Join me, Leo Eisner, The IEC 60601 Guy, as I lead an interactive and fun workshop at the 10X Medical Device Conference in Newport Beach, Ca on May 7 – 8, 2025. Turn Medical Device Standards into Your Competitive Advantage, and discover practical strategies to leverage standards, avoid costly errors, and accelerate your product development cycle.

Don’t make the 5 costly mistakes companies make with Medical Device Standards. Learn from the IEC 60601 Guy himself.:

• Late Identification of Applicable Standards: Leads to expensive redesigns and delayed timelines
• Ignoring Expert Standards Guidance: Results in regulatory rejections and costly resubmissions
• Unprepared Risk Management File for Testing: Risks unnecessary costs due to lack of strategic planning for compliance.
• Unprepared Regulatory Submissions: Leads to costly setbacks and market-entry delays
• Underestimating Education and Training: Creates knowledge gaps, increasing errors and compliance risks.

I want to thank Sean Smith and his team from 10X for all his help and dedication for putting on this event. He is doing an amazing job and please contact him if you are interested.

Need help with standards?

We provide support for your design and development process for regulatory submissions.? Eisner Safety Consultants can help by

• Assisting with strategic compliance planning for your medical electrical product lines,
• Providing regulatory support when FDA or a regulator asks technical questions on your submission.
• Identification of applicable standards, laws, regulations, guidances, and directives up front to support your design process effectively.
• Design Documentation Reviews providing expert analysis supporting the design development process to avoid unnecessary design and development delays.
• We provide EU, US, and other countries regulatory requirement reviews of standards, laws, directives, and guidance.
• Providing support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs, and more.
• Interfacing with test houses for medical safety, EMC and arrange other testing.

Feel free to schedule a web meeting with Leo or contact us.

Join us for the fifteenth 10x Medical Device Conference on May 7 to 8, 2025 – Hyatt Regency Newport Beach, CA

What’s 10x 2025 about you ask?

• The focus is on building meaningful relationships and tackling real challenges
• Move through key stages of the MedTech lifecycle. Each workshop station focuses on critical topics such as:
  • Regulatory Pathways
  • Cybersecurity
  • Engineering
  • Product Development
  • Market Access
  • Reimbursement
  • Commercialization

Join experts Carrie Britton, Matthias Fink, Sean Smith, Jan Gates, Angelina Lisandrelli, Jose Bohorquez, and others experts for a journey through the MedTech lifecycle – from ideation to marketed product. Each workshop represents a stage of this journey, offering opportunities to collaborate, ask questions, and exchange expertise.

Thank you, Sean for including me on this impressive list of experts for 10x this year!

Looking forward to seeing you in Newport Beach, CA. – Seats are limited

Join us for this very personalized experience and Joe Hage‘s Ice Cream Social

𝗕𝗥𝗘𝗔𝗞𝗜𝗡𝗚 𝗡𝗘𝗪𝗦 𝗜𝗠𝗗𝗥𝗙 𝗡𝟰𝟳 & 𝗡𝟱𝟮 recently updated to 𝗘𝗱𝗶𝘁𝗶𝗼𝗻 𝟮 – 𝗪𝗵𝗮𝘁’𝘀 𝘁𝗵𝗲 𝗿𝗲𝗹𝗮𝘁𝗶𝗼𝗻𝘀𝗵𝗶𝗽 𝘁𝗼 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭-𝟭, 𝟰𝘁𝗵 𝗲𝗱

IMDRF N47 & N52 both have been updated which will support Regulatory Submissions and Compliance Testing for the future of the IEC 60601 series including IEC 60601-1, 4^th edition. 𝗜𝗠𝗗𝗥𝗙 𝗽𝘂𝗯𝗹𝗶𝘀𝗵𝗲𝗱 two Final documents on 𝟮𝟲 𝗔𝗽𝗿𝗶𝗹 𝟮𝟬𝟮𝟰, both to Version 2:
N47 Essential Principles of Safety and Performance of Medical Devices & IVD Medical Devices, and
N52 Principles of Labeling for Medical Devices and IVD Medical Devices

The 𝗽𝘂𝗿𝗽𝗼𝘀𝗲 𝗼𝗳 𝗡𝟰𝟳 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲 is to provide harmonized Essential Principles that should be fulfilled in the design & manufacturing of medical devices and in vitro diagnostic (IVD) medical devices to ensure that they are safe and perform as intended.  The worldwide adoption of a common set of fundamental design and manufacturing requirements for medical devices that, when met, provide assurance the device is safe and performs as intended, offers significant benefits to, among others, manufacturers, users, patients/consumers, and to Regulatory Authorities.  Reducing differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments.

