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.

Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR & IVDR.

Q4’ 2027: Article 123 (3) (d) MDR/113 (3) (f) IVDR

• Actor (Economic Operators register in EUDAMED; Supervising Entities has access to EUDAMED that is not public),
• Certificates (Active, suspended, reinstated, withdrawn, refused, other restrictions on certificates),
• MSU (Evaluation of devices on the market by Competent Authorities),
• Vigilance (& Post Market Surveillance), and
• CI/PS (Before a device is placed on the market – Clinical Investigation and Performance Study)

Q2’ 2029: Article 123 (3) (e) MDR/113 (3) (a) IVDR

• Devices (Based on UDIs registered in EUDAMED) and
• Certificates (see above)

* For a brief explanation of EUDAMED modules refer to the below

Need help with Medical Electrical Equipment standards (60601/80601 series) including Safety/EMC; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

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.

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.

The European Commission published two Implementing Decisions: EU 2022/6 and (EU) 2022/15 for the MDR (EU) 2017/745 and IVDR (EU) 2017/746
on 5 January 2022 and 7 January 2022
amending Implementing Decision (EU) 2021/1182 and (EU) 2021/1195
all above references are respective for the MDR and IVDR (1st MDR & 2nd IVDR)

MDR Harmonization

The addition of 9 new Harmonized Standards for the MDR including EN ISO 13485:2016/A11:2021 and EN ISO 15223-1:2021 are both finally added but unfortunately EN ISO 14971:2019/A11:202X wasn’t added. Hopefully, EN ISO 14971:2019/A11:202X should be added around March or April per Mario Gabrielli Cossellu.

I was really surprised by the Harmonization of EN IEC 60601-2-83:2020/A11:2021 as the base standard EN IEC 60601-1:2020/A11:202X was not included and none of the collateral standards (EN IEC 60601-1-XX) either. Add in the particular standards (EN IEC 60601-2-XX or EN IEC/ISO 80601-2-XX) that weren’t included which add in 70 standards in the series plus other applicable standards you are talking about a lot of standards just for medical electrical standards.

So, with these 9 new additions to the MDR list of Harmonized standards, there are now 14 references of Harmonized Standards in support of the MDR. A consolidated list for information purposes should be made available soon (per Mario Gabrielli Cossellu) on the harmonized standardization page for Medical devices – Regulation (EU) 2017/745.

Below is the list of the 9 new Harmonized Standards added to the MDR.

IVDR Harmonization

The addition of 5 new Harmonized Standards for the IVDR added the same two key standards EN ISO 13485:2016/A11:2021 and EN ISO 15223-1:2021 but unfortunately EN ISO 14971:2019/A11:202X wasn’t added. So, as mentioned as above we hope the EN ISO 14971 standard will be added on the next round of Harmonization of Standards for the MDR & IVDR. So, with these 5 new additions to the IVDR list of Harmonized Standards, there are now 9 references of Harmonized Standards in support of the IVDR. As mentioned previously a consolidated list for information purposes should be made available soon on the horizontal standardization page for In vitro diagnostic medical devices – Regulation (EU) 2017/746.

Below is the list of the 5 new Harmonized Standards added to the IVDR.

Past Prediction of EU Harmonization Process

I wrote an article for Med Device Online back in July 2019 for “Will We Have Harmonized Standards By The MDR’s Date Of Application?” I predicted pretty much from my pessimistic viewpoint, at that time, and of course now, that there was no way a significant amount of the Harmonized Standards for either regulation would be Harmonized through this process in time for the Date of Application back on May 26 of 2021. Now, six months later, past the DoA and we only have a handful of Harmonized Standards.

So, what is a manufacturer to do?

The safe and easy route is to follow what is in MDCG 2021-5 Guidance on standardisation for medical devices. From the “word on the street” most Notified Bodies will be following this Guidance. Section 3.5 of MDCG 2021-5 discusses the concept of “state of the art”… in detail and gets into the legal details. There is no legal status for “state of the art” but the term is noted in the GSPRs of Annex I of both the MDR & IVDR as noted … “taking into account the generally acknowledged state of the art.” The bottom line that I tell all my clients is you want to design using most recent standards to “State of the Art” and prepare all your Technical Documentation as will always will benefit you in the long run when you submit not only to your EU Notified Body but other National regulators around the world. They will expect you are using the latest standards out there which are related to “Stae of the Art”.

Need Help?

Need help with the 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 asking 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. 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/.

In my last post on this Standardization Request I didn’t expect it to pass. I didn’t get into the politics that there was a possibility of pressure from various groups for this Standardization Request to be accepted even if not perfect. Which it did. So, yes congratulations it passed but will we be able to get anything out of this document? Let’s hope, even though I’m not so hopeful if you read my last post.

So, officially we have a basis for the harmonization of the listed standards (Annex I & II) in the Standardization Request for the MDR and IVDR with CEN and CENELEC accepting the Request. The Policy Officer at the EC dealing with this is Mario Gabrielli Cossellu and he stated “This is the legal basis now in force to start publications in the OJEU of references of Harmonised Standards to confer presumption of conformity with the legal requirements of the Regulations. The first lists should be ready by June 2021 and periodically updated and enlarged.”

Now the BIG QUESTION is will Annex III of the Standardization Request be able to be met for any of the Standards that are to be Harmonized and will we ever get any Harmonized Standards for the MDR & IVDR?

