Updated 22 Dec 2020 – In the last couple of years, the FDA has started to post the standards updates on their Recognized Consensus Standards db prior to publishing in the Federal Register (FR). This year, being the year we all will not forget (thx COVID-19), the Fall update was delayed longer than normal. It was just published today (21 Dec 2020). I have been asking my associates at the S-CAP (Standards and Conformity Assessment Program) for the last several weeks / months when the update would show up and they haven’t been able to give me a straight answer. Finally, it showed up! Below is a spreadsheet of the standards that have updated as of 21 December 2020. 99 standards were added to the FDA standards db. The IEC 60601 Amendments IEC 60601-1-2 ed. 4.1, IEC 60601-1-6 ed. 3.2, IEC 60601-1-8 ed. 2.2, IEC 60601-1-10 ed. 1.2, IEC 60601-1-11 ed. 2.1, IEC 60601-1-12 ed. 1.1 have all been added to the db.

Surprisingly, IEC 60601-1 ed 3.2 is not included in the Recognized Consensus Standards db update. Only AAMI ES60601-1:2005 + A1:2012 (FR Recognition # 19-4) or the 60601-1 ed 3.1 with US national deviations is still in the db.

Update to post — 22 Dec 2020 — I just found out from the FDA they are awaiting the update of ANSI AAMI ES 60601-1 before they add to the FDA Recognized Consesnsus Standards db. AAMI just sent out ANSI AAMI ES 60601-1 A2 to the ES committee for vote, which I am on, so my guess is it will publish around April if there are no snags or negative votes.

IEC 60601-1-9 ed. 1.2 is not on the FDA list as 60601-1-9 isn’t a Recognized Consensus Standard. Also, a reminder that IEC 60601-1-3 was not part of the original Amendments project but now is scheduled to be updated as an IEC standard in March 2021. So, FDA hopefully will add to their Spring 2021 update. It is a really minor update with mostly just references to updates of the general standard being updated to ed 3.2 (2020).

Standards are a key priority for the International Medical Device Regulators Forum (IMDRF).

Its forthcoming guidance, “Optimizing Standards for Regulatory Use,” encourages the development of ‘regulatory ready’ standards, including direction to Standards Development Organizations (SDOs) to consider medical device ‘essential principles’ when writing standards.

This webinar will introduce viewers to IMDRF, review this upcoming guidance, and discuss the role IMDRF and its priorities play in relation to international medical electrical equipment standards in the IEC 60601 series (IEC 60601-X-YY / IEC/ISO 80601-2-YY), proposed IEC 60601 series updates, and significant changes planned for the draft IEC 60601-1 Ed3.2.

Finally, it will summarize why standards conformity assessment is critical to ensure success of global harmonization.

This webinar is being co-presented by me, Leo Eisner, the “IEC 60601 Guy”, founder and principal regulatory & product safety consultant at Eisner Safety Consultants, along with Captain Scott Colburn and Gail Rodriguez of the FDA, and moderated by Jon Speer of Greenlight Guru.

WHEN: November 1, 2018 1PM ET/10AM PT

Sign-up now for the limited live seating of the free webinar

Top Take Aways

• Overview of IMDRF
• IMDRF’s forthcoming guidance “Optimizing Standards for Regulatory Use”
• Key concept of the Essential Principles of Safety & Performance
• Concept of Essential Performance in IEC 60601 standards for medical electrical equipment and how it relates to the Essential Principles
• Upcoming major changes and revisions to the IEC 60601 series

Who Should Attend?

• Medical Device Industry Executives
• Regulatory Affairs Professionals and Management
• Quality Professionals and Management
• Clinical Affairs Professionals and Management
• R&D Engineers and Management
• Regulators
• Standards Development Organizations and Standards Developers
• Test Labs
• Accreditors

IMDRF History & Further Details About Webinar

The International Medical Device Regulators Forum (IMDRF) was established in February 2011 as a forum for a voluntary group of medical device regulators from around the world to promote medical device regulatory harmonization. Standards, as an important resource for harmonization, are a key priority for IMDRF. The draft IMDRF guidance “Optimizing Standards for Regulatory Use” is primarily directed at regulatory authorities (RAs), Standards Development Organizations (SDOs) and those interested in the application of standards to support regulatory frameworks (i.e. manufacturers), the guidance aims to encourage the development of ‘regulatory ready’ standards, including direction to SDOs to consider medical device ‘essential principles’ when writing standards. Essential principles, which are outlined in ISO 16142 and currently under development at IMDRF, will include references to medical device performance.

The IEC 60601 series of standards for medical electrical equipment and systems also feature expectations for essential performance. We will highlight the intersection of the two key concepts between the essential principles and the IEC essential performance to demonstrate how standards can help with global harmonization in medical device regulation.

Further, we will provide a brief update on the latest standards revision status for the IEC 60601 series, including some significant changes planned for the draft IEC 60601-1 Ed3.2.

About Leo Eisner

Leo is heavily involved in the IEC 60601 standards development process for several of the standards in the series. He is the US Co-chair for IEC SC62D in charge of a majority of the IEC 60601-2-XX / IEC/ISO 80601-2-XX Particular Standards. He is on several Working Groups and Maintenance Teams working on the development of the draft IEC 60601-1, edition 3.2 (3rd edition + Amendment 2).

Eisner Safety Consultants has helped countless clients thru the Regulatory and Product Safety maze over our 22 year history of the company. Leo has over 30 years experience in product safety and 24 years experience in the medical device industry. Leo ran the Compliance Engineering Group at Karl Storz and was a Senior Product Safety engineer at TÜV Product Service prior to starting Eisner Safety Consultants. Leo has worked as a Notified Body auditor and technical reviewer for TÜV Product Service/SÜD, NSAI, and is currently a technical reviewer for Pre-Safe (Joint venture between NEMKO & DNV).

About greenlight guru

greenlight.guru is the only Quality Management Software built exclusively for the unique needs of medical device companies, allowing you to bring safer devices to market faster while reducing risk and ensuring compliance. Visit their home page to learn more.

About Eisner Safety Consultants

Leo is heavily involved in the IEC 60601 standards development process for several of the standards in the series. He is the US Co-chair for IEC SC62D in charge of a majority of the IEC 60601-2-XX / IEC/ISO 80601-2-XX Particular Standards. He is on several Working Groups and Maintenance Teams working on the development of the draft IEC 60601-1, edition 3.2 (3rd edition + Amendment 2).

Eisner Safety Consultants has helped countless clients thru the Regulatory and Product Safety maze over our 22 year history of the company. Leo has over 30 years experience in product safety and 24 years experience in the medical device industry. Leo ran the Compliance Engineering Group at Karl Storz and was a Senior Product Safety engineer at TÜV Product Service prior to starting Eisner Safety Consultants. Leo has worked as a Notified Body auditor and technical reviewer for TÜV Product Service/SÜD, NSAI, and is currently a technical reviewer for Pre-Safe (Joint venture between NEMKO & DNV). We provide assistance with U.S., Canadian, European, & other international regulations. Learn more about our services we offer.

ABOUT FDA CDRH
In keeping with our mission, the Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health. We assure that patients and have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

We seek to continually improve our effectiveness in fulfilling our mission by planning strategically and regularly monitoring our progress.

• Recognition and Withdrawal of Voluntary Consensus Standards: Draft Guidance
• Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices : Final Guidance

Podcast on Standards & FDA’s Release of these Guidance Documents

FDA’s Captain Scott Colburn and Leo Eisner of Eisner Safety Consultants did a podcast with Jon Speer of Greenlight Guru on Standards Development of the IEC 60601 Series and these recently released Guidance documents. Listen to this conversation…

Some of items of note with the Final FDA Guidance include:

• FDA can now Recognize a standard and place on the Recognized Consensus Standards db prior to a formal Federal Register updates
• Declaration of Conformity (DOC) to follow requirements of ISO 17050-1 or as specified in the Final Guidance in section IV. A. (1)
• DOC process different for Consensus Standards that are horizontal, process-oriented, or that include choices relating to test methods, test selection, or have guidelines that apply to a broad range of device types and safety issues then FDA recommends submitters follow ISO 17050-2 – Supplier’s DOC – Supporting Documentation per section IV. A. (2) of the Final Guidance

IEC 60601-1, edition 3.2 (draft) and it’s collateral standards (IEC 60601-1-XX) are being updated and Leo discusses why this is happening, the timing and some of the impacts on manufacturers and design houses in this podcast.

