The International Medical Device Regulators Forum released updates from its working groups on good regulatory review practices, unique device identifier harmonization, adverse event terminology and standards.
The Good Regulatory Review Practices Working Group reported on its efforts on harmonizing premarket requirements to improve efficiency in premarket reviews. The group is working on a proposed document on essential principles of safety and performance of medical devices and in vitro diagnostics.
The group is updating the document to reflect key changes of the EU Medical Device Regulations and ISO 16142. The work will streamline device and IVD requirements, update requirements for software as a medical device (SaMD), cybersecurity and performance characteristics of IVDs.
In addition, the working group is updating IMDRF’s labeling and the instructions-for-use document based on global updates. It plans to submit a draft document in May.
Global Harmonization for UDI
The Unique Device Identifier Applications Guide Working Group is developing a globally harmonized approach to applying a UDI system. A preliminary draft is currently under review, covering responsibilities for establishing and maintaining a UDI, placement of UDI on all packaging and labeling, use of UDI in forms and databases, and general principles for implementing a UDI system and database.
The working group intends to consider the draft at its June teleconference and a final document could be available by December 2018.
The IMDRF’s Adverse Event Terminology and Coding Working Group released updated IMDRF terminologies for categorized AERs in September 2017, but three additional annexes are now at the consultation stage, covering health effects terms and conditions that are based on FDA terms and refer to MedDRA.
The move aligns with the FDA’s plans to update its adverse event codes this spring and to deploy CDRH’s electronic medical device reporting system and eSubmitter software.
Code hierarchies posted on FDA.gov are linked to IMDRF codes as the agency ultimately plans to harmonize all other adverse event codes with IMDRF terminologies.
IMDRF’s Standards Working Group released a consultation document on optimizing standards for regulatory use which the forum believes can help harmonize international standards. The document covers essential principles of safety and performance, as well as the use of consensus standards.
The Patient Registries Working Group issued a final document on tools for assessing the usability of registries in support of regulatory decision making. The document provides guidance to regulators for using patient registries to make decisions on device approvals, expanded indications, and post-marketing surveillance, as well as on performance criteria (IDDM, April 16).