Join me, Leo Eisner, The IEC 60601 Guy, as I lead an interactive and fun workshop at the 10X Medical Device Conference in Newport Beach, Ca on May 7 – 8, 2025. Turn Medical Device Standards into Your Competitive Advantage, and discover practical strategies to leverage standards, avoid costly errors, and accelerate your product development cycle.

Don’t make the 5 costly mistakes companies make with Medical Device Standards. Learn from the IEC 60601 Guy himself.:

• Late Identification of Applicable Standards: Leads to expensive redesigns and delayed timelines
• Ignoring Expert Standards Guidance: Results in regulatory rejections and costly resubmissions
• Unprepared Risk Management File for Testing: Risks unnecessary costs due to lack of strategic planning for compliance.
• Unprepared Regulatory Submissions: Leads to costly setbacks and market-entry delays
• Underestimating Education and Training: Creates knowledge gaps, increasing errors and compliance risks.

I want to thank Sean Smith and his team from 10X for all his help and dedication for putting on this event. He is doing an amazing job and please contact him if you are interested.

Need help with standards?

We provide support for your design and development process for regulatory submissions.? Eisner Safety Consultants can help by

• Assisting with strategic compliance planning for your medical electrical product lines,
• Providing regulatory support when FDA or a regulator asks technical questions on your submission.
• Identification of applicable standards, laws, regulations, guidances, and directives up front to support your design process effectively.
• Design Documentation Reviews providing expert analysis supporting the design development process to avoid unnecessary design and development delays.
• We provide EU, US, and other countries regulatory requirement reviews of standards, laws, directives, and guidance.
• Providing support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs, and more.
• Interfacing with test houses for medical safety, EMC and arrange other testing.

Feel free to schedule a web meeting with Leo or contact us.

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

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

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

Changes proposed:

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

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

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

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

 Added concept of “applicable policy”

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

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

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

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

Deleted 4 b)

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

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

updated the normative references

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

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

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

Need Help?

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

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.

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

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

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

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

Need help with 60601 series standards including EMC; strategic compliance planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Eisner Safety Consultants team of experts also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs and more. His team includes experts on additional standards committees and we all talk to the regulators regularly. We’re here to support your needs.

We work with many test labs for Medical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

Feel free to schedule a web meeting with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

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.

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.

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.

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/.

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):

• Meetings of the MDCG 27 – 28 May 2021 takes place
• Updates to the NANDO db of Notified Bodies related to MDD & AIMDD transitional provisions of Article 120of MDR & note able to issue new certificates for MDD & AIMDD
• EC’s Q&A
• EC Press Release 26 May 2021 “Public health: Stronger rules on medical devices”
• Today is MDR Day

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/.

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/.