While 𝗡𝟱𝟮 𝗹𝗲𝘃𝗲𝗿𝗮𝗴𝗲𝘀 𝗼𝗻 𝗡𝟰𝟳 𝗮𝘀 𝗶𝘁’𝘀 𝗽𝘂𝗿𝗽𝗼𝘀𝗲 states this guidance is to provide globally harmonized labeling principles for medical devices, including in vitro diagnostic (IVD) medical devices, and support N47.  Specifically, this document provides guidance on the content of the label, instructions for use, and information intended for the patient in order to support the safe and effective use of medical devices and IVD medical devices by their intended users.

With the 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭-𝟭, 𝟰𝘁𝗵 𝗲𝗱𝗶𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗷𝗲𝗰𝘁 underway 𝗼𝗻𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗗𝗲𝘀𝗶𝗴𝗻 𝗦𝗽𝗲𝗰𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 – 𝗚𝗼𝗮𝗹 𝟲 of the 𝗔𝗿𝗰𝗵𝗶𝘁𝗲𝗰𝘁𝘂𝗿𝗲 𝗦𝗽𝗲𝗰𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻:

“Establish a policy relating requirements of the IEC 60601 series to the IMDRF essential principles and labelling principles.”
𝗚𝗼𝗮𝗹 𝟲 𝗶𝘀 𝗱𝗶𝗿𝗲𝗰𝘁𝗹𝘆 𝗿𝗲𝗹𝗮𝘁𝗲𝗱 𝘁𝗼 𝘁𝗵𝗲 𝗜𝗠𝗗𝗥𝗙 𝗱𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝘀 𝗡𝟰𝟳 𝗮𝗻𝗱 𝗡𝟱𝟮 𝘄𝗵𝗶𝗰𝗵 𝘄𝗲𝗿𝗲 𝗿𝗲𝗰𝗲𝗻𝘁𝗹𝘆 𝘂𝗽𝗱𝗮𝘁𝗲𝗱 𝘁𝗼 𝗘𝗱𝗶𝘁𝗶𝗼𝗻 𝟮.

The Architecture Spec states:

“It is the 𝗽𝗼𝗹𝗶𝗰𝘆 𝗼𝗳 𝗜𝗘𝗖/𝗧𝗖 𝟲𝟮 𝘁𝗼 𝗶𝗻𝗰𝗹𝘂𝗱𝗲 𝗮𝗻 𝗶𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝘃𝗲 𝗮𝗻𝗻𝗲𝘅 𝗺𝗮𝗽𝗽𝗶𝗻𝗴 the 𝗿𝗲𝗹𝗮𝘁𝗶𝗼𝗻𝘀𝗵𝗶𝗽 𝘁𝗼 𝘁𝗵𝗲 𝗜𝗠𝗗𝗥𝗙 𝗘𝗦𝗦𝗘𝗡𝗧𝗜𝗔𝗟 𝗣𝗥𝗜𝗡𝗖𝗜𝗣𝗟𝗘𝗦 𝗮𝗻𝗱 𝗟𝗔𝗕𝗘𝗟𝗟𝗜𝗡𝗚 𝗣𝗥𝗜𝗡𝗖𝗜𝗣𝗟𝗘𝗦 in 𝗲𝗮𝗰𝗵 𝗼𝗳 𝘁𝗵𝗲 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗼𝗳 𝘁𝗵𝗲 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 𝗦𝗘𝗥𝗜𝗘𝗦.”
This is a goal of IEC/TC 62.  For the IEC 60601-1, 4^th edition project all Working Groups (WG’s) are tasked to do this work in their WG’s.  There are 12 WG’s split up by hazards. In the future all standards that are developed by IEC/TC 62 should also follow this goal.
Another part of Goal 6 from the Architecture Spec states:
“The 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 𝗶𝗻 𝗺𝗮𝗻𝘆 𝗼𝗳 𝘁𝗵𝗲 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 𝗦𝗘𝗥𝗜𝗘𝗦 are 𝗶𝗻𝘁𝗲𝗻𝗱𝗲𝗱 𝘁𝗼 𝗳𝘂𝗹𝗳𝗶𝗹 𝘀𝗼𝗺𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗽𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲𝘀 set out 𝗶𝗻 𝘁𝗵𝗲 𝗜𝗠𝗗𝗥𝗙 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗱𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝘀. To facilitate the usage of the documents in the IEC 60601 SERIES for conformity assessment purposes by the AUTHORITIES HAVING JURISDICTION, it is important to 𝗰𝗹𝗲𝗮𝗿𝗹𝘆 𝗶𝗻𝗱𝗶𝗰𝗮𝘁𝗲 𝘄𝗵𝗶𝗰𝗵 𝗜𝗠𝗗𝗥𝗙 𝗽𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲𝘀 𝗮𝗿𝗲 𝗰𝗼𝘃𝗲𝗿𝗲𝗱 𝗯𝘆 𝘄𝗵𝗶𝗰𝗵 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 𝗶𝗻 𝗮 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱 𝗶𝗻 𝘁𝗵𝗲 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 𝗦𝗘𝗥𝗜𝗘𝗦.”
This 𝗚𝗼𝗮𝗹 𝟲 𝘀𝘂𝗽𝗽𝗼𝗿𝘁𝘀 𝘁𝗵𝗲 𝗜𝗠𝗗𝗥𝗙’𝘀 𝗰𝗼𝗻𝗰𝗲𝗽𝘁 𝗼𝗳 𝗲𝗹𝗶𝗺𝗶𝗻𝗮𝘁𝗶𝗻𝗴 𝗱𝗶𝗳𝗳𝗲𝗿𝗲𝗻𝗰𝗲𝘀 𝗯𝗲𝘁𝘄𝗲𝗲𝗻 𝗷𝘂𝗿𝗶𝘀𝗱𝗶𝗰𝘁𝗶𝗼𝗻𝘀 which 𝗱𝗲𝗰𝗿𝗲𝗮𝘀𝗲𝘀 𝘁𝗵𝗲 𝗰𝗼𝘀𝘁 𝗼𝗳 𝗴𝗮𝗶𝗻𝗶𝗻𝗴 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 from the various AUTHORITIES HAVING JURISDICTION (AHJ) and allows 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 𝗲𝗮𝗿𝗹𝗶𝗲𝗿 𝗮𝗰𝗰𝗲𝘀𝘀 𝘁𝗼 𝗻𝗲𝘄 𝘁𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝗶𝗲𝘀 𝗮𝗻𝗱 𝘁𝗿𝗲𝗮𝘁𝗺𝗲𝗻𝘁𝘀.  This is a positive impact on patients and also makes for an easier process for the manufacturers and for the AHJ’s, as well.

When IEC TC 62/SC 62A/WG 39 met in Arlington, VA on 1- 2 May 2024 this was brought up during the meeting, as this is an important issue that needs to be addressed during the IEC 60601-1, 4^th edition project. One aspect WG 39 is dealing with is “Information to be supplied by the manufacturer” (i.e. Labeling).  This is the IEC 60601-1, 4^th edition WG that I am a co-convener of. There are lots of changes happening in the standards and regulatory world around labeling and we are working hard to keep informed on all these changes that will impact this project. 𝗦𝘁𝗮𝘆 𝘁𝘂𝗻𝗲𝗱 𝗳𝗼𝗿 𝗺𝗼𝗿𝗲 𝘂𝗽𝗱𝗮𝘁𝗲𝘀

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; training to 3rd or 4th edition; 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.

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

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.

View all the articles I have written for InCompliance Magazine.

I hope you enjoy this article and if you have any questions please feel free to contact me at Leo at EisnerSafety dot com or schedule a call with me.

1 January 2019 is not far away and the 4th edition of the standard may have a significant impact on the design, testing and documentation of many medical devices that have not met this standard yet.  For the US (FDA), EU (CE Mark for Medical Devices), and Canada (Health Canada) this is the final transition date to meet this requirement.

