Impacts on IEC 60601-1, 4th Ed. – Webinar Recap and Industry Reactions

Insights from 110+ MedTech professionals on the upcoming 4th Edition and its impact on design controls, QMS, and labeling.

Video Replay Download Slides Schedule a Call

On August 15, 2025, I had the privilege of presenting the Impacts on IEC 60601-1, 4th Edition webinar as part of MLVx Friday In-Focus. The turnout was incredible, with more than 110 MedTech professionals from around the world joining. Startups, SMEs, large manufacturers, test labs, and regulators were all represented.

We unpacked the drivers and major changes in the upcoming 4th Edition, and the discussion didn’t stop when the webinar ended. Some of the most valuable insights came afterward in the LinkedIn conversations that followed.

See the replay post and comments here on LinkedIn
And the prior post: Major changes to IEC 60601-1, 4th Ed. are closer than you think

What the Industry Is Talking About

From the comments and follow-up conversations, four major themes stood out:

• SME vs Large Corp Burden – Smaller companies worry the 4th Edition requirements could hit them harder than large corporations with more resources.
• National & International Committee Involvement – Many are realizing that participating in standards development, even at the national level, gives manufacturers a seat at the table. Being involved internationally is even more powerful if you can swing it.
• Rationale Behind Requirements – The Design Specification requires a rationale for each requirement of the standard. This is not fully addressed in Ed. 3.2, so the change should help improve industry understanding of the standard going forward.
• Impacts on Design Controls, QMS, and Labeling – These changes are not just “paper exercises.” They will reshape how manufacturers approach design controls, QMS integration, and labeling processes across the entire product lifecycle.

Replay Video

If you missed the live session or want to revisit the details, here’s the full webinar replay:

Download the slides here

Why This Matters

As the IEC 601 Guy, I’ve been deeply involved in the development of IEC 60601-1, not just for this edition but also for the previous edition. The 4th Edition is shaping up to be one of the most impactful yet, especially in how it connects to design controls, supplier oversight, and QMS processes.

Conversations like these are important because they highlight the real-world concerns of manufacturers, regulators, and test labs. They help ensure implementation of the standard is proactive, not reactive.

How We Can Help

If your team needs help mapping these 4th Edition changes into your design controls, QMS, or testing strategy, my team at Eisner Safety Consultants and I are here to support you.

Schedule a call with me, Leo, the IEC 601 Guy. My team & I are here to support your needs.

Keep the Conversation Going

Standards only evolve when industry voices are active. I encourage you to:

• Join the LinkedIn conversation: Replay post + comments
• See the earlier discussion thread: Major changes to IEC 60601-1, 4th Ed. are closer than you think
• Explore more insights on my blog: Standards Updates or see my previous Podcasts

Together, we can make sure these changes lead to safer devices, smoother regulatory pathways, and stronger compliance strategies.

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.

ISO TC 210 WG2 met in Tokyo, Japan on 4 – 5 March 2025.

WG2 meeting focused primarily on resolving the National Committees (NCs) comments received on the ISO/DIS 20417, 2^nd ed.

• Thx to the hard work of our fearless Project Leader, doing a huge amount of prep work just prior to the WG meeting.
• WG was able to review and resolve all the comments.
• Next step will be to circulate for FDIS ballot ISO/FDIS 20417, 2^nd ed., that the NCs will vote on.

Changes proposed:

Add reference to transport and storage symbols for environmental conditions for packaging to distinguish between transport and storage environmental conditions.

• Updated sub-cl 6.5.3 a) new sub items 2) & 3) with symbols for transport and storage – Special Section not included in LinkedIn Post
• These symbols for transport is Symbol 3869 from ISO 14617-14:2004 (link goes to the ISO online browsing platform) and for storage is Symbol 2066 from ISO 14617-7:2002
• This has been something I have been developing for more than a year with TC 210/ WG3 and also IEC 60601-1, 4^th ed., IEC TC 62/SC 62A/WG38 with a small team. At the Tokyo meeting TC210 / WG3 we have set up a task team to look at the proposed symbols for transport, storage and operation (operation was not included in ISO 20417 as no comment was provided). WG3 task team has not met yet so unable to share the proposed symbols from WG3 perspective at this time.
  
