The ninth meeting of the management committee of the International Medical Device Regulators Forum (IMDRF) took place in Brasília, Brazil, from 8 to 10 March 2016 and included high-level updates on how the group’s seven current work items are progressing and how device regulations are continuing to converge at the international level.
Originally launched as the Global Harmonization Task Force (GHTF) in 2012, the IMDRF is composed of regulators from Australia, Brazil, Canada, China, EU, Japan, Russia and the US, while representatives of the World Health Organization (WHO) and Asia-Pacific Economic Cooperation (APEC) are official observers and the Asian Harmonization Working Party (AHWP) and Pan American Health Organization (PAHO) are affiliate organizations.
Current IMDRF work items include:
1. Medical Device Single Audit Program (MDSAP)
2. National Competent Authority Report (NCAR)
3. Software as a Medical Device (SaMD): Clinical Evaluation
4. Regulated Product Submission (RPS)
5. Patient Registries
6. Adverse Event Terminology
7. Good Regulatory Review Practices - Competence and Training Requirements for Pre-market Reviewers and Product Specialist
Two new work items were proposed at this latest meeting in Brazil to improve the quality of international medical device standards for regulatory use from the EU (which incorporates DITTA’s previous proposal “Guideline - Medical Device standards for regulatory purpose”) and the development of common terminology and code related to adverse events of devices from the Japanese regulators at the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labour and Welfare (MHLW).
In the individual presentations from the two-day meeting, each of the various regulators used their time to update the others on new and recent regulatory developments.
The European Commission’s Erik Hansson told IMDRF that seven trilogues on the revised EU medical device legislation have taken place since 13 October 2015, with the European Parliament and Council still ironing out issues on:
- Pre-market control of high-risk medical devices;
- Reprocessing of single-use medical devices;
- Use of hazardous substances;
- Counselling and informed consent in the case of genetic tests;
Political agreement on the revised regulation is expected by mid-2016.
As for the US Food and Drug Administration (FDA), Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), told IMDRF about CDRH’s strategic priorities for 2016 and 2017, as well as updates on establishing a national evaluation system for medical devices in the US to “generate and use robust real-world data in an efficient manner to quickly identify new safety problems for devices.” Shuren also touched on new guidance from FDA and two final orders on surgical mesh to repair pelvic organ prolapse trasvaginally and new requirements for submitting PMAs for metal-on-metal hip replacement devices.
Industry group DITTA also offered an update on good refurbishment practices, outcomes on its workshop on medical software and views on IMDRF’s work items, including some questions on the role patient registries can play to support regulatory decisions and/or market access.
On the MDSAP front, an update on the pilot program from Brazilian regulator Fabio Quintino revealed that the number of participating manufacturing firms has almost doubled since August and increased by 20 in January and February.
In addition, officials from PAHO, WHO, Mercosur and all of the member regulators presented on their respective regions.
The next IMDRF management committee meeting will be also held in Brazil (city to be determined) from 13 to 15 September 2016.
Presentation Archive from IMDRF Meeting 8-10 March 2016