{"id":7312,"date":"2022-06-30T18:22:00","date_gmt":"2022-06-30T18:22:00","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=7312"},"modified":"2022-07-01T07:12:25","modified_gmt":"2022-07-01T07:12:25","slug":"june-international-regulatory-updates","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2022\/06\/30\/june-international-regulatory-updates\/","title":{"rendered":"June International Regulatory Updates"},"content":{"rendered":"\n
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CANADA<\/strong><\/p>\n\n\n\n

Health Canada has a Consultation: Proposed Changes to the Medical Devices Directorate\u2019s List of Recognized Standards for Medical Devices<\/strong><\/a>. I’m surprised they are not updating any of the IEC 60601 based General and Collateral standards to the most recent updates of the summer of 2020 updates. Even the EMC standard IEC 60601-1-2 is still based on the 4.0 edition which is from 2014 and IEC 60601-1 the list references the 3.0 and 3.1 editions 2005 and 2012 respectively.<\/p>\n\n\n\n

SAUDI ARABIA<\/strong><\/p>\n\n\n\n

Postponement announcement of the requirements timeline of medical devices unique device identification (Saudi -DI)<\/strong><\/a><\/p>\n\n\n\n

MDS-REQ 7 – Requirements for Unique Device Identification (UDI) for Medical Devices Version 4<\/a><\/strong><\/p>\n\n\n\n

EU<\/strong>
Questions And Answers On Certificates Of Free Sale And Article 60 Of Regulation (EU) 2017\/745 On Medical Devices (MDR)<\/strong><\/a> – This document was developed by competent authorities, with the aim of providing guidance in the area of Certificates of Free Sale.
It considers how certificates of free sale should be processed\/ generated for \u2018old\u2019, \u2018legacy\u2019 and MDR compliant devices. It highlights where certificates of free sale can be issued in the context of Article 60 (1) of the Regulation and where the use of national provisions may be required.
The document<\/a> was endorsed by the CAMD during the 50th plenary meeting held in Paris in June 2022.<\/p>\n\n\n\n

MDCG 2022-11 – MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements<\/strong><\/a> – Places FULL responsibility<\/em><\/strong> on manufacturers to complete the transition in time FULL STOP. Don’t expect any extension of the transition period beyond what has been established at this point.<\/p>\n\n\n\n

US<\/strong><\/p>\n\n\n\n

Electromagnetic Compatibility (EMC) of Medical Devices: Final Guidance for Industry and Food and Drug Administration Staff<\/a><\/strong> – Issued June 6, 2022, replaces draft of November 17, 2020. NOTE<\/em><\/strong> transition period:<\/strong><\/em> This document will supersede \u201cInformation to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices,\u201d issued July 11, 2016, 1 year after the publication of this guidance for in vitro diagnostics and 60 days after the publication of this guidance for other device types (e.g. medical devices including home use devices and active implantables) within the scope of this guidance.<\/p>\n\n\n\n

Webinar Recording (June 14, 2022) on Draft Guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions<\/a><\/strong> – The webinar focused on the following key subjects:<\/p>\n\n\n\n