This post assumes you already know that EN 60601-1:2006/A13:2024 landed at entry No. 65 and that A13 carries Annex ZZ. From here I want to answer the questions my readers actually asked. I have deliberately not repeated much of what is already in the LinkedIn article, which covers the background, the full decision, and several points I do not revisit here, so it is worth reading alongside this.

The nine-year road from the MDR to entry 65.

Resources for this post

• Download the one-page cheat-sheet (PDF)
• Read the LinkedIn article
• See the LinkedIn launch post & comments
• Join the newsletter
• Schedule a call with Leo, “the IEC 60601 Guy”

What a presumption of conformity really buys you

Here is the sentence people skip: a harmonised standard gives you a presumption of conformity only for the requirements Annex ZZ says it covers. Not the whole of Annex I. Not “the device is compliant.” Just the specific General Safety and Performance Requirements (GSPRs) the table maps.

Annex ZZ is formally informative. It was prepared under mandate M/575 as one voluntary means of conforming, and it spells out the mechanism: once the standard is cited in the Official Journal, compliance with the normative clauses in its Table ZZ.1 confers a presumption of conformity, but only within the scope of the standard.

Look at Table ZZ.1 itself, the mapping table inside Annex ZZ, and its limits jump out. In its “Remarks / Notes” column, coverage is stated again and again as basic safety and essential performance within the scope of the EN, not the whole of a requirement. Whole categories come back “not covered” or only “partly covered,” because 60601-1 addresses them only by pointing to other standards: biocompatibility, EMC, usability, and sterilization all fall into that bucket. The standard says so in its own notes: if a GSPR is not in Table ZZ.1, it is not addressed here.

Annex ZZ also carries Table ZZ.2, the terms where the MDR definition prevails over the standard’s. “Harm” in the standard reaches property and the environment; under the MDR it narrows to people. “Patient” means human use only under the MDR, whereas in the EN it has always included animals and will continue to do so in the 4th edition. “Risk management” as the MDR uses it is broader, so the standard’s coverage of it is correspondingly limited. A reviewer reads your file against the regulation’s vocabulary, not the standard’s.

So the real work is not “we cite the harmonised standard, therefore we are covered.” Run it as a gap analysis: lay every Annex I GSPR as a row; for each one Annex ZZ maps, record the clause and copy any partial-coverage qualifier word for word; for the GSPRs 60601-1 does not touch (biocompatibility, EMC, sterilization, much of usability, clinical, labelling content), name the other standard, test, or risk-file evidence that carries it; and flag anything leaning on an older or non-harmonised source before a reviewer does.

Two Z-annexes, two different jobs: do not confuse ZA with ZZ

While everyone talks about Annex ZZ, do not walk past Annex ZA. They look alike and do completely different things.

Annex ZZ (informative by designation, but the mechanism the Official Journal citation activates) maps the standard’s clauses to the MDR GSPRs and supports the presumption of conformity. Annex ZA is the normative references table: it lists every IEC and ISO publication the standard depends on and gives the corresponding European (EN/HD) version. Being normative, those references are part of the requirements.

Annex ZA carries two rules that quietly decide what you must meet. First, dated versus undated references: for a dated reference only the cited edition applies; for an undated one the latest edition, including amendments, applies, so it moves under your feet over time. Second, “(mod)” means the international text was changed by European common modifications and the EN/HD applies, not the plain IEC or ISO version.

The Z-annexes for the EN 60601 and EN 80601 series standards are drafted by CENELEC, in TC 62 WG 2 for medical devices. The members of that committee have written a guide titled the “Cookbook” for writing harmonised standards under the MDR and IVDR. Beat Keller, one of my ESC experts, is a member of that committee. The cookbook exists to give the writers of these harmonised European standards practical, consistent ways to handle the European forewords and the Z-annexes, and in particular to resolve the issues raised during HAS consultant assessments of draft standards. It is not a minor internal note either: the European Commission’s DG SANTE and the MDCG standards subgroup judged its first edition “in principle complete and ready for use” back in November 2022, which made it a solid basis for writing the harmonised standards in this series and their annexes.

“Harmonised” is not the same as “state of the art”

One of the sharpest points from the comments is worth making loudly: presumption of conformity and state of the art are two different tests, and passing one does not pass the other.

