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.