The IMDRF’s Standards Working Group issued final guidance on optimizing standards for regulatory use, noting that optimized standards offer a way to streamline regulatory processes as medical devices grow in complexity and international markets expand.
The guidance offers recommendations for regulators, standards developing organizations (SDOs) and other stakeholders for improving standards globally. The working group concluded that standards could be improved by engaging with regulators and getting them to participate in groups like IMDRF.
Although regulatory processes among IMDRF regions differ, international consensus standards generally “reflect the best experience of industry, researchers, consumers, regulators and other experts worldwide,” it said. Globally accepted consensus standards are best, but regional, national and consortia standards may be equally useful, especially for emerging technologies for which SDOs “may be able to react quickly to changes in the state of the art.”
The working group identified shortcomings in the way standards are currently written, including problems with representation, decision-making and processes, and a lack of understanding in the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) about what regulators need.
“Discussions with ISO and IEC leadership lead us to conclude that, while challenging, these problems can be resolved” through collaboration, the working group said.
IMDRF outlines three key expectations for developing regulatory-ready standards:
Standards should be crafted in such a way that conformity can reduce the burden of regulatory review, the guidance states. To achieve this, standards content needs to contain “objective and specific requirements that clearly indicate how conformance can be achieved and conveyed.”
At every stage of developing standards, “careful thought should be given to how a standard can be used by regulatory authorities,” and the effect on regulatory practices and industry should be evaluated early on, the guidance suggests.
In justifying the need for a standard, content should clearly identify the purpose in its scope and specify how it will achieve the purpose. Standards developers should carefully study the market, regulatory and safety needs when crafting a business plan. Once drafting is underway, input should be sought from working groups and industry stakeholders.