When do we have to comply with IEC 60601-1-2 4^th edition?
The three countries/regions of the world (US, EU, & Canada) have synchronized the date of compliance to 1 January 2019.  This was not always the case as FDA modified their transition date several times before settling on this date.  Realize that most other countries are requiring 3rd edition and some are still back on 2nd edition of IEC 60601-1-2.  A brief summary by region is shown below:

USA – For new submissions to the FDA, compliance to the 4^th edition will be mandatory by January 1, 2019. The FDA now recognizes the 4^th edition and encourages manufactures to comply with the 4^th edition for new device submittals and this can be seen in the updated Final Guidance for Home Use Medical Devices that the FDA re-issued in November 24, 2014 and updated on August 8, 2016 to update the transition date of ANSI/AAMI/IEC 60601-1-2. During this transition period the FDA also will accept 3^rd edition of the standard as well up til December 31, 2018.

European Union – The Date of Withdrawal (DOW) which is the required compliance date of EN 60601-1-2:2014, is December 31, 2018.  The DOW date is the end of the grand fathering period for the previous version of the standard, EN 60601-1-2007 (third edition).  After that date, all devices including legacy devices sold to the EU must comply with the new standard.

Canada – In Health Canada’s List of Recognized Standards it states that until December 31, 2018 it will accept Declarations of Conformity to either 3rd or 4th edition of IEC 60601-1-2.  After which declarations of conformity to IEC 60601-1-2:2007 – Ed 3.0 will not be accepted.

Other Regions – The compliance dates are highly variable driven by other international standards and local regulations. For example, for a particular standard (Part 2 particular standards IEC 60601-2-XX or IEC/ISO 80601-2-XX) for a given device will most likely at this time reference IEC 60601-1-2, 4th edition if the country is using the most current IEC 60601-2-XX or IEC/ISO 80601-2-XX standard but otherwise may be referring to an older version of the IEC 60601-1-2.   Additionally, some countries will NOT accept the 4th edition at this time to further complicate this issue.

Please note that compliance dates of standards are driven by their national regulatory bodies (i.e. US = FDA, Canada = Health Canada, etc.) and are subject to change.

It is strongly recommended to comply with the requirements of IEC 60601-1-2 4^th edition for all new medical device designs going into the US, EU, and Canada.  You may still need to meet 3^rd edition, as well.  It really depends on what other countries you plan to sell too and your regulatory strategy.  We can help put a test plan and test strategy together to deal with testing to 3rd & 4th edition.

We have several EMC experts that can assist our clients with the transition to IEC 60601-1-2, 4^th edition as it is having a major impact on the design, testing and documentation required of most medical devices.  We are seeing signs of a new wave of projects related to IEC 60601-1-2, 4^th ed. and know that this edition will have a big impact on electrical medical devices.

The EMC services we can provide your medical device company are listed below, for your convenience, in addition to our other regulatory, product safety, engineering, and quality system consulting services.

EMC Services Available

• EMC Design – Review of PCB schematics & layouts, enclosure design, mechanical construction, internal and external cabling design, etc.
• Mitigations  – Problem analysis, prototype fixes, support design engineering on redesigns, EMC component vendor liaison, etc.
• EMC Witness Testing & Documentation – Perform testing oversight, generate test plans, review and generate test reports
  
• Risk Analysis – Work with the design and test teams to address Risk Management as required by IEC 60601-1-2 4^th edition
• EMC Standards – Guidance and interpretation of numerous EMC standards and regulations
• EMC Regulatory Engagement & Support – Provide support for FDA, FCC, Health Canada, KFDA, ANVISA, CE Mark and other agency approvals
• Medical Device EMC Labeling – Review accompanying documents for compliance to IEC/EN 60601-1-2 requirements
  
• Training – Training your staff on EMC design, testing, IEC 60601-1-2, 4^th edition, and differences between 3^rd and 4^th editions

Are you ready for these changes, do you have the bandwidth to deal with these changes?  We can help you with preparing for these changes and on your EMC regulatory strategy. Contact us at Leo at EisnerSafety dot com or call Leo at 503-245-6558 to arrange an EMC project to help support your medical electrical device EMC needs.