  IEC TC 62/SC 62A/WG38, Fragment 2, (IEC 60601-1, 4th ed. – learn more about it) 62A/1630/CD was issued Dec 6 2024 and was closed for comments on Feb 28 2025. We are meeting in Arlington, Virginia at the AAMI offices to work on the comments March 30 – April 4, 2025. The two symbols above are part of the symbols that are in the CD and there are additional ones including one for operating IEC 60417‑6090:2012 and transient IEC 60417-5184:2002 environmental conditions, and indoor use IEC 60417-5957:2004. Some combination of the environmental conditions such as temperature, humdity, and atmospheric pressure will need to be combined as applicable to operation, storage and transport. Trainsient is a special condition. Please refer to the CD to understand the usage of the symbols.

Deleted 6.1.2 d) 1) (Change from “EC Rep” to “XX Rep”)

• Align with update of ISO 15223-1:2021/A1:2025 published March 3, 2025 with “EC Rep” changed to “XX Rep” (5.1.2).
• 6.1.2 d) 1) previously stated: “When using symbol 5.1.2 from ISO 15223-1:—, the ‘EC’ may be replaced by the 2-letter or 3-letter country code given in ISO 3166-1.”

 Added concept of “applicable policy”

• New 3.3 definition.
• Aligns with 1/2634/CDV of IEC 60050-880, 1^st ed, term 880-17-02) & about 20 additions in the normative text to “applicable policy” making those requirements based on what the authority having jurisdiction requires so more flexible.

Changed from “production control” to “production control identifier”

• Make clearer the definitions of lot number, lot code, batch code, batch number, serial number, & other options noted in 5.9 of ISO 20417, 1^st ed. (will be 5.8 ISO 20417, 2^nd ed.)

The requirements related to commercial product name were deleted as they were duplicative of the catalogue number requirements.

Deleted 4 b)

• The previous 4 b) roughly says: Normatively referenced edition of a standard in ISO 20417, ed., the manufacturer may substitute with a more current version provided by the manufacturer provided they can demonstrate the residual risk remains acceptable and is comparable to the residual risk that results from applying the normatively referenced document.
• The normative referenced standards in the new draft FDIS are undated or dated.  Undated references are required to be the most recent copy of the standard and the dated ones are required to be the dated version.  ISO 15223-1 is the only dated normative referenced standard and references ISO 15223-1:2021 and ISO 15223-1:2021/AMD 1:2025 (ISO format requirements) in the draft FDIS.

HAS Consultant comments received late, added to collated comments, and resolved. JTC3 will prepare updated Annex Zs for addition to the FDIS

updated the normative references

• Informative referenced standards (“should ” or “see standards” statement) were moved to the bibliography
• Dropped ISO 16142-1 & -2 standards as both were withdrawn

Delete former informative Annexes D, F, G and H;

• Annex D – Cross reference between the document and the requirements considered
• Annex F – Reference to the essential principles (ISO 16142-1:2016 & ISO 16142-2:2017 – both withdrawn)
• Annex G – Reference to the general safety and performance requirements for medical devices (Was previous corresponding list of GSPRs to the EU MDR list but will be replaced by Annex ZA^#)
• Annex H – Reference to the general safety and performance requirements for IVD medical devices (Was previous corresponding list of GSPRs to the EU IVDR list but will be replaced by Annex ZB^#)
• ^# Annex ZA & ZB The FDIS will include Annex ZA & ZB prepared by JTC3 but not the final ISO publication.

Need Help?

Need help with 60601 series standards including EMC? Eisner Safety Consultants can assist with strategic compliance planning for your medical electrical product lines, provide support when FDA or a regulator asks questions for a submission. We deal with EU, US, and other country regulatory requirements, standards, laws, directives, and guidances. Our team also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs, and more. We work with many test labs for medical safety, EMC and can arrange other testing, as well. Feel free to schedule a web meeting with Leo or contact us.

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Leo Eisner, founder of Eisner Safety Consultants and a leading voice in IEC 60601 standards development.

We unpack the upcoming revisions to IEC 60601, 4th ed., focusing on the rationale behind these changes, their impact on medical device design, and how MedTech professionals can prepare for the future.

Leo provides insights into the intricate process of updating global standards, shares practical advice for compliance, and discusses the role of risk management in ensuring safer, more effective medical devices.

