AAMI, BSI and FDA collaborate at international forum

AAMI, BSI and FDA collaborate at international forum

The Association for the Advancement of Medical Instrumentation (AAMI), the US Food and Drug Administration (FDA) and BSI co-hosted the International Conference on medical devices standards and regulation in Arlington, Virginia on 22 and 23 March 2018. The event bought together a variety of speakers to address a broad range of interrelated subjects. The programme provided an opportunity not only to look across a wide rang of topics but also to look in depth at several issues of particular current relevance.

The first session comprised an FDA Regulatory update. It described the work being done to implement FDA initiatives and policies. The proposed reorganization of the FDA Center for Devices and Radiological Health (CDRH) to focus on product lifecycle was presented together with an overview of the FDA programme for the recognition of standards. An accreditation scheme for conformity assessment of laboratories providing certificates of conformity with standards was outlined; this scheme was progressing to a pilot and criteria for this pilot were described. Finally, the FDA digital health strategy covering medical device software was presented and the alignment with work in the International Medical Devices Regulators Forum (IMDRF) highlighted.

The next session focused on international developments with a summary of the other work being undertaken in IMDR. This was followed by an overview of the work on key horizontal standards for quality management systems, risk management, and post-market surveillance.  A panel of speakers addressed recent developments and future thinking in quality management systems, describing:

• the progress in the Medical Devices Single Audit Program (MDSAP),
• the harmonisation of EN ISO 13485,
• the publication of the Handbook on ISO 13485 and CEN Technical Report TR 17223,
• the timelines for completing the transition ISO 13485:2016,
• the implications of the systematic review of ISO 13485 in 2019, and
• FDA acceptance of ISO 13485.

The session on risk management described the developments in the revision of ISO 14971 and the panel on post-market surveillance discussed the divergent terminology used in different parts of the world and the initial efforts in international harmonisation in this area.

The third session focused on the European regulations of medical devices and in vitro diagnostics, focusing on practical implementation issues and timelines, classification and clinical evidence. It also built on the earlier discussions by considering the European regulatory requirements on risk management and post-market surveillance.

Finally, there was a session with a future focus that considered developments in standards and regulatory needs for cybersecurity, artificial intelligence and medical algorithms, and the application of 3-D printing in the medical sector.

AAMI and BSI are collaborating to bring the International Conference on medical devices standards and regulation to Europe. This will be held on 19 and 20 June at the Sheraton Skyline hotel near to London’s Heathrow airport.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.