A harmonised standard, applied in scope, gives presumption of conformity for the GSPRs it covers. State of the art is a separate expectation running through the MDR’s GSPRs in Annex I, and it is not defined in the regulation. In practice the newest recognised edition is treated as the state of the art, even when that edition is not the harmonised one. So the version that gives you the presumption can be older than the version that represents the state of the art, and when they diverge you can be presumed conformant and still be expected to show how you meet the current state of the art.

A concrete example sits inside this very decision. Before 17 June 2026, citing the older EN ISO 10993-23:2021 held a valid presumption, yet its 2025 amendment was already the newer state of the art. The same Decision (EU) 2026/1231 then harmonised the amended versions and set the old ones to be withdrawn from 15 December 2027. That lag is the normal rhythm, not a glitch: when a newer edition appears, assess it as potential state of the art even while you still cite the harmonised version for presumption.

And the citation question that came up in the comments now has a clear answer. For use under the MDR, cite the full amendment chain: EN 60601-1:2006+A1:2013+A12:2014+A2:2021+A13:2024, which corresponds to IEC 60601-1:2005+A1:2012+A2:2020 (Edition 3.2, with A13:2024 carrying Annex ZZ). That is how the standard designates itself on its own cover, and it is what belongs on your Declaration of Conformity and standards list. The clipped “EN 60601-1:2006/A13:2024” is fine for a headline, not for your technical documentation.

Legacy devices and the audit question

Now that 60601-1 is harmonised, will Notified Bodies scrutinise how legacy data lines up with it? First the framework. Legacy devices on valid MDD or AIMDD certificates under Article 120(3) of the MDR, as amended by Regulation (EU) 2023/607, may stay on the market to the 2027 or 2028 dates provided they keep conforming to their directive and undergo no significant change (MDCG 2020-3). They are not required to re-certify to a harmonised 60601-1. What continues to apply are the ongoing MDR obligations, including post-market surveillance, vigilance, and risk management.

So the new listing does not, by itself, force anything onto a legacy device. But once a current harmonised reference exists, it becomes the obvious yardstick, and reviewers reach for the obvious yardstick. For devices in MDR conformity assessment now, EN 60601-1:2006/A13:2024 is the reference to build against; for legacy devices, expect questions less about re-certifying and more about whether your risk management and post-market data still hold up against the current state of the art. Depending on what your risk management and any gap assessment turn up, that can, in some cases, push you toward a more current version of the standard.

The scope trap: your medical device might also be “machinery”

Here is one that quietly catches manufacturers, buried in the same Annex ZZ. Under Article 1(12) of the MDR, a medical device can also be machinery within the meaning of the EU Machinery Directive (2006/42/EC). When it is, certain Essential Health and Safety Requirements of that directive that are more specific than the MDR GSPRs apply on top of the MDR, and the standard maps them in Table ZZ.3.

In practice this bites devices with lifting parts or accessible non-manual moving parts: patient hoists, powered tables and chairs, motorised carriers. Two things people get wrong. First, Table ZZ.3 does not give you a presumption of conformity under the Machinery Directive and implies no Official Journal citation under it; it only maps where the machinery requirements are more specific. Second, the Machinery Directive is on its way out: Regulation (EU) 2023/1230 replaces it from 20 January 2027, so plan against the new Machinery Regulation, not the old Directive.

This is one of the most commonly missed corners of 60601-1 compliance, and untangling it is exactly the kind of scope work my team does. If your device lifts, rolls, or has powered moving parts an operator can reach, do not assume the MDR is the whole story.

Why “EC REP” existed in the first place

“EC” stands for European Community, the correct legal name until the Treaty of Lisbon replaced it with “European Union” in December 2009. So the “EC” in “EC REP” has been out of step with the Union’s own vocabulary for more than fifteen years. That is the whole reason for the move to “EU REP,” and it is why MDCG 2021-5 Rev. 1 can call it “purely editorial.” The generic symbol itself comes from EN ISO 15223-1: the standard defines an “XX REP” where “XX” is the ISO 3166-1 country code, and the Commission worked with the ISO working group to land on “EU” for the Union. The change did not appear from nowhere. It began as Amendment 2 to standardisation request M/575 (Commission decision C(2024)3371) in May 2024, when the Commission asked CEN and CENELEC to introduce “EU REP” and drop any reference to “European Community.” CEN and CENELEC accepted, ISO adopted the amendment, the EN amendment followed, and the reference was published in the Official Journal on 17 June 2026, harmonised under both the MDR (Decision (EU) 2026/1231) and the IVDR (Decision (EU) 2026/1313). So this is not a rename someone slipped in; it is a deliberate, traceable alignment of the symbol with the Union’s own legal language.

