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....
Europe – Pilot on the Advice from the Expert Panels to Manufacturers of HighRisk...
Regulation (EU) 2017/745 on medical devices (Medical Devices Regulation, MDR) Article 106 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (In Vitro...
France – Mesure de glycémie sans piqûre : l’ANSM et la DGCCRF alertent sur...
Le diabète, est une maladie chronique caractérisée par une dérégulation du taux de sucre dans le sang (glycémie) et qui demande un suivi régulier...
Europe – EMA qualifies first artificial intelligence tool to diagnose inflammatory liver disease (MASH)...
EMA’s human medicines committee (CHMP) has issued the first Qualification Opinion (QO) on an innovative development methodology based on artificial intelligence (AI). The tool,...
Europe – Update – MDCG 2020-16 rev.4 – Guidance on Classification Rules for in...
This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic...
Europe – EU device expert warns manufacturers not to wait until the last minute...
AN EU medical device expert advised manufacturers to avoid submitting applications at the last minute for approval under the Medical Devices Regulation (MDR) and the In Vitro...
