 Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers (GHTF/SG3/N17:2008)
- SG3 Quality Management Systems – Process Validation Guidance (GHTF/SG3/N99-10:2004)
New final documents from the IMDRF itself are currently limited to terms of reference and position statements, but working items have already been defined and progressed. In the near future, draft documents focussing on topics such as those below are expected from the IMDRF:
- Implementation of UDI system
- Medical Devices Single Audit Program
- Regulated Product Submission project
Guidance documents from IMDRF are going to continue to be an important resource for manufacturers who wish to understand and anticipate developing global regulatory requirements.
Current GHTF and IMDRF documents can be found on the IMDRF website.