The change is editorial. The change control around it is not free.

The symbol change needs no prior Notified Body approval on its own, and you have five years of coexistence. All true. But “no approval needed” is not “free.” Labelling changes cost money and time no matter how small the wording, so most manufacturers batch the swap into the next artwork refresh. That is where the “editorial” framing bites: the moment you bundle EU REP with any change that is not editorial, you can pull the whole batch into Notified Body territory. Treat the five-year window as planning room, look at everything else riding in the cycle, and use the same pass to retire other “European Community” era wording, including any lingering “EC Declaration of Conformity.” It also helps to know how much room the MDCG actually gives you. During the five-year window both symbols are valid, and you may even carry “EC REP” and “EU REP” on different levels of the same packaging, with re-labelling or over-labelling accepted, as long as the authorised-representative information stays clear. Devices already on the market with “EC REP” before the deadline can continue to be made available. One date to put in your plan: the MDCG appendix and the IVDR decision give the end date as 17 June 2031, but the binding MDR text (Article 2 of Decision (EU) 2026/1231) deletes the old reference from 15 June 2031, two days earlier, so cite the binding date in your technical documentation.

The signal I care about most

Look past the individual entries and there is a bigger story. The harmonisation route for medical electrical standards had been stuck for years, and this decision is evidence that it is moving again. For those of us working on the IEC 60601-1, 4th edition, and the future of the series, that matters more than any single listing: a new edition is only as useful as its route to recognition. Entry 65 is one line in the Official Journal, but it tells me the door is open again.

The bottom line

Entry 65 was the easy part. The harder, more useful work is downstream: reading Annex ZZ for what it actually covers, holding presumption of conformity and state of the art as two separate tests, keeping legacy devices honest against a sharper yardstick, catching the machinery scope trap, and treating the “editorial” label change as a change-control decision. None of that fits in a post. That is why it lives here. And because this piece deliberately does not rehash the LinkedIn article, go back to it for the full decision and the details I did not repeat here.

Download the one-page cheat-sheet (PDF): entry 65, what to cite now, the EU REP dates, and official EU sources in one place.

Turn this into practical action

My team and I at Eisner Safety Consultants work with medical device, IVD, and combination product manufacturers to turn standards into practical design inputs, GSPR and gap analysis, labelling, test strategy, and technical documentation. That includes the machinery-scope questions many teams miss, and it is the kind of work we do every day. If any of this maps onto what your team is wrestling with, I would be glad to talk it through.

• Schedule a call with Leo, the IEC 60601 Guy
• Join the ESC newsletter

About Eisner Safety Consultants

Led by Leo Eisner, “The IEC 60601 Guy,” Eisner Safety Consultants helps medtech, IVD, and combination product companies design for and demonstrate compliance to the IEC 60601 and IEC 61010 series and, for drug-device combination products, ISO 11608 needle-based injection systems. We support design reviews, identification of applicable standards and regulations, GSPR and gap analysis, labelling reviews, and test-lab and regulatory strategy. See more about our team of experts at eisnersafety.com.

Keep the conversation going on LinkedIn

• Read the full LinkedIn article: EN 60601-1 finally harmonised, and EN ISO 15223-1 ushers in “EU REP”.
• See the LinkedIn launch post & comments: “Entry 65: The Last Line,” the announcement that kicked this off.