FDA Guidance Documents – Additional Information

The draft guidance will be open for public comments and suggestions for 60 days at https://www.regulations.gov under Docket Number: FDA-2018-D-2936.

The Appropriate Use of Voluntary Consensus Standards final guidance describes the appropriate use and documentation of consensus standards for premarket submissions and how FDA staff intends to rely on consensus standards during the review process. Appropriate use of voluntary consensus standards can reduce requests from FDA staff for additional information to address issue(s) the standard was intended to address.  This guidance provides further clarity and explanation about the regulatory framework, policies, and practices regarding the appropriate utilization of consensus standards for premarket submissions.:”

Webinar about the Appropriate Use Final Guidance:

FDA will be hosting a Webinar on Thursday, October 25th, 2018. The webinar will be for manufacturers & others interested in learning more about the Appropriate Use final guidance. No registration is required.

• Time: 1:00 – 2:00pm EST (To ensure you are connected, dial-in prior to the start of the webinar)
• To hear the presentation and ask questions:
  Dial: 800-475-0481, International Callers Dial: 1-517-308-9467; Conference Number: 8090070; Passcode: 2387655
• To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW8090070&p=2387655&t=c
• Following the webinar, a transcript, audio recording, and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.

Need help sorting out the proper medical device standards that apply to your device submission for the US, Canada, EU or elsewhere? Contact Leo “the IEC 60601 Guy” Eisner to help you thru this process at Leo at EisnerSafety dot com or schedule a call with Leo.

View all the articles I have written for InCompliance Magazine.

I hope you enjoy this article and if you have any questions please feel free to contact me at Leo at EisnerSafety dot com or schedule a call with me.

Let’s start with some really big news!!!

It is anticipated in 2019 IEC 60601-1 edition 3 + Amendment 2 will be published & around 2024 we anticipate that 4th ed. of IEC 60601-1 will be published.

If you want more details about what is happening with the IEC 60601-1 changes so you can plan for these big changes consider our Standards Annual Reports on the Medical Electrical Equipment Standards and/or Home Use Medical Electrical Equipment Standards which goes over what is happening with draft and newly released standards and technical reports.

We are offering a “Special April 2016 Flash Sale” on the Standards Annual Reports discount for new customers and a super deep deep discount pricing for our loyal customers

We have broken this post into national areas

• USA FDA
• EU MDR & RoHS-2
• IMDRF Update
• Brazil
• China CFDA & China RoHS-2
• Russia
• Home Health Care Articles
• Standards Update
  • So much is going on with ISO 13485:2016 (links to details below) – “Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes”.   Also, we keep adding to the post on ISO 13485:2016 is Now Available – Start Planning Your Transition.  Come and find all the great resources we link you with and also read the post to learn the steps to start your transition planning..
• New Strategic Services to help your Company in 2016 & into the future
  • Strategic Reports on Future Development of Standards that impact your Medical Devices – Flash Sale for April 216 – this service helps you strategize your product development process to know in advance when changes to standards may impact your devices and save you a lot of money in the long run.  A great example is will you be ready for the major changes that IEC 60601-1-2, 4th ed. will place on your products?  What is going on with changes in process for IEC 60601-1 3rd ed. + Amendment 2 and the future 4th ed.?

  • BIG PRICE DROP ON OUR

    Standards Reconnaissance Database – this service helps you maintain your list of standards, be up to date on current and new /developing standards.  Also, get strategic information about the future of these current, new and developing standards.  Save time and money using this service that would take you many more hours than the cost of this service to keep up to date on these standards.

Now only $900/yr for our Base subscription level or $1650/yr for a Full subscription level.  These are sale prices so get them while they last.  We have updated our service to make it more affordable but with the same information except we removed the annual report.  You get a better annual report in the above service that is much more detailed than we were offering with our db.