Key Points:

1. New Modular Approach:
   • The updated standard adopts a modular approach (12 working groups focused on specific hazard areas).
   • Simplifies updates by consolidating Collateral Standards into the General Standard.
   • Aligns better with global regulations.
2. IEC 60601-1 4th Edition:
   • Focuses on addressing various hazards including:
     • physical environment,
     • electrical,
     • thermal and fire,
     • mechanical,
     • user interface (usability, alarms, information supplied by the manufacturer & user interface aspects),
     • materials,
     • optical radiation, and
     • electromagnetic exposure hazards.
3. New Requirements:
   • Introduces new international requirements for wireless coexistence and other cutting-edge technologies (e.g., gas pathways, user interface aspects).
4. Consolidation of Standards:
   • Collateral standards are being consolidated to improve consistency and reduce the update cycle time for the 60601 series.
5. Timeline and Publication Dates:
   • Expected timeline for the fourth edition is 2029-2030.
   • Companies need to plan now, though the actual timeline may slip depending on various factors.
6. Benefits of Proactive Planning:
   • Proactive planning and test preparation are essential for regulatory success.
   • Staying informed and embracing continuous learning in MedTech are key factors for success.
7. Practical Advice for Compliance:
   • Begin designing for new standards early, even before they are finalized. MedTech design cycles are long.
   • Engage with industry groups and standards organizations.
   • Use test planning to streamline development and meet regulatory expectations efficiently.
8. Engaging in the Standards Development Process:
   • Manufacturers are encouraged to engage in the standards development process and submit comments.
   • This proactive approach can help shape the standards and ensure they are practical and achievable.

These updates aim to enhance safety and performance while keeping pace with technological advancements. Manufacturers need to stay informed and prepare for the impact these changes will have on their product lines and quality systems.

Resources:

Design specification Outline for the fourth edition of IEC 60601-1

Architectural Specification For Safety Standards of Medical Electrical Equipment, Medical Electrical Systems, and Software Used in Healthcare

Only 5 of the 12 Fragments went out for CD on 6 Dec 2024, which were Working Groups (WGs) WG37, 38, 39, 40 & 47 (Fragments 1, 2, 3, 4, & 11 respectively). The status of each of these Fragments is noted below:

• Fragment 1 (WG37) Status
• Fragment 2 (WG38) Status
• Fragment 3 (WG39) Status
• Fragment 4 (WG40) Status
• Fragment 11 (WG47) Status

The other 7 fragments will go out for CD approximately May ’25 (estimated schedule is my best intelligence). Fragments 5 – 10 & 12. You can look at the SC 62A Work Programme and find the Fragment number in the descriptions for each project on the first 12 projects of the Work Programme to find the status of each Fragment.

If you are a National Committee (NC) member and want to comment on the Fragment depending on your NC rules you may be placing your comments directly into the Online Standards Development (OSD) Platform for the Fragment. Other NCs are collecting the comments and then the NC Secretariat (or similar role) will be responsible for placing all the comments into OSD. Please check with your NC for your specific rules. Details about the OSD platform, How to use OSD, OSD resources (various training and other resources)

New terms and definitions which IEC 60601-1, 4th Ed. will be based on but other Technical Committees will adopt across the Healthcare sector to increase consistency – “International Electrotechnical Vocabulary (IEV) – Part 880: Electrical equipment, electrical systems and software used in healthcare” – IEC Website that has the schedule, list of draft documents. The CDV was released on 13 Dec 2024. If you are a National Committee Member of TC 1, TC 62, SC 62A, SC 62B, SC 62C, SC 62D, TC 65, TC 66, TC 76, TC 87, or SyC AAL you should be able to get access to this document and be able to comment on this document. This document is also being distributed for comment to ISO TC 210 and some additional ISO TCs .

Engage with the Podcast on the LinkedIn Post we’d like to hear from you

If you found this interesting or helpful, consider reposting on LinkedIn; follow me, Leonard (Leo) Eisner, the60601Guy and click the so you don’t miss future content.

Need Help?

Need help with 60601 series standards including EMC? Eisner Safety Consultants can assist with strategic compliance planning for your medical electrical product lines, provide support when FDA or a regulator asks questions for a submission, and more. We deal with EU, US, and other country regulatory requirements, standards, laws, directives, and more. Our team also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs, and more. We work with many test labs for medical safety and EMC and can arrange other testing as well. Feel free to schedule a web meeting with Leo or contact us.