Reference materials (official EU sources)

• Commission Implementing Decision (EU) 2026/1231 (MDR)
• Commission Implementing Decision (EU) 2026/1313 (IVDR)
• Regulation (EU) 2017/745 (MDR), Article 8, Annex I, Article 120(3)
• Regulation (EU) 2023/607 (Article 120 transitional periods)
• Regulation (EU) 2023/1230 on machinery (replaces Directive 2006/42/EC from 20 Jan 2027)
• MDCG 2020-3 Rev. 1: significant changes under Article 120
• MDCG 2021-5 Rev. 1 Appendix: transition to the ‘EU REP’ symbol

Key themes: IEC 60601/80601, IEC 61326-2-6, ISO 15223-1 A1:25, & ASCA considerations

In late December 2025, the FDA expanded its Recognized Consensus Standards Database, adding more than 100 new or updated standards. Some are eligible for use under the ASCA Program, while others carry important implications for design, testing, labeling, and overall regulatory strategy.

Regulatory expectations around standards are shifting earlier in the product lifecycle. Standards are no longer something teams can simply “handle at test.” Reviewers increasingly expect standards interpretation, risk decisions, and test strategies to be visible and justified during design reviews and technical documentation development. This reinforces why understanding not just which standards are recognized, but how they are recognized and applied, matters more than ever.

What the latest FDA update included

The scope of this database expansion spans a wide range of medical device technologies, including medical electrical equipment, IVDs, software-driven devices, imaging systems, interoperability standards, and labeling-related standards.

Beyond simply identifying newly recognized standards, the changes highlight how recognition status, ASCA eligibility, and extent of recognition can materially affect how conformity is demonstrated, how evidence is presented, and how submissions are reviewed.

Over the past year, I’ve been sharing what I’m seeing based on feedback gathered from many sources, including my Eisner Safety Consultants experts and discussions across the community with regulators, standards developers, test labs, and manufacturers. The goal is practical clarity: what changed, what it means, and what teams should do next as they navigate evolving standards expectations and regulatory requirements.

IEC 60601 / 80601 standards in the update

For manufacturers of medical electrical equipment, the December 22, 2025 update includes several standards from the IEC 60601 and 80601 series. These standards remain central to demonstrating basic safety and essential performance for medical electrical equipment. However, recognition alone does not mean every clause or requirement is fully accepted without qualification.

Standards called out in the December 22, 2025 update
(from the FDA database extract)

EMC context within the IEC 60601 / 80601 framework

IEC 60601-1-2 remains the primary EMC standard within the IEC 60601 series. However, other IEC 60601 standards can and do include EMC-related requirements. Applicability must be assessed standard by standard, based on the specific requirements of each applicable document.

This context becomes especially important when considering how EMC expectations are addressed across different standard families, including IVD-specific EMC requirements discussed next.

IVD EMC and IEC 61326-2-6

A notable change reflected in the FDA Recognized Consensus Standards Database is the inclusion of IEC 61326-2-6 Edition 4 as a Recognized Consensus Standard, with ASCA eligibility under the ASCA Program, effective July 28, 2025.

This is significant because IEC 61326-2-6 is the primary EMC standard used to demonstrate electromagnetic compatibility for IVD medical equipment, and its inclusion under ASCA directly affects how EMC conformity evidence may be presented in FDA submissions.

However, ASCA eligibility alone does not guarantee streamlined review.

For manufacturers intending to rely on ASCA pathways for IVD EMC:

• Test lab scope must be verified as active for the specific standards and applicable editions being claimed.
• If a standard or edition is not within a laboratory’s ASCA-accredited scope, manufacturers cannot rely on an ASCA Summary Test Report for that standard.
  • In those cases, full EMC test reports remain necessary, and FDA review timelines are typically longer.

As of early January 2026, there are no ASCA-accredited laboratories that reflect IEC 61326-2-6 Edition 4 within their active scope. This creates a practical timing and planning consideration for manufacturers preparing IVD submissions that intend to leverage ASCA.

This gap does not change the applicability of IEC 61326-2-6 itself, but it does affect how conformity evidence can be packaged and reviewed until laboratory scopes are updated.

ISO 15223-1 Amendment 1:2025 and labeling implications

Authorized Representative symbol changes and labeling impact

ISO 15223-1 Amendment 1:2025 introduces a substantive correction to the requirements for the Authorized Representative symbol that has direct regulatory and labeling implications across multiple markets.

This change is implemented through a revision to Clause 5.1.2, which governs how the Authorized Representative symbol is applied.

