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EU: Medical devices – expansion of the list of well-established technologies    The European Commission has issued a new delegated regulation under the Medical Devices Regulation (MDR). This initiative proposes to broaden the list of well-established technologies (WET) referenced in Regulation (EU) 2017/745, aiming to exempt these devices from certain legal requirements and thereby reduce...

Canada: Updates to Medical Devices Regulation   Canada has published Regulations Amending the Medical Devices Regulations. This proposal implements Phase II of Health Canada’s commitments outlined in the Departmental Forward Regulatory and Stock Review Plans to modernize the Medical Device Establishment Licensing (MDEL) framework, while enhancing oversight to better address emerging health and safety risks....

Mexico: Draft Mexican Official Standard PROY-NOM-241-SSA1-2024, Good manufacturing practices for medical devices   Mexico has published an interpretative guidance for the Draft Mexican Official Standard PROY-NOM-241-SSA1-2024, Good manufacturing practices for medical devices. Interpretation Criteria for the Mexican Official Standard NOM-241-SSA1-2025: Good Manufacturing Practices for Medical Devices For the purposes of Section 5 and any sections...

Mexico: Draft Mexican Official Standard PROY-NOM-241-SSA1-2024, Good manufacturing practices for medical devices.   Mexico has published two additional documents with regard to the Draft Mexican Official Standard PROY-NOM-241-SSA1-2024, Good manufacturing practices for medical devices. – Agreement issuing Guidelines for the submission of documents guaranteeing good manufacturing practices for pharmaceuticals, medicines, and medical devices accompanying applications...

Messico: nuova regolamentazione per i dispositivi medici Il Messico ha pubblicato una bozza dello standard ufficiale messicano PROY-NOM-137-SSA1-2024 sull'etichettatura dei dispositivi medici. Il progetto di norma ufficiale messicana notificato è obbligatorio in tutto il territorio messicano per gli stabilimenti coinvolti nella produzione, confezionamento, distribuzione e importazione di dispositivi medici da commercializzare o fornire in Messico. Il notificato...

EU: Longer transition period for the Medical Devices Regulation   EU published a Proposal for a Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. Regulation (EU) 2017/745 on medical devices (MD Regulation) and Regulation (EU) 2017/746 on in vitro diagnostics...

EU: New Guidance on the difference between medical devices and medicinal products   The EU Medical Device Coordination Group has published a new document: A Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices. The reason for this guidance is a blurred difference between the two legal definitions:...