IMDRF Roundup: 3D Printing, Global Registries, SaMD

The International Medical Device Regulators Forum agreed to a new work item proposal to develop technical documents that support a harmonized approach to defining devices manufactured for individual patients.

Elizabeth McGrath, director of the Conformity Assessment Branch of Australia’s Therapeutic Goods Administration, proposed the new work item to the management committee during the Sept. 19-21 meeting in Ottawa, Canada.

McGrath said it is now possible to mass produce individualized medical devices using 3D printing, and as individual regulators are now developing their own approaches, there is a risk of international divergence. She proposed that a task force:

• Address the differences between custom-made, customized and patient-specific devices and provide definitions for each;
• Address medical devices that are manufactured in a repeatable manner, especially those produced via additive manufacturing;
• Consider devices that are intended by the original manufacturer to be modified to suit an individual after the device is supplied; and
• Recognize that some devices are produced in a unique manner, and should continue to be eligible for existing custom-made exemptions.

International Registries

The IMDRF management committee also approved a proposed document, “Tools for Assessing the Usability of Registries in Support of Regulatory Decision Making,” which the forum’s Patient Registry Working Group will circulate for public consultation.

By coordinating internationally on methodologies for collecting and evaluating clinical data, international stakeholders can begin to develop a core dataset for evaluating device product life cycles to detect signals earlier. Registries could be used to apply comparative effectiveness data as well as for root cause analyses (IDDM, April 10).

The management committee also approved a final document that covers terminologies for categorized adverse event reporting that covers Annex B to D. Annex B discusses the type of investigation, such as testing of the device and trend analysis, while Annex C looks at investigation findings (whether the problem was biological, microbial, etc.); and Annex D considers the investigation conclusion and whether the cause of the problem is traced to device design, manufacturing or a quality control deficiency.

More information on this work group and final meeting items will be released shortly.

Software as a Medical Device

IMDRF also finalized a document outlining steps required to generate clinical evidence of effectiveness and safety of software as a medical device (SaMD). The document addresses stand-alone software designed to produce or extract data, including diagnostic information, in tandem with a medical device. SaMD is not part of a device, nor is it used to operate a device, and would run on general-purpose computing platforms.

Global Regulator Update

Erik Hansson, deputy head of the Health Technology and Cosmetics unit of the European Commission updated the IMDRF meeting on the EU’s new medical device regulations that will be progressively implemented for medical devices by May 2020 and for IVDs by May 2022 (IDDM, March 13).

Getting EU notified bodies established remains a top priority as does setting up the Medical Device Coordination Group, which will be the main body supporting the Commission for implementing future regulations. The group comprises representatives from EU national authorities and is chaired by the EC.

Japan’s Ministry of Health Labor and Welfare and its Pharmaceuticals and Medical Devices Agency noted that it has designated 14 notified bodies to undertake medical device certification activities.

Japan is introducing conditional early approval schemes for innovative medical devices. The idea is to accelerate approval of devices that have high clinical needs by balancing pre- and postmarket requirements.

Meanwhile, Health Canada said it would use more real-world evidence in its regulations to improve device safety and effectiveness and to improve product lifecycle information.

The Canadian agency is also developing a targeted review process for digital health technology, as well as tools and processes to improve pre-submission meetings for devicemakers.

The next IMDRF meeting will be held in Shanghai in March 2018. The IMDRF management committee includes regulators from Australia, Brazil, Canada, China, the EU, Japan, the Russian Federation, Singapore, and the United States.