Guidance on essential principles for medical devices available for comment

IMDRF guidance aims to harmonize documentation and procedures

International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world. It has just published for consultation a revised guidance document on essential principles of safety and performance for medical devices.  The purpose of this guidance is given as ‘to harmonize the documentation and procedures that are used to assess whether a medical device conforms to the regulations that apply in each jurisdiction’.

This document has been developed to encourage regulatory requirements around the world to converge. Eliminating differences between different countries and regions should decrease the cost of meeting regulatory requirements.  It should also increase speed-to-market of new technologies and treatments. The guidance tries to balance safeguarding the health of patients and users of medical devices with avoiding unnecessary burdens on manufacturers.

This guidance describes fundamental design and manufacturing requirements, called ‘Essential Principles of Safety and Performance’.  These principles describe features that show that a medical device is safe and performs as intended. Essential principles of safety and performance provide broad, high-level criteria for the life-cycle of medical devices.  Annex A of the guidance addresses the use of standards in meeting the essential principles. This annex indicates that consensus standards can provide a greater level of detail and specificity than the essential principles. Standards that contain detailed requirements can be used to demonstrate conformance with the essential principles. Some Regulatory Authorities allow use of standards as one means of demonstrating compliance with relevant essential principles.

The manufacturers of medical devices or in vitro diagnostics (IVDs) are expected to design and manufacture products that are safe and perform as intended throughout its life. The essential principles can be considered during the design and manufacturing process. Typically, they would be considered as design and development inputs within the manufacturer’s quality management system. Verification and validation that the design and development outputs meet these inputs should demonstrate that these principles have been met.

The IMDRF essential principles parallel the approach of the General Safety and Performance Requirements in Annex I of each of the European Medical Devices Regulation and IVD Regulation. However, it is important to note that there are differences between the IMDRF essential principles and the EU general safety and performance requirements. For example, in terms of risk, the IMDRF document requires risks be reduced ‘as far as possible and appropriate’ and that this means ‘as low as reasonably practicable without adversely affecting the benefit-risk determination’; the EU MDR and IVDR, in contrast, state ‘reduction of risk as far as possible’ and that this means ‘without affecting the risk-benefit ratio’.

The consultation on the IMDRF guidance is set to run until 18 April 2018. Now is the time to review and provide comments. On adoption this document will supersede an earlier version published in 2012 by the Global Harmonization Task Force.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.