In Annex III there are multiple examples:

For the “legal requirements to be supported by the harmonised standards”:

“Where a definition in a harmonised standard differs from a definition of the same term set out in Regulation (EU) 2017/745 or Regulation (EU) 2017/746, the differences shall be indicated in the foreword of that standard and in its Annex Z. That Annex shall also state that, for the purpose of using the standard in support of the requirements set out in Regulations (EU) 2017/745 and (EU) 2017/746, the definitions set out in those Regulations prevail.”

For the “Reduction of Risk”:

“The specifications of harmonised standards concerning the reduction of risk which may be associated with the device shall take into account the general requirements laid down in point 2 of Chapter I of Annex I of the MDR or IVDR to reduce risks as far as possible without adversely affecting the benefit-risk ratio.“

For the “Normative References”:

It’s a bloody mess and it would be hard to just repeat it all here so just look at it on your own. Realize a normative reference is a requirement whereas an Informative reference is optional and more for your information. So, in Annex III refer to Item 4.

There is more but I’m not going to continue as this sets the scene of the crime as you can plainly see by now.

Follow the full discussion and updates to this post on LinkedIn

Confused this is what Eisner Safety Consultants experts deal with all the time for countries for these and many other standards, regulations, laws, directives, and more. Leo Eisner is an expert on standards development and sit on many standards committees. Let us help you through this process. Need help with Essential Performance. 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/.

Notified bodies can now do remote audits for the MDR and IVDR — Member states need to Notify the EU Commission of Notified Bodies not conducting on-site audits & the period of time this will not be happening. So remote audits for these NBs won’t be happening immediately – but this is a big change! EUR-Lex – 52021XC0111(01) – EN – EUR-Lex Each Competent Authority will need to review each separate NB’s justifications and procedures separately and this is a COVID-19 exemption only so this is temporary. Once the Commission says COVID-19 crisis is over this goes away.

Follow this discussion on LinkedIn

Stop the Presses and add these earth shattering Regulations to your reading list for the next week or two:

• Medical Device Regulation (EU) 2017/745 and
• In Vitro Diagnostic Regulation (EU) 2017/746

Bassil Akra of TÜV SÜD some of the costs of this transition in his post on LinkedIn. It ain’t going to be cheap!

Back to our regularly scheduled post:

This Friday 5 May 2017 should be marked in your calendar or journal as a momentous date when the EU Official Journal will publish the Medical Device and In-Vitro Diagnostic Regulations and the transition periods for both start (3 years for the MDR & 5 years for the IVDR)!!  This is the start of a turning point for many medical device and IVD manufacturers as the clock starts ticking away til the end of the transition periods of these new Regulations.  If you haven’t started your transition planning strategies for your products & product families the pressure should be mounting quickly as there is so much to deal with for this transition time. Check out these resources for learning more about the MDR & IVDR. See below for some more details about the challenges you need to consider and START PLANNING for NOW (don’t wait)!

There is no grandfathering once the transition period ends for the applicable Regulation.  So, in 3 years and a day or so if you don’t meet the MDR or 5 years & a day or so if you don’t meet the IVDR you won’t be able to CE Mark your device and sell or distribute your medical or IVD device in the EU (& hopefully the UK which is in the middle of Brexit implications as UK will not be part of the EU by end of transition period).

We have talked about some of the challenges in the implementation of the MDR but here are more details to consider for your strategic planning:

• New definitions to deal with including nanomaterial, Unique Device Identifier, interoperability, economic operator, among other new & modified definitions.
• Person Responsible for Regulatory Compliance: Identify personnel that is  responsible for regulatory compliance with the Regulation and have a minimum work experience in the applicable device field and a minimum of academic qualifications.
• Enormous Single EU Database (not ready yet): Impacts all Economic Operators (which includes manufacturers) – Will register all devices, manufacturers, Economic Operators, CE Certificates, new clinical investigations, & incident reporting.  Will manage all Unique Device Identifications and Single Registration Numbers (SRN).
• Regulations are much more explicit now for the Quality Management System (QMS) & Risk Management System (RMS) requirements.  Beyond just what is in EN 13485 (ISO 1385:2016) & EN 14971
• Economic Operators (new to MDR): Impacts the activities of EU Representatives, Importers, Distributors & Manufacturers – Different Responsibilities depending on type of Economic Operators.
• Traceability of Devices Between Economic Operators: Between all Economic Operators (wow that in itself can be huge!) and all the way down to the healthcare institutions & in some cases down to the patients devices used on.
• Annex I now called Safety & Performance Requirements (not Essential Requirements): Much more prescriptive, addition of UDI & SRN to labelling requirements, all manufacturers will need to update all their Annex I checklists, new Clinical Evaluation & Clinical Performance Evaluations requirements
• Clinical Data: Much more prescriptive especially for higher risk class devices (class III & implantable devices) – Clinical Investigations needed in many cases now & restrictions of the type of clinical data allowed for class III devices (much more restrictive using equivalency data), post market clinical follow-up requirements for high risk class devices (i.e. annual summary reports for Class III & implantable devices).
• Notified Bodies: Much more prescriptive in competency requirements, conflict of interest, designation process, etc.  The end result is fewer Notified Bodies & Notified Bodies with narrower scopes after the designation process.  Also, with the nexus of  the EU regulations, Canada’s MDSAP requirements, and medical device manufacturers transitioning to ISO 13485:2016 the Notified Bodies resources are being strained which means less resources available to the medical device manufacturers. The limited resources means it may be a challenge to complete these processes without hitting the edge or past the transition period so start now or you may not be able to keep all your CE medical devices on the EU market in about 3 years from now when the clock runs out.

If you need help with your EU MDR or IVDR transition planning please email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants.