IMDRF Finalizes Work on Standards for Regulatory Use, Essential Principles, Personalized Devices

Regulatory NewsRegulatory News | 13 November 2018 |  By 

The International Medical Device Regulators Forum (IMDRF) has finalized three technical documents on optimizing standards for regulatory use, the essential principles of safety and performance for medical devices and in vitro diagnostic devices, and definitions for personalized medical devices.

The work to internationally harmonize medical device regulations through the final technical documents was carried out by the IMDRF standards working group, good regulatory review practices group and the personalized medical devices working group. The documents were coordinated by the US Food and Drug Administration (FDA) and Australia’s Therapeutic Goods Administration (TGA).

IMDRF takes up new work items to address areas in need of harmonization for a globally consistent approach to compliance across all jurisdictions overseen by the participating ten regulatory authorities.

The 24-page final document on optimizing standards for regulatory use argues “standards are frequently written in ways that diminish their utility in regulatory processes” while “other standards are too flexible or unclear in expectations, or do not meet a specific need, either for the market or regulators.” These are the type of challenges that “highlight the importance of considering how medical devices are regulated when building a standard, so that a firm’s declaration of conformity with it will augment reviewers’ confidence and streamline the approval process,” the IMDRF document says. Its recommendations can be used by regulatory authorities and standard development organizations.

The 37-page final document on the essential principles of safety and performance for medical devices and in vitro diagnostic devices “seeks to strike a balance between the responsibilities” of regulators “to the health of their citizens and their obligations to avoid placing unnecessary burdens upon the industry.” The document sets forth harmonized requirements to provide assurance that a device is as safe and performs as the manufacturer intended it to. The requirements are partly based on ISO 13485, which is to undergo a systematic review to implement certain revisions early next year.

The 10-page final document on harmonized definitions for personalized medical devices, when adopted, could “underpin a harmonized regulatory approach for controls on these devices and offer significant benefits to the manufacturer, user, patient and to regulatory authorities.” The approach is ultimately intended to decrease costs associated with regulatory compliance and increase patient access. IMDRF member Health Canada issued new draft guidance earlier this month on licensing 3D-printed implantable medical devices based on the definitions in this document for personalized medical devices.

Other new IMDRF work items already underway are aimed at harmonizing terminology around medical device cybersecurity, the regulatory pathways for personalized devices as well as requirements and procedures to carry out premarket regulatory reviews on device submissions. The European Union is also coordinating new work for a unique device identification application guide as an IMDRF memberb country.


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