Clause 5.1.2 – prior to Amendment 1:2025

“This symbol shall be accompanied by the name and address of the authorized representative, adjacent to the symbol.”

Under this wording:

• The symbol itself did not explicitly encode the jurisdiction
• The convention of using “EC REP” persisted in practice, even after the transition from the MDD & IVDD to EU MDR and IVDR
• This created ambiguity for non-EU markets and for products marketed globally under different regulatory frameworks

Clause 5.1.2 – after Amendment 1:2025

“The [XX] text of the symbol shall be replaced by either the two-letter country code or the three-letter country code defined in ISO 3166-1 or other text required by the authority having jurisdiction.

This symbol shall be accompanied by the name and address of the authorized representative adjacent to the symbol.”

Key changes introduced by this amendment:

• The Authorized Representative symbol must identify the jurisdiction represented
• The jurisdiction identifier is no longer implicit or assumed
• Country-specific representation is now explicitly required using ISO 3166-1 codes or authority-mandated text

This change aligns the symbol requirements with:

• EU MDR and IVDR expectations for EU Countries
• Non-EU regulatory frameworks that require local authorized representation
• Global labeling clarity for multi-market products

Practical application of the revised requirement

International example

Used for countries outside the EU, such as Switzerland or the United Kingdom.

Examples:

• CH REP for Switzerland
• UK REP for the United Kingdom

Convert from EC Rep to International two-letter country code Authorized Representative Symbol

EU example

Used for EU Member States.

Convert from EC Rep to EU Rep Authorized Representative Symbol

Labeling and change-control implications

Symbol changes cascade into artwork, IFUs, packaging, and labeling change control. This affects and has significant impact on:

• Device labels
• IFUs
• Packaging artwork
• Labeling control procedures

These changes must be assessed and implemented through formal labeling change processes, not treated as isolated graphic updates.

Once the 4th Edition is published, redesigns and QMS updates will be far more costly.

Direct insights from someone in the development of IEC 60601-1, 4th Edition

Get an insider’s view of the upcoming changes, their real-world impact, and how to prepare, from someone directly involved in developing the standard.

Event Recap – MLVx Friday In-Focus

On Friday, August 15, the MLVx Friday In-Focus with Sean Smith brought together Leonard (Leo) Eisner, The IEC 60601 Guy, and 110+ professionals from around the globe, including the UK, Romania, US, France, Switzerland, Germany, Finland, and Pakistan, representing medtech manufacturers, regulators, test houses, and standards developers.

We focused on the impact of IEC 60601-1, 4th Edition, the global standard that defines safety and essential performance for medical electrical equipment, and what’s coming that many companies are still not prepared for.

The highlight was an impromptu expert panel with leaders in risk management, software, cybersecurity, regulatory submissions, and combination devices. Together, we tackled questions from every angle, sharing real-world insights on design, testing, and compliance challenges. The discussion showed exactly what’s possible when top experts collaborate to help the industry prepare for disruptive change.

(Full presentation available for download at the bottom of this post.)

Unlock Your IEC 60601-1 Insider Advantage

• Mitigate Risks: Spot disruptive changes early, prevent costly redesigns, and align documentation ahead of competitors
• Accelerated Compliance: Seamlessly integrate evolving requirements into your development pipeline
• Leadership Insight: The IEC 60601 Guy and our expert team track areas of interest for your organization based on draft documents
• Behind Closed Doors: Access knowledge while it’s still being developed
• Ready to Leap Ahead? Let’s turn this insider pipeline into your 4th Edition fast-track

+1-503-709-8328
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Schedule a Free 30-Minute Web Meeting

If you missed the live session, this recap and presentation will help you understand what’s coming — and more importantly, how to prepare.

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.

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

Leo Eisner, The60601Guy will be visiting London in October. You have the chance to sit down with me, The60601Guy, have a cup a coffee or a beer and talk IEC60601, design for compliance, and standards that apply to your device. I have time slots open on 7, 8, and 11 of Oct. Or join me for a dinner on the 8 or 11 Oct.