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USA
FDA – Are you aware of the many issues with  FDA? Here are some of the relevant issues to keep up on

1) FDA Device Regulations, a few of which are coming later in 2016.  The FDA has a transparency initiative known as the Transparency Results Accountability Credibility Knowledge Sharing (TRACK).  The database shows what is expected for upcoming proposed and final rule making.  A couple of the items on that list are noted here. The dates in the db don’t guarantee the release of those rules. More information on the process the FDA follows to issue Rules & Regulations.

a) Use of Symbols in Labeling

Abstract “The purpose of this rule is to allow for the inclusion in device labeling of stand-alone symbols established as part of a standard developed by a national or international standards development organization, provided that such symbols are explained in a symbols glossary that is included in the labeling for the medical device. The rule also revises prescription device labeling regulations to authorize the use of the symbol statement “Rx only” on the labeling of prescription devices.”  One of the standards referenced is AAMI/ANSI/ ISO 15223–1:2012, Medical Devices— Symbols to be Used With Medical Device Labels, Labeling and Information to be Supplied, Part 1, General Requirements. The proposed rule announcement was published in the Federal Register on April 19, 2013.  The final rule is scheduled for March 2016 but as mentioned above the dates may not always be met.

b) Declaration of Labeling for Home-Use Devices

Abstract: “The purpose of the proposed rule is to require certain medical device establishments listing home-use medical devices to submit, in electronic format, the label and package insert of such certain medical devices listed with FDA. FDA intends to make the information from the submitted labeling accessible by the public through a focused Internet site.”  This is in the proposed rule stage and is expected to be issued around May 2016 if on time.

c) Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System

Abstract: “The proposed rule would establish special controls for the computed tomography (CT) X-ray system. A CT X- ray system is a diagnostic X-ray imaging system intended to produce cross-sectional images of the body through use of a computer to reconstruct an image from the same axial plane taken at different angles. High doses of ionizing radiation can cause acute (deterministic) effects such as burns, reddening of the skin, cataracts, hair loss, sterility, and, in extremely high doses, radiation poisoning. The design of a CT X-ray system should balance the benefits of the device (i.e., the ability of the device to produce a diagnostic quality image) with the known risks (e.g., exposure to ionizing radiation). FDA is establishing proposed special controls, which are necessary to provide reasonable assurance of the safety and effectiveness of a class II CT X-ray system.” This is in the proposed rule stage and is expected to be issued around July 2016 if on time.

2) FDA continues to issue lots of Draft & Final Guidances.  Here are some relevant ones since our last update in Jan 2016:

a) Draft Guidance (Issued on January 26, 2016) – Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices – Draft Guidance for Industry and Food and Drug Administration Staff

b) Draft Guidance (Issued on February 3, 2016) – Applying Human Factors and Usability Engineering to Medical Devices – Guidance for Industry and Food and Drug Administration Staff

c) Draft Guidance (Issued on February 3, 2016) – Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development

d) Draft Guidance (Issued on February 3, 2016) – Linked with Item 2)b) Guidance. This Guidance provides a List of the Highest Priority Devices for Human Factors Review per FDA.  As this is a draft Guidance this list is not final but one I would highly recommend you follow, if you are submitting a product that is on this list, for a regulatory approval thru the FDA. – List of Highest Priority Devices for Human Factors Review – Draft Guidance for Industry and Food and Drug Administration Staff

e) Draft Guidance (Issued on February 9, 2016) – Display Devices for Diagnostic Radiology – Draft Guidance for Industry and Food and Drug Administration Staff

f) Final Guidance (Issued on March 7, 2016, the draft of this document was issued on January 27, 2015) – Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails – Guidance for Industry and Food and Drug Administration Staff

g) Draft Guidance (Issued on March 7, 2016) – Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes – Draft Guidance for Industry and Food and Drug Administration Staff

h) Final Guidance (Issued on March 22, 2016, the draft of this document was issued on June 29, 2015) – Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices – Guidance for Industry and Food and Drug Administration Staff

3) FDA national evaluation system for medical devices announcement on 4 April 2016: “Establishing a national evaluation system for medical devices is one of CDRH’s 2016-2017 strategic priorities. A national evaluation system is a collaborative system that monitors, links, and analyzes real-world data from many different sources—including clinical registries, electronic health records and medical billing claims— across the medical device landscape with the goal of better understanding how medical devices perform. By harnessing such real-world data using state-of-the-art techniques, such a system will provide information that not only contributes to regulatory decisions, but also promotes device innovation, and importantly provides timely and meaningful information directly to patients and their physicians.

Today, as an outcome of a cooperative agreement with FDA1, the Duke-Margolis Center for Health Policy published its vision on a coordinating center for such a system. “Better Evidence on Medical Devices: A Coordinating Center for a 21st Century National Medical Device Evaluation System” describes expectations for a national evaluation system’s Coordinating Center (you may recall that the planning board called for a Coordinating Center in its February 2015, “Strengthening Patient Care: Building a National Postmarket Medical Device Surveillance System”). The Coordinating Center will guide the future development and implementation of a national system.

