Amidst the wave of standards in the AI domain and the intense focus on AI regulation, key developments specific to the MedTech sector may have slipped under the radar.

Here are is a distilled overview of five work items in the domain of medical devices that warrant your attention! 👀

🔹 IEC 62304: This cornerstone standard for Medical Device Software (MDSW) has been approved for revision by a newly formed IEC Maintenance Group (MT). Considered long-overdue by some, this should be on the radar of anyone working with MDSW.

🔹 ISO/TS 24971-2: Offering guidance on the application of Risk Management (i.e., ISO 14971) to AI-enabled medical devices, this new Technical Specification (TS) is based on previous guidance developed in collaboration between AAMI and BSI and is developed in a Joint Working Group (JWG) between ISO and IEC.

🔹 IEC/TS 62366-2: Recognized as a guidance in the application of Usability Engineering to Medical Devices, this document—presently a Technical Report (TR)—was recently approved for revision which includes the conversion into a Technical Specification (TS).

🔹 ISO/AWI 18969: Currently being developed in a Working Group (WG) under ISO, this standard is aimed to be the first covering the highly complex domain of Clinical Evaluation within the MedTech industry, making it one of the more anticipated work items on the list.

🔹 ISO/IEC AWI TR 18988: The scope of this new Technical Report (TR) includes the identification of processes, factors, concepts, and terms related to AI in health informatics.

The prevalent use of abbreviations in standardisation may serve expert members but can make the work surrounding standardization seem like a 'black box' to people outside the committees. If this post has sparked your curiosity, you might wonder:

🔺What is the difference between a Technical Specification (TS), Technical Report (TR) and a International Standard (IS) and how does it affect compliance?
🔺Where is this work undertaken and how does one get involved?
🔺What is the difference between a Maintenance Group (MT), Joint Working Group (JWG) a regular Working Group (WG)?

In a hope to lessen the ambiguity surrounding this work and promote broader understanding, I plan to address these questions and others in upcoming posts - some of which will be in collaboration with Danish Standard and other industry stakeholders. I hope to see you contribute in the comments and join the forthcoming discussions! 🗣️