Europe – European Artificial Intelligence Act (Version 2)
This position paper provides an overview of the Team-NB perspective on the challenges of the AI Act with particular attention to its implementation.
Because of the...
Europe – Best Practice Guidance for the Submission of Technical Documentation under Annex II...
General Considerations
The most common reasons for delays in Technical Documentation assessments by notified bodies are:
• Incomplete Submissions – Insufficient or missing information not provided...
UK – Clinical investigations of medical devices – guidance for manufacturers
It is important to note that the rules for notifying the MHRA of a clinical investigation in
Great Britain (England, Wales and Scotland) differ from...
International – ISO 15223-1:2021/Amd 1:2025 Medical devices — Symbols to be used with information...
A revised EC REP symbol, no longer tied to a specific country or region, supporting broader international use and simplifying labeling for manufacturers operating...
International – Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria and...
The NCAR Exchange Program will be used to exchange information relating to significant concerns or potential trends that individual authorities have observed in their...
International – IMDRF guidance details when regulators should share postmarket surveillance reports
The International Medical Devices Regulators Forum (IMDRF) has issued guidance on when and how regulators should share information about the potential risks of certain...
USA – FDA reissues sex-specific data guidance after sanitizing anything considered DEI-related
As part of President Donald Trump’s directive to eliminate anything construed as related to diversity, equity and inclusion (DEI), the US Food and Drug...
Canada – Health Canada Continues to Actively Monitor Supply of Medical Devices
On March 2, 2022, amendments to the legislation in Canada, Medical Devices Regulations (SOR/98-282, Part 1, Sections 62.21 to 62.26) came into force. These provisions...
Europe – Risk Categorization Per the European AI Act
Article 6 of the AI Act defines the criteria for an AI system to be classified as high-risk. According to paragraph 1(b), an AI...
International – Playbook for Medical Device Regulatory Reliance Programs
This document provides high-level strategies for developing regulatory reliance programs for medical devices, along with specific considerations and steps related to actual program implementation....
