The International Medical Device Regulators Forum (IMDRF) has released final guidances on optimizing standards for regulatory use, essential principles of safety and performance, and definitions for personalized devices.
Following up on the forum’s Sept. 18-20 meeting in Beijing, the Standards Working Group issued guidance on optimizing standards for regulatory use, noting that optimizing standards will help to streamline regulatory processes as medical devices grow in complexity and international markets expand.
Most IMDRF regions have developed programs for consensus standards, and they have more in common than differences, which sets the stage for future harmonization, the working group said.
The guidance includes recommendations for regulators, standards developing organizations (SDOs) and other stakeholders for improving standards globally.
The working group is conducting a survey among regulators to better understand policy differences and to lay the groundwork for future best practices guidance. It plans to:
Standards optimized for regulatory use will lead to greater confidence in their utility among regulatory authorities and in conformity assessment, the guidance says. Optimized standards will streamline the device review process, improve the efficiency of regulation and establish productive dialog among regulators, manufacturers, conformity assessment organizations, clinicians and the public.
Although regulatory processes differ among IMDRF regions, 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” (IDDM, Oct. 26, 2018).
Harmonized Essential Principles
IMDRF’s Good Regulatory Review Practices Group released final guidance on the Essential Principles of Safety and Performance of Medical Devices and IVDs, with harmonized principles for designing and manufacturing devices to ensure they are safe and perform as intended.
The document is for regulatory authorities, conformity assessment bodies, industry and other stakeholders. Essential principles of safety and performance provide broad, high-level criteria for design, production and post-production throughout the device lifecycle.
IMDRF says standards being considered as part of regulatory compliance can benefit from the essential principles of safety and performance.
The essential principles cover clinical evaluation; chemical, physical and biological properties; sterilization and microbial contamination; environmental considerations and conditions of use; protection against electrical, mechanical and thermal risks; medical devices that incorporate software or are software as a medical device; devices and IVDs with a diagnostic or measuring function; labeling; and protection against radiation.
Definitions for Personalized Medical Devices
IMDRF’s Personalized Medical Devices Working Group released definitions for devices intended for a particular individual.
Many regulators already define the term custom-made medical device and have exempted them from certain regulations. But technology has made custom-made devices, including implantable devices for particular patients possible, so this approach means that patients are receiving higher risk devices that may be exempted from regulation.
The guidance distinguishes between personalized medical devices and custom-made medical devices. Personalized devices describe devices intended for a particular individual, but custom-made devices are not patient-matched, the guidance says.
It also defines patient-matched devices and adaptable medical devices and provides specific examples and recommendations for interpreting the guidance.
Read the guidance on optimizing standards here: www.fdanews.com/11-15-18-IMDRFOptimizingStandards.pdf.
Read the guidance on safety and performance here: www.fdanews.com/11-15-18-IMDRFSafetyPerformance.pdf.
Read the guidance on personalized medical devices here: www.fdanews.com/11-15-18-IMDRFPMD.pdf.