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

Postponement announcement of the requirements timeline of medical devices unique device identification (Saudi -DI)

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Webinar Recording (June 14, 2022) on Draft Guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions – The webinar focused on the following key subjects: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 Leo@EisnerSafety.com or through our contact form.

The FDA on May 30, 2022, same day as when the recent AAMI 60601 Amendments were Recognized, added the Interpretation Sheet 1 (ISH1) – Amendment 1 – on Essential Performance (Clause 4.3) and Single Fault Condition (Clause 4.7) based on IEC 60601-1:2005+A1:2012 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance to:
FDA Recognition # 19-46 ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] and
FDA Recognition # 19-4 ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text).

ISH1 was added to both FDA Recognitions # 19-46 & 19-4 as a “Relevant FDA Guidance and/or Supportive Publications” not as an independent Recognized Consensus Standard.
The ISH1 was Issued 2021-03 by IEC. One reason why FDA probably didn’t include the ISH1 as a Recognized Consensus Standard is because it isn’t an ANSI and AAMI approved standard. A blog post on the ISH1 when it was issued can be viewed here.

The FDA has been reviewing Essential Performance (EP) during submission for many years, since the publication of the 3rd edition of IEC 60601-1:2005 and their Recognition of ANSI AAMI ES60601-1:2005. It was even discussed during the expert panel, May 2018, at the ASCA Workshop, which I was the expert on EP on the panel. So, expect that FDA will review your submission for EP both for the safety and the EMC side of your testing.

Questions you need to consider early in the product development:
* have you identified the clinical functions of your device that are EP,
* have you started your EP analysis,
* has the EP analysis been fully connected with your Risk Management File,
* have you written your EP so it is capable of being tested for the safety and EMC which will be tested differently,
* and so much more…

One of the next steps out of the generation of the ISH1, as noted in the blog post on ISH1, was the formation of the Project Team PT 62A-1 with a goal to generate a technical report IEC TR 60601-4-6 as a guidance document on Essential Performance. PT 62A-1 has been meeting since February of 2022 and been trying to work on figuring out how we want to provide guidance to manufacturers, test houses and regulators on Essential Performance and Faults related to EP. The main reason for this is that we have seen there is so much confusion on this subject by some manufacturers, test houses and regulators and we want to provide a document that will provide a consistent guidance on the concept of Essential Performance and Fault Safety related to EP.

Need help with Essential Performance, 60601 series standards (Medical Electrical Equipment), work thru 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. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

The FDA in a little over a month on 30 May 2022 (that is swift) has updated the Recognized Consensus database for the AAMI 60601 Amendmended Standards that are referenced in my previous post of May 13, 2022. The AAMI standards were published in late March 2022.

Not each Recognition was updated in the same way. Let me explain:

FDA Recognition # 19-46 ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] – the ANSI AAMI ES60601-1 AMD2:2021 is identical to Amendment 2:2020 of IEC 60601-1:2005 (post corrected 13 June)

FDA Recognition # 19-47 ANSI AAMI HA60601-1-11:2015 [Including AMD1:2021] – the ANSI AAMI HA60601-1-11 AMD1:2021 is identical to AMD1:2020 of IEC 60601-1-11:2015 (post corrected 13 June)

FDA Recognition # 19-36 ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] –  the ANSI AAMI IEC 60601-1-2:2014 Including AMD 1:2021 is identical to AMD1:2020 of IEC 60601-1-2:2014

FDA Recognition # 5-131 ANSI AAMI IEC 60601-1-8:2006 and A1:20012 [including AMD2:2021] – the ANSI AAMI IEC 60601-1-8:2006 and A1:20012 including AMD2:2021 is identical to Amendment 2:2020 of IEC 60601-1-8:2006

FDA Recognition # 19-39 ANSI AAMI IEC 60601-1-12:2016 [Including AMD 1:2021] –  the ANSI AAMI IEC 60601-1-12:2016 Including AMD 1:2021 is identical to AMD1:2020 of IEC 60601-1-12:2014

Need Help?

Need help with 60601 standards (Medical Electrical Equipment), work thru 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. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.