CANADA
Health Canada has a Consultation: Proposed Changes to the Medical Devices Directorate’s List of Recognized Standards for Medical Devices. 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.
SAUDI ARABIA
MDS-REQ 7 – Requirements for Unique Device Identification (UDI) for Medical Devices Version 4
EU
Questions And Answers On Certificates Of Free Sale And Article 60 Of Regulation (EU) 2017/745 On Medical Devices (MDR) – 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 ‘old’, ‘legacy’ 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 was endorsed by the CAMD during the 50th plenary meeting held in Paris in June 2022.
MDCG 2022-11 – MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements – Places FULL responsibility 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.
US
Electromagnetic Compatibility (EMC) of Medical Devices: Final Guidance for Industry and Food and Drug Administration Staff – Issued June 6, 2022, replaces draft of November 17, 2020. NOTE transition period: This document will supersede “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices,” 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.
Webinar Recording (June 14, 2022) on Draft Guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions – The webinar focused on the following key subjects:
- Differences between 2018 and 2022 drafts
- General Principles of the guidance
- Design and documentation recommendations
- Transparency and labeling recommendations
- Answered questions
Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. Feel free to schedule a call with Leo or contact Leo at or through our contact form.