Today’s publication is an important step toward building a national evaluation system. For more information about a national evaluation system, please visit the FDA’s National Evaluation System webpage.”

4) FDA on 4 April 2016 published in the Federal Register their latest updates to the list of Recognized Consensus Standards with some new additions, some updates and some withdrawals.  This is List 041 as published in the Federal Register and has some important updates that include finally adding in the IEC 61010-1 Lab Equipment standard among many other changes.  As of April 5, 2016 the Recognized Standards database has not been updated with these new standards updates.

5) Updated FDA Web Page on “Interference between CT and Electronic Medical Devices“. Last Updated on 31 March 2016.

6) Updated FDA Web Page on “eMDR System Enhancements“. Last Updated on 31 March 2016.

Part of the Standards Reconnaissance Database Service will include a listing of current FDA CDRH Guidances Final & Draft plus we will be adding in the Canadian and Europe Guidances, as well. We will be launching this stage 2 in the next month or so. Learn more about this db.  If you would like a live demo of the db please contact me directly at Leo@EisnerSafety.com.

EU  

Updates on the Draft EU Medical Device and the In-Vitro Diagnostic Regulations

This is a moving target but there are some really good resources for updates on these draft Regulations and my favorite sources to find out info on this topic are Erik Vollebregt’s Blog called www.medicaldeviceslegal.com, the MedTech Europe website (MedTech Europe is an alliance of European medical technology industry associations. It currently has two members: EDMA, representing the European in vitro diagnostic industry; and Eucomed, representing the European medical devices industry), and BSI’s updated white paper on “The proposed EU regulations for medical and in vitro diagnostic devices: An Overview of the likely outcomes and consequences for the market” (You need to fill out a form to download the White Paper but it is totally worth it). Anything new with Erik’s & MedTech Europe’s sites of late:

1) On Erik’s site he has done a post titled “Medical devices M&A – data protection” and it focuses on data protection in the EU is a major issue that needs to be addressed seriously and hopefully early enough on in a company’s history so when you are at the Mergers and Acquisition stage you aren’t trying to gigger with it at this late date as it could devalue your sale of your company.
2) In our previous Global Update MedTech Europe wrote about Advocacy activities related to the MD & IVD Regulations. It also looks at the past and future work to be done.

EU RoHS-2 – Courtesy GreenSoft Technology, Inc.

The Bulk of RoHS-2 Exemptions Expire This July: Be Prepared!

Renewal Requests Submitted for Large Number of EU RoHS-2 Exemptions

IMDRF Update  

IMDRF Offers Progress Updates at March Meeting in Brazil – Excellent update by RAPS Regulatory Focus which discusses the various updates by the Regulators including on the Medical Device Single Audit Program (MDSAP) and it’s progress, presentations on the topic of Software as a Medical Device, and current work summary for IMDRF (See below listing).

Current IMDRF work items include:

1. Medical Device Single Audit Program (MDSAP)

2. National Competent Authority Report (NCAR)

3. Software as a Medical Device (SaMD): Clinical Evaluation

4. Regulated Product Submission (RPS)

5. Patient Registries

6. Adverse Event Terminology

7. Good Regulatory Review Practices – Competence and Training Requirements for Pre-market Reviewers and Product Specialist

 Brazil IEC 60601-1-9 required End of 2016 Are You Ready?

Refer to our recently released blog post dated 6 April 2016. 

China  

CFDA – (China Food & Drug Administration) – Articles Courtesy CIRS-MD

Summary of Medical Device Guidelines of 2015 in China – In order to standardize the supervision and strengthen the guidance of medical device registration, CFDA had conformed and released a series of Medical Device Guideline in 2015. These guidances will help you prepare your submission dossier and for registration evaluation. What to include inside Guideline? and What guidelines did CFDA release?

“Guideline for Medical Device Good Supply Practice On-site Inspection”Interpretation – In order to strengthen the supervision and management of medical device distribution, standardize and guide the Good Supply Practice (GSP’s) on-site inspection, CFDA has formulated the Guideline for Medical Device Good Supply Practice On-site Inspection, issued Oct.15th , 2015. How to deal with the on-site inspection, and what is the criteria of inspection result determining?

