MDD – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Wed, 01 Jul 2026 10:55:15 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png MDD – Eisner Safety Consultants https://eisnersafety.com 32 32 EN 60601-1 Harmonised, and “EC REP” Becomes “EU REP”: Annex ZZ, State of the Art, and the MDR Questions the Headlines Skipped https://eisnersafety.com/2026/06/30/en-60601-1-harmonised-and-ec-rep-becomes-eu-rep-annex-zz-state-of-the-art-and-the-mdr-questions-the-headlines-skipped/?utm_source=rss&utm_medium=rss&utm_campaign=en-60601-1-harmonised-and-ec-rep-becomes-eu-rep-annex-zz-state-of-the-art-and-the-mdr-questions-the-headlines-skipped Tue, 30 Jun 2026 22:50:00 +0000 https://eisnersafety.com/?p=8542 After the Official Journal harmonised EN 60601-1 on 17 June 2026, I later wrote up an overview: what changed, the nine-year wait, what to cite, and the EC REP to EU REP switch riding alongside it. Then the comments started, and the good ones went straight past the headline. This is the deeper cut.

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.

Timeline: nine years from the MDR to harmonisation of EN 60601-1
The nine-year road from the MDR to entry 65.

Resources for this post

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.

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

Reference materials (official EU sources)

]]> From Engineer To “The IEC 60601 Guy” – Project MedTech Podcast https://eisnersafety.com/2025/10/19/from-engineer-to-the-iec-60601-guy-project-medtech-podcast/?utm_source=rss&utm_medium=rss&utm_campaign=from-engineer-to-the-iec-60601-guy-project-medtech-podcast Sun, 19 Oct 2025 00:04:30 +0000 https://eisnersafety.com/?p=8354
Podcast Feature

From engineer to “The IEC 60601 Guy” — my story and practical tips

I joined Duane Mancini on the Project Medtech Podcast to share how I became known for IEC 60601, why the series is a roadmap you can follow, and what 4th Edition changes mean for design, QMS, and documentation.

Episode 235

Project Medtech Podcast Episode 235 – Leo Eisner
Listen on Web Open Spotify

A quick personal note

Nobody starts at the top as “The IEC 60601 Guy.” My path ran through early days at NASA, many years in test labs, and deep work in standards committees. What stuck with me is simple — stay curious, do the work, and show the work. That’s how we turn a dense standard into a practical plan.

Key takeaways from the episode

On the Project Medtech Podcast with Duane Mancini, M. Sc., I shared my genesis story of how I became known as The “IEC 60601 Guy”. Duane asked me to give listeners a 101 course on the IEC 60601 series, and I explained how I strive to “de-Greek” or demystify the standard series, and gave a preview of the big shifts coming in 4th Edition.

The “big picture” structure of the general standard, collateral standards, and particular standards

How lifecycle standards (risk management, usability, software) compare to type test standards in the 60601 family

Tangible changes to watch in the upcoming 4th Edition: clearer alarm requirements and impacts on design, QMS, & documentation

Why leaning on experts (internal or external) is key to getting this right for the impacts of 4th Edition

My goal is to “de-Greek” the process and show that IEC 60601 can be a roadmap 🗺, not a riddle

Whether you’re new to standards or a seasoned MedTech veteran, this episode shows how to approach IEC 60601 as a roadmap you can follow, instead of a riddle you can never quite solve.

What peers said

“If you want to know more about IEC 60601, Leo is the resource to go to … I recommend this episode to everybody working with medical electrical equipment.”

— Beat Keller

“Great to see how you became such an expert … I hope your story inspires young professionals to invest in becoming experts themselves.”

— Ronald Boumans

“It’s amazing that you covered the difference between process and test standards — there’s still a lot of confusion out there.”

— Tibor Zechmeister

Continue the discussion on this topic on LinkedIn

How We Can Help

If your team needs help with the IEC 60601 Series, or mapping the 4th Edition into your design controls, QMS, labeling, or testing strategy, my team at Eisner Safety Consultants and I are ready to support you.

Schedule a call with me, Leo, the IEC 601 Guy

]]> Join me for an Interactive Workshop Identifying Standards, Guidances, & Turn Standards into Your Competitive Advantage @ 10X https://eisnersafety.com/2025/03/31/join-me-for-an-interactive-workshop-identifying-standards-guidances-turn-standards-into-your-competitive-advantage-10x/?utm_source=rss&utm_medium=rss&utm_campaign=join-me-for-an-interactive-workshop-identifying-standards-guidances-turn-standards-into-your-competitive-advantage-10x Mon, 31 Mar 2025 22:50:00 +0000 https://eisnersafety.com/?p=7796

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.