What’s on the menu?

Where are we headed with 4th Ed.?
Structure changes;
Project timeline: and
Critical documents

Leo Eisner, the “IEC 60601 Guy”, of Eisner Safety Consultants will be your guide

What to do in the meantime?
Select applicable and normative standards for testing; and
How to set up a solid future-proof test plan

Ian Sealey of Vertexian will explain it

When, Where, How:

7 October 2024

Clayton Hotel Chiswick
Arrive 5:00 PM
Starts 5:30 PM
Ends 8:45 PM

Networking and meet for drinks afterwards

Register by either using our Contact form or send Leo a LinkedIn message via his profile.

If you would like to meet with Leo during the week of 7 Oct in London please contact him to schedule this rare opportunity.

Presenters Background:

Leo is the founder and principal compliance and regulatory consultant of Eisner Safety Consultants (ESC), ESC provides the medical device industry (from SME’s to Fortune 500’s) with product safety compliance & regulatory support focused on:

• design for compliance to IEC 60601 series of standards;
• design reviews against applicable requirements;
• identification of applicable standards, laws, regulations, directives and guidances;
• labeling reviews;
• support with test labs;
• training

Leo’s leadership and commitment in the standards development process runs deep and over many years including his involvement in numerous IEC, ISO, and AAMI working groups, committees, and maintenance teams over the last 20 years. 
His IEC 60601-1, 4^th edition involvement:

• Co-Convener of IEC/TC 62/SC 62A/WG39 – User interface aspects
• Advisory group member of IEC/TC 62/SC 62A/AG 50 – IEC 60601-1 Ed. 4.0 editing & leadership team
• Committee member IEC/SC 62A/WG37 – General requirements

To see a more detailed list go to Leo’s LinkedIn Profile.

Ian Sealey is the founder of Vertexian and is a medical device regulatory and quality consultant, with over 25 years’ experience. Vertexian provides the medtech industry with support in the following areas:

• electromedical devices;
• risk management;
• pre-compliance testing;
• training;
• UKCA marking; and
• manufacture of IEC test equipment

He was Assistant Secretary to the Board of the Department of Health (DH), a Medical Device Specialist at the Medicines and Healthcare products Regulatory Agency (MHRA), and a principal Medical Engineer in the National Health Service (NHS). He is a director of a health-related charity and a visiting university lecturer.

Need help with 60601 series standards including EMC; strategic compliance 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. Eisner Safety Consultants team of experts also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs and more. He team includes experts on additional standards committees and we all talk to the regulators regularly. We’re here to support your needs.

We work with many test labs for Medical 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.

We are thrilled to announce three incredibly talented individuals joining the Eisner Safety Consultants Team to support your needs.

Beat Keller’s expertise comprises the IEC 60601 series, software, and regulatory/quality. In the regulatory/quality area, he focuses on EU MDR, Swiss MedDO, and UK MDR.

Lisa Donlon’s expertise encompasses device regulatory/submissions and quality. Her focus is on EU MDR, clinical Evaluation Assessment, and NB Remediation.

Dan Modi’s expertise spans the IEC 60601 Series, EMC, design quality, device submissions/regulatory – EU MDR, U.S., India, China, Brazil, Japan, and more.

We have strengthened our team to support your needs so please feel free to schedule a meeting to discuss your needs or contact us.

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.

2 February 2022 

On 1 February 2022  the Gov.UK website updated their Guidance on Using the UKNI Marking. It was originally published on 31 December 2020. This is guidance for placing goods on the Northern Ireland market.

The UKNI mark applies for Northern Ireland specifically.

Contents of the current UKNI Guidance is

1. Overview
2. Check whether you need to use the UKNI marking
3. When to use the UKNI marking
4. How to use the UKNI marking
5. Technical documentation
6. Webinars
7. More information

The Guidance document also points users of the Guidance to the other Marking of concern. It states “For similar obligations that apply when using other conformity markings, see how to use the UKCA marking.” This is for placing goods on the British (UK) market.

Another link in the Guidance that is critical if you need to place a medical product on the UK market is looking at the UK Market Conformity Assessment Bodies (UKMCAB) database. This db you want to make sure you find a Medical Device Assessment Body that covers your device. At first glance there now are a lot of bodies (157 currently) in the db but not all of them fall under medical devices. There are still only 3 of them and they are the usual suspects being BSI, UL and SGS. Best way to search is under the “Medical Device” under the Legislative Search details option.

Need Help?

Need help with the UK, EU MDR requirements, IEC 60601 (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.

Regulatory Update – January 2022 Index

I have 4 Regulatory updates (US (2), England, Scotland & Wales (1), EU 1)) for you that are full of great information. Below is a mini index so you can jump around the world as needed – Enjoy and let me hear your feedback on Linked for this post.

1. FDA Updates Recognized Consensus Standards db with List 057
2. FDA Guidance documents Issued – Final and Drafts Recently
3. EC Has Finally Set-Up a Harmonised Standards Website for MDR & IVDR
4. UK Designated Standards for Medical Devices, Active Implants, and IVDs published

FDA Updates Recognized Consensus Standards db with List 057

Read the Federal Register Notice for the modification of list 056 on 9 Dec 2021 to see specifically which standards were withdrawn (you can’t see that detail on the db as withdrawn standards are not shown on the db). The ones that are transitioned and the transition periods are noted but only for the transition period so it is always good to review the Federal Register Notices to understand the full picture in my humble opinion.

Download the table with the list 057 Recognized Consensus Standards for the full list of standards that were updated on this latest update.

Or you can go to the FDA’s Recognized Standards db and search for 12/20/2021 to 12/20/2021 Publication date range to see the 90 standards that are part of the List 057 updates (some are just version changes, some are new standards – See the Federal Register Notice above)

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FDA Guidance documents Issued – Final and Drafts Recently

FDA has been busy with Draft & Final Guidance documents in the last 90 days. I put together a document of some of the more relevant Guidance documents for the medical device industry over the last 90 days. This download includes a Comment column that is a summary of the Guidance (FDA & sometimes my comments added). If the Guidance is a draft I provide the comment link if you would like to send in a comment to the FDA (public or anonymous can be posted), of course the link for the guidance, and more. The Guidances are: 1) Combination Devices (Final), 2) Patient-Reported Outcome Instruments for Use in Medical Device Evaluation, 3) Patient Engagement in the Design and Conduct of Medical Device Clinical Studies, 4) Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions, 5) Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology, 6) Referencing the Definition of “Device” in the Federal FD&CA in Guidance… 7) Content of Premarket Submissions for Device Software Functions.

Download the

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EC Has Finally Set-Up a Harmonised Standards Website for MDR & IVDR

The European Commission overhauled the sectoral website on Medical Devices in now accessible from the DG SANTE’s Public Health website – a new specific webpage on Harmonized Standards has been set up from the web page “Medical Devices – Topics of Interest”, which has some great topics of interest including Notified Bodies (You can find the NBs for both the MDR & IVDR, the codes they are designated under & more info), UDI (Bountiful resource page), Reprocessing (Well worth reading to understand where the European Commission and each country stands on this issue currently), Latest Updates (separate web page), and more. The Harmonisation web page contains the links to the standardization requests in force and to the publications in the OJEU of references of harmonized standards conferring a presumption of conformity in support of the MDR & the IVDR. The page will gradually grow with more publications, and also with future amendments to the standardization request.

For the latest lists of the MDR & IVDR Harmonized Standards please go to my previous post. Most likely the next update likely to occur March /April 2022.

The above information is thx to Mario Garbielli Cossellu a Policy & Legal Officer at the European Commission provides many great updates on the MDR & IVDR. Check out his recent posts there is always some great content to keep up to date on. I’ve been following him for years on LinkedIn.

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UK Designated Standards for Medical Devices, Active Implants, and IVDs published

The general Designated Standards website covers all categories of products, services or processes to comply with essential requirements of the applicable legislation.

Within that web page there is information on the designation process, reference of designated standards, and then the different industries, product, and processes. Within that list there is a Healthcare engineering section.

The 3 important lists are all controlled by the MHRA. They are:

1. Medical Devices
2. In Vitro Diagnostic Medical Devices
3. Active Implantable Medical Devices

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Need Help?

Need help with the UK, EU MDR requirements, IEC 60601 (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.