“Administration Regulations for Instruction and Label of Medical Device” Interpretation – CFDA has put Administration Regulations for Instruction and Label of Medical Device (click on the Documents tab to get the regulations text) into effect on 2014.10.01, and issued the interpretation of this regulation to help enterprises to have better understanding of this regulation on 2015.02.05. What are the requirements of medical device instruction and label and their content? what are the contents forbidden in the instructions and labels?

“Administrative Measures for Quality Supervision on the Use of Medical Devices” – On Oct 23th, 2015, China Food and Drug Administration (CFDA) has promulgated Administrative Measures for Quality Supervision on the Use of Medical Devices to strengthen the management of the use of medical devices. According to the regulation, medical device use parties shall set up appropriate quality management system, which includes two aspects: one involves purchase, acceptance check and storage; another one involves use, maintenance and transfer.

CFDA 2015 Medical Device Regulatory Data Analysis – CFDA has released the 2015 Food And Drug Regulatory Statistical Annual Report, which announced the objective data about health food, drug, medical device and cosmetic. The data involved with manufacture, distribution, registration, and so on. This article discusses medical device regulatory data from 2012 to 2015 which involved with the number of Medical Device Registration during 2011~2015, as well as medical device manufacturers and distributors.

Final China RoHS-2 Regulation Published – Courtesy GreenSoft Technology, Inc. 

Russia   

Recently I found an English version of the Roszdravnadzor* website (Federal Service for Surveillance in Healthcare).

*”Roszdravnadzor executes the state supervision over observance of the Russian Federation legislation regarding the state supervision over quality and safety of medical practice, compliance to the procedures of healthcare provision and the standards of medical care by institutions and individual medical practitioners.

Home Health Care Articles Courtesy of HomeCare magazine

The Homecare Technology Race

Keeping Seniors in Their Homes with Technology

The Future of Home Health

Standards Updates  

ISO 13485:2016 – Medical devices. Quality management systems. Requirements for regulatory purposes

This segment has been update since the Publication of the ISO 13485:2016 standard.

The standard has been published as an International Standard. It was published late February but the official date on the ISO version of the Standard is March 1, 2016.
A white paper  by the Working Group WG1 of the Technical Committee TC210 proposed that there be a three (3) year transition period.  From what I have seen this seems like it will be followed but I would recommend that you check with your Notified Body or Certification Body that you are using for your Quality System Certificate to ensure you are on the same time schedule they are.

The proposal from the white paper says:
This phase concerns the co-existence of the availability of accredited certification to ISO 13485:2003 and ISO 13485:2016. It is recommended to ISO TC 210 that this phase last for three years, during which time users will have to update their quality management systems to meet the requirements of ISO 13485:2016 to an accredited certificate. It is recommended that the users of ISO 13485:2003 work with their certification bodies or registrars to schedule an upgrade audit at a convenient time within the transition period.
It is recommended that:

Two years after the publication of ISO 13485:2016 all accredited certifications issued (new certifications or re-certifications) will be to ISO 13485:2016.
Three years after publication by ISO of ISO 13485:2016, any existing certification issued to ISO 13485:2003 will not be valid.

If you are ready to start planning your transition to ISO 13485:2016 enjoy our blog post on the subject with lots of additional resources that have been added since the original post.

Find out more about this standard from a presentation done back in Feb 2016.  You can get the recording and the slide deck.  You’ll learn how to prepare for the coming regulatory changes, get a general overview of the standard & its most significant changes, and a lot more. Our strategic partners greenlight.guru will ran this free Webinar titled “Understanding the Changes to ISO 13485:2016”. It was presented by Mark Swanson who is a member of the ISO 13485 working group. Click this link to get the on-demand recording.
Also, if you want more info on the standard now you can listen to a podcast on the subject too.

New Strategic Services to help your  

Company in 2016 and into the future

Strategic Reports on Future Development of Standards that impact your Medical Devices

April 2016 Flash Sale on Reports for New Customers & Existing Clients* **

For most companies it is quite expensive to have one of your employees be a committee member for the development of standards.  For example a US company would have to pay annual dues to ANSI & AAMI (AAMI’s dues are based on your Gross profits) for the company & the employee, pay for the travel costs to the meetings, and there is a significant time commitment of the employee for the meetings & additional time commitment expected of committee members to be involved in the standard development process.
There is an alternative to this expensive venture for medical device companies that design & market electrical medical devices.  I, Leo Eisner, can be your eyes and ears so you can learn what the plans are for new and existing standards without the extensive resource and financial commitment to your organization.