Meet me in London – I want to hear from you the week of 7 Oct. These two hour slots are limited before they are gone, 𝗯𝗼𝗼𝗸 𝗻𝗼𝘄 𝗼𝗻 𝗺𝘆 𝘀𝗽𝗲𝗰𝗶𝗮𝗹 𝗰𝗮𝗹𝗲𝗻𝗱𝗮𝗿 for 𝗺𝘆 𝗟𝗼𝗻𝗱𝗼𝗻 𝘃𝗶𝘀𝗶𝘁. I’d love to chat!

Let’s connect, and explore how we can support your company with our international team of compliance & regulatory experts from Eisner Safety Consultants. I’m eager to learn what you’re working on and how you’re driving change and innovation in the industry, and how we can support you to get you to market faster.

Let’s meet up! 𝗕𝗼𝗼𝗸 𝘁𝗶𝗺𝗲 𝗼𝗻 𝗺𝘆 𝘀𝗽𝗲𝗰𝗶𝗮𝗹 𝗰𝗮𝗹𝗲𝗻𝗱𝗮𝗿 for 𝗺𝘆 𝗟𝗼𝗻𝗱𝗼𝗻 𝘃𝗶𝘀𝗶𝘁.

Free presentation in London — With Leo Eisner, The60601Guy, & Ian Sealey

𝗪𝗵𝗮𝘁’𝘀 𝗼𝗻 𝘁𝗵𝗲 𝗺𝗲𝗻𝘂?

• Some 𝗳𝘂𝘁𝘂𝗿𝗲 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 of IEC60601-1 , 4th being considered you 𝙢𝙖𝙮 𝙣𝙤𝙩 𝙚𝙭𝙥𝙚𝙘𝙩:
Gas Pathways,
Cleaning,
Disinfection,
AI/ML,
Voice Input/Output,
Adhesives for Applied Parts,
PPE,
and so much more….

• IEC60601-1 , 4th Ed.
• Applicable Standards
• Future Proofing Test Plans

IEC 60601-1, 4th edition is currently in development and there are some SIGNIFICANT changes underway.

Ian Sealey, Michael Kipping, James Pink and I, Leonard (Leo) Eisner, The60601Guy, will be discussing the changes, indicative timescales, and how to plan for them.

𝗪𝗵𝗲𝗻, 𝘄𝗵𝗲𝗿𝗲, 𝗵𝗼𝘄:
7 𝘖𝘤𝘵𝘰𝘣𝘦𝘳 2024
𝘊𝘭𝘢𝘺𝘵𝘰𝘯 𝘏𝘰𝘵𝘦𝘭 𝘊𝘩𝘪𝘴𝘸𝘪𝘤𝘬
𝘈𝘳𝘳𝘪𝘷𝘢𝘭 𝘧𝘳𝘰𝘮 𝟱:𝟬𝟬𝙥𝙢
𝘚𝘵𝘢𝘳𝘵 𝟱:𝟯𝟬𝙥𝙢
𝘌𝘯𝘥 𝟴:𝟰𝟱𝙥𝙢
𝙉𝙚𝙩𝙬𝙤𝙧𝙠𝙞𝙣𝙜 𝙖𝙣𝙙 𝙙𝙧𝙞𝙣𝙠𝙨 afterwards

TICK TOCK – Time is starting to run out for signing up for this event. If you wait too long there won’t be room so sign up now before we fill up. Don’t wait tooooooo long and miss this great opportunity to learn from experts.

Register by using our Contact form, send Leo an email (go to bottom of page) or send Leo a LinkedIn message via his profile.

Join the conversation on the LinkedIn Post and leave a comment.

𝗪𝗵𝗮𝘁 𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗔𝗽𝗽𝗹𝘆 𝘁𝗼 𝗠𝘆 𝗗𝗲𝘃𝗶𝗰𝗲? Podcast with one of the best MedTech podcasters Etienne Nichols – Greenlight Guru‘s very own

𝗞𝗲𝘆 𝗧𝗼𝗽𝗶𝗰𝘀:
• Why standards like IEC60601 are crucial for medical device development
• Steps for identifying proper standards for your product
• How to integrate standards into your design process
• Mistakes & consequences of ignoring standards
• Tools for staying updated on changing standards & regulations
• How startups can navigate standards with limited resources

If you have any thoughts and comments on the podcast I’d would like to hear from you Comment on the LinkedIn post about the Podcast

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 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. His 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 web meeting with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.