]]> The most valuable asset we each bring to the table is⁉️ Our unique experiences and innovation https://eisnersafety.com/2024/09/30/the-most-valuable-asset-we-each-bring-to-the-table-is%e2%81%89%ef%b8%8f-our-unique-experiences-and-innovation/?utm_source=rss&utm_medium=rss&utm_campaign=the-most-valuable-asset-we-each-bring-to-the-table-is%25e2%2581%2589%25ef%25b8%258f-our-unique-experiences-and-innovation Mon, 30 Sep 2024 06:46:00 +0000 https://eisnersafety.com/?p=7706

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.

]]> How to ID Applicable Standards – Combinate Podcast https://eisnersafety.com/2024/08/07/how-to-id-applicable-standards-combinate-podcast/?utm_source=rss&utm_medium=rss&utm_campaign=how-to-id-applicable-standards-combinate-podcast Wed, 07 Aug 2024 21:08:23 +0000 https://eisnersafety.com/?p=7632  

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.

]]> Welcome 3 Global Experts to the Eisner Safety Consultants Team https://eisnersafety.com/2024/06/30/welcome-3-global-experts-to-the-eisner-safety-consultants-team/?utm_source=rss&utm_medium=rss&utm_campaign=welcome-3-global-experts-to-the-eisner-safety-consultants-team Sun, 30 Jun 2024 23:53:51 +0000 https://eisnersafety.com/?p=7612

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 his focus is 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 support, and the U.S.

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.

]]>

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.

]]> What’s The Relationship of Updated IMDRF N47 & N52 to IEC 60601-1, 4th ed? https://eisnersafety.com/2024/05/16/whats-the-relationship-of-updated-imdrf-n47-n52-to-iec-60601-1-4th-ed/?utm_source=rss&utm_medium=rss&utm_campaign=whats-the-relationship-of-updated-imdrf-n47-n52-to-iec-60601-1-4th-ed Thu, 16 May 2024 01:22:22 +0000 https://eisnersafety.com/?p=7546

💥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, 4th 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, 4th 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, 4th 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, 4th 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.

]]> IEC 60601-1 4th Ed Initial Launch: Positive Impacts Healthcare Standardization https://eisnersafety.com/2024/05/06/iec-60601-1-4th-ed-initial-launch-positive-impacts-healthcare-standardization/?utm_source=rss&utm_medium=rss&utm_campaign=iec-60601-1-4th-ed-initial-launch-positive-impacts-healthcare-standardization Mon, 06 May 2024 04:46:53 +0000 https://eisnersafety.com/?p=7532

Last week, 29 Apr – 3 May 2024, marked a significant milestone for the advancement in the world of patient safety and healthcare. The IEC TC 62/SC 62A convened its IEC 60601-1, 4th edition project kick-off meeting at AAMI in Arlington, Virginia. More than 200 experts from all corners of the globe attended in person, contributing to an inspiring and impactful week-long meeting.

The focus of this meeting was “level setting” all the parties on the development of requirements for the 4th edition of IEC 60601-1, which sets safety requirements for medical electrical equipment (also known as active medical devices). Twelve working groups (WGs) gathered to strategize their efforts, guided by the Design Specification for the 4th edition and the Architecture Specification.  The first day was set with training to help all parties get an understanding of project requirements and ask questions based on the Design Specification and the Architecture Specification. The next 3 days focused on the 12 WGs working on their strategies for the start of the project and the plans to move forward. The last day was a wrap-up and getting feedback on how to improve the process with lots of great discussion from the week. 

An Advisory Group (AG 50) is used to collaborate with all 12 WG co-convenors and secretaries, and IEC SC 62A officers ensuring the overall success of the project.

As a co-convenor for WG39, which addresses User Interfaces (Including information provided by the manufacturer, Alarm Systems and Usability Engineering Process), I am honored to be part of this excursion in the development of this standard for the support of the healthcare industry for the next edition. Alongside my co-convener, Martin Stangenberg, we led discussions and consensus-building within our WG. Our WG is comprised of amazing experts.  We had over 30 experts in the room including regulators from 5 countries; test houses; usability, labeling, alarm systems, and robotics experts. We had over half of our experts from the whole WG in attendance at the meeting. Our responsibilities include coordinating with other experts to develop basic safety and essential performance requirements related to User Interface Aspects Hazards for our part of the standard. Each WG is working on a different set of hazards as described in the post “IEC 60601-1, 4th ed. — Where do we stand?“.

WG 39 Group Photo

As an expert on WG37, I also spent part of the week with WG 37 developing requirements related to general issues concerning underlying concepts including basic safety & essential performance, single fault safety, type testing.  Correlation with processes relevant for IEC 60601-1 defined by other process standards (e.g., risk management) for IEC 60601-1, 4th ed.

