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

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 me, Leonard (Leo) Eisner, the “IEC 60601 Guy”,

in a conversation with Subhi Saadeh of Combinate Podcast

as we look at how to assess applicable standards for medical and combination devices and a few highlights on IEC 60601-1, 4th ed. in Combinate Podcast 148 https://bit.ly/LIPostCombinatePodcast148LeoEisner

He really does his research and is a great interviewer. I always find it fun and intriguing to have a conversation with Subhi as I too learn from our conversations.

We discuss:
☞ complexities in assessing applicable standards
☞ understanding the impact of product environment, intended use, & applicable markets
☞ challenges and strategies for documenting standards assessments
☞ leveraging existing standards to avoid unnecessary development
☞ tips for small and large companies
☞ significance of early research
☞ essential stakeholders involved in standards assessment
☞ and more….

Join us in the conversation on LinkedIn and leave your comments so we can continue this discussion.

Need help with 60601 series standards (Medical Electrical Equipment) 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. 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 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.

 My conversation with Subhi Saadeh of Combinate Podcast was very intriguing and he does a fun podcast. Check out the podcast as I talk about Standards.

We covered a lot of ground in a short time (it flew by for me – I’m sure it will for you too) and if you compare him to an architect he would build something similar to the Louvre Museum with its very unique but beautiful peaks and valleys with surprises around every corner. The Lourve is recent in my mind as I was at an ISO TC 210 standards meeting in Paris Dec ’23 and visited the Louvre. One of my many travels around the world in support of standards development over the last 20 years.

He really does his research. He found my old reconnaissance standards database I was planning to publish but never did. That was a total surprise.

We dive right into standards in many ways that you may not have thought of before in Podcast :
☞ The explosion of standards vs no standards (or chaos of no standards)
☞ The impact of standards on medical device development
☞ Standards and Regulatory Challenges
☞ My Notified Body Auditing Experience, Authorization Process, Product Reviewer
☞ The Challenges of Maintaining and Updating Standards

Need help with 60601 series standards (Medical Electrical Equipment) 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. 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 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.

On December 20, 2021 the FDA Released their Recognition List Number 057 through their online db. With that publication of list 057 two, EMC IVD standards were added to the list.
But the FDA only Partially Recognized IEC 61326-1:2020 and IEC 61326-2-6:2020.
What does that mean to IVD EMC tests?
We have done a detailed analysis that has been confirmed by FDA’s EMC experts to let you know what EMC tests you need to conduct in order to meet both FDA and EU requirements for IVD equipment.

If you have IVD devices that you are submitting to the FDA you will need to be aware of these requirements. Rely on our experts for this analysis. We have had discussions with the FDA to understand the issues so we can explain this information.

Click here to link to the order page.

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.