These reports are available and if you are a current or past client you get an extra special discount (See * & **).  For the month of April 2016 we have slashed prices for these reports for new customers and deeply discounted the reports for current (project open already) and past clients (See * & ** notes for client rates).

A single report was $3,500 (US$) per report or for both of them was $6,500 (US$) and NOW new customers can get them for only $2,500 (US$) for a single report and both reports for $4,500 (US$).  This is a steal compared to the time I socked into each one of these reports, the meetings I sat in on for 2 weeks in Nov 2015 in Japan (Kobe & Tokyo), and also the money saved not having to be on the committees, the travel expenses for getting to the meetings,  the time in the meetings, and the expected contribution to the standards development for being in these committees.  That is a lot of man hours that you get inexpensively from my hard work.

New Customers can purchase a copy of these reports now. Leo at EisnerSafety dot com or call us at 503-244-6151.

* Current & past Eisner Safety Consultants Clients are eligible for a $1,000.00 (US$) discount if you grab this deal for one reports during April 2016.  So, one report is only $1,500.00 (US$) to my loyal customers during April 2016.  Payment must be by check or bank wire to receive this discounted price.  Please contact us to arrange for this special discount.

** Current & past Eisner Safety Consultants Clients are eligible for a $2,000.00 (US$) discount if you grab this deal for both reports.  So, both reports are only $2,500.00 (US$) to my loyal customers during April 2016.  Payment must be by check or bank wire to receive this discounted price.  Please contact us to arrange for this special discount.
Please contact me with any question on this service at Leo@EisnerSafety.com or 503-244-6151

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Available features and additional details on the Standards Reconnaissance Service

Free Subscription Level is available too for those that want to test drive parts of the system:
For those that want to test drive the system we do have a free subscription level so you can see how the system works with less details available. To subscribe for the free service level select the Free Subscription Level when Registering on the Subscription Levels page.

(Note this service is not offered anymore please contact us with your questions.)

Do you make Medical Electrical Equipment & Systems (MEE&S) or Home Use MEE&S? Are you up to date on all the applicable Current & Draft Medical Electrical Equipment Standards, Technical Reports, etc?

Do you have the resources to do this efficiently and with minimal cost & time?

1. Are you able to have one or more employees from your company sit in all the standards developing meetings to write the standards?
2. Can you afford the high fees of being on the National Committees?

If not, consider an Industry Leader’s specialized Annual Reports on Medical Electrical Equipment & Systems (MEE&S) Standards or on Home Use MEE&S Standards. Leo Eisner has over 20 years experience in the medical electrical equipment product safety industry with standards development as one of his primary focuses for over 12 years and he is on many of the standards committees that develop the standards in these reports both on the MEE&S and Home Use MEE&S markets.

What are the implications if you don’t stay up to date on these critical documents?

1. You may need to redesign your product before submitting to a regulatory agency for review and approval,
2. Your Notified Body Auditor or your Quality System Certifier may issue a Non-Conformance for not being up to date on the applicable standards and technical reports that apply to your products.
3. Your regulatory strategy for your products lines may be out of date which could delay your products getting to market on time.
4. And more….

If you’re a medical device company that makes any type of electrical equipment you will want one or both of these reports as there are a lot new standards, Technical Reports and related documents recently released and also being developed that you should be on top of. Many Medical Device Companies don’t have the resources (time & money) to afford to have someone sit in the standards meetings, commit to the time to support the committee work to write the standards, and pay the high fees needed to be a national committee member of ANSI, AAMI and other standards developing organizations. That’s why many in the medical device industry rely on Leo Eisner of Eisner Safety Consultants to provide them with detailed reports on what is happening with all these changes.

If you want to stay up with the currently and in process medical electrical equipment and system (MEE&S) standards and home use MEE&S standards and technical reports before they are published or while in development to help with their regulatory strategy it is always helpful to know what is coming up in the near to long term. Also, it is good to know what has been published too as new titles don’t always get into standard update services clients get from standards sales houses because those are not being monitored yet.

These reports are based on the