It was great to meet all the new people and see them get involved for the first time in the standardization process as well as work with familiar faces I have worked with for many years. It is a well-rounded group of individuals, supporting this next edition, with many different perspectives but with the mindset to provide the patient with a safe product.

Closing Meeting

I extend my appreciation to all who have made this happen — the officers, the design specification and architecture specification teams (a long road to get here), my mentors, and all the national committee experts for coming together in this massive effort. Now the real work of the experts in the WGs begins….

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.

]]> Standards: Explosion and Challenges Maintaining/Updating https://eisnersafety.com/2024/04/18/standards-explosion-and-challenges-maintaining-updating%ef%bf%bc/?utm_source=rss&utm_medium=rss&utm_campaign=standards-explosion-and-challenges-maintaining-updating%25ef%25bf%25bc Thu, 18 Apr 2024 03:09:22 +0000 https://eisnersafety.com/?p=7518

 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.

]]> Happy MDR + Day 1 Past DoA https://eisnersafety.com/2021/05/27/happy-mdr-day-1-past-doa/?utm_source=rss&utm_medium=rss&utm_campaign=happy-mdr-day-1-past-doa Thu, 27 May 2021 07:51:44 +0000 https://eisnersafety.com/?p=6935

DATELINE 27 MAY 2021 (I will be adding some links below as I go as well): Wow! Some companies made it just across the line in time and I’m sure some didn’t. Did you? Not everyone agress with my perspective. Let’s get on with the story.

What does that all mean?

The MDD and AIMDD are dead (Dead on Arrival) and the MDR Date of Application (DoA) has just flown by us, yesterday. So, we are past the transition period, per say, for the MDR and now we’re into a grace (grey zone) for the legacy MDD/AIMDD products that can’t have any significant changes under their existing MDD/AIMDD certificates otherwise they need to go “full up” into MDR-land.

But wait there is more. All medical devices that are still certified by a Notified Body to the MDD & AIMDD with a valid CE certificate that can expire as late as May 26, 2024 have to comply with certain MDR requirements now which are based on Article 120(3) of the MDR. These requirements include: post-market surveillance, market surveillance, vigilance, and registration of economic operators or operators & of devices. Expect your Notified Body will be auditing you for these items.

On 26 May 2021 there were a lot of blog posts on the subject of MDR DoA, Article 120(3), Swexit, Turkxit, and so much more around this so rich subject so as a present to you I’m going to point you to some of my favorite resources and authors and some additional resources of interest that you may want to review:

Happy MDR DoA and Swixit / no Turkxit day! medicaldeviceslegal – Thx Erik Vollebregt for always explaining the nitty gritty of the MDR / MDD / AIMDD/ IVDD / IVDR to us. As a bonus I am adding LinkedIn post from Erik as well. You never know where the conversations may end up but they are always interesting.

D-0 MDR Day Monir El AAzzouzi of Easy Medical Device LinkedIn Post. Monir provide some great resources on MDR in the form of pdocasts and other training tools including blog posts. He recruits some of the best minds for his podcasts/webinars LinkedIn Posts, etc. He is quite the social media mogul.

And we are live! The MDR Hurdle race is on! Qserve Group – This podcast series is an excellent resource – I have known Gert for many years now. He is one of the heads of Qserve and has many years of Notified Body & Team NB expertise prior to joining Qserve. We have cooperated on some standards development work.

MDR’s Day One: Experts weigh in RAPS – RF News in FOCUS Series. Society for Regulatory Professionals. Has many good resources and growing. RAPS Regulatory Exchange is a great resource to exchange ideas and gain new information (you have to be a member to use this resource).

Important LinkedIn Posts from Mario Gabrielli Cossellu (Policy and Legal Officer at European Commission):

EU MDR Date of Application roundup: EMDN, eIFUs, UDI helpdesk, clinical investigation EMERGO by UL – This article is a summary of various items they are rounding up information on for the MDR but not specific to DoA issues.

Questions & Answers: Application of Regulation on Medical Devices – EU rules to ensure safety of medical devices Direct from the European Commission as of 26 May 2021.

NOTICE TO STAKEHOLDERS: STATUS OF THE EU-SWITZERLAND MUTUAL
RECOGNITION AGREEMENT (MRA) FOR MEDICAL DEVICES Notice from the European Commission on the Status of the EU – Switzerland MRA for Medical Devices.

Join the conversation on LinkedIn and add comments to the conversation there.

Confused by the MDR? 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. Feel free to schedule a call with Leo www.EisnerSafety.com/Schedule-Call/ or contact Leo at Leo@EisnerSafety.com or through our contact form at https://eisnersafety.com/contact_eisner_safety/.

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