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[Emergo, UL] Switzerland Continues Efforts to Recognize Non-European Regulatory Authorizations

In November 2022, the Swiss Federal Assembly voted to approve Motion 20.3211 (link in French), which mandated the Swiss Federal Council to adopt regulations to allow medical devices authorized by non-European regulators — namely, the United States (U.S.) Food and Drug Administration (FDA) — to enter the Swiss market. At its meeting on April 30, 2025, the Federal Council defined guidelines for im..

MIR version 7.3.1 is releasedThe European Commission (EC) has at last released (May 5) the long-awaited version 7.3.1 of the Manufacturer Incident Report (MIR) form to report serious incidents. Additionally, the EC has also published a new help text file with information on completing the new report form, as well as the corresponding XSD and XML schema files to facilitate the integration of comp..

The U.S. Food and Drug Administration (FDA) has announced (May 6) that the Office of Inspections and Investigations (OII) will expand its program (pilot) of unannounced inspections beyond India and China. As we reported earlier this year, the FDA has the authority to perform both announced and unannounced inspections. In general, inspections of relevant entities in the U.S. have been unannounced..

The medical device regulator in South Africa, the South African Health Products Regulatory Authority (SAHPRA), announced two important Quality Management System (QMS) developments.SAHPRA joins MDSAPSAHPRA announced (April 4, 2025) affiliate member status has been bestowed upon the Medical Device Single Audit Program (MDSAP). SAHPRA Chief Executive Officer Dr. Boitumelo Semete-Makokotlela hailed ..

Including representative and intended users for a human factors (HF) validation test provides invaluable data for manufacturers because participants’ performance data can demonstrate a product’s expected safety and effectiveness once it is in the market. However, it can also be extremely difficult, or nearly impossible, to recruit exact users for a particular product due to the rarity of a condi..

We reported in August of 2024, about the publication of a revised draft of the Mexican Standard for Good Manufacturing Practices for Medical Devices, titled PROY-NOM-241-SSA1-2024. In Mexico, a Norma Oficial Mexicana (Official Mexican Standard, NOM), is compulsory. We discussed some of the notable changes proposed by COFEPRIS in contrast with the previous 2021 version of the standard, subject to..

The 2025 International Symposium on Human Factors and Ergonomics in Health Care was held in Toronto and included upwards of 700 attendees across the 4-day program, including a day specifically dedicated to the second annual Healthcare Robotics Summit. The summit was a huge success, bringing together human factors practitioners, researchers, students and clinicians in a collaborative environment ..

The U.S. Food and Drug Administration (FDA) has opened the test submission phase of the new Electronic Submission Gateway NextGen system (ESG NextGen) in preparation for the official launch at 9:00 a.m. ET on April 14, 2025. The testing phase will conclude after April 11, and the existing (legacy ESG) system will be disabled at midnight Eastern time (ET) on April 12. No submissions can be made i..

The Australian Therapeutic Goods Administration (TGA) has announced that its Unique Device Identification (UDI) regulatory framework is now in effect following the approval of the Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025. Additionally, the TGA has published new guidance and updated its website to reflect the co..

Our webinar on the European Artificial Intelligence Act Regulation 2024/1689 emphasized the importance of risk categorization per the Medical Device Regulation (MDR, 2017/745) and In-Vitro Diagnostic Regulation (2017/746 IVDR) and the AI Act.The AI Act is now part of the new legislative frameworkThe AI Act is a new part of the new legislative framework and also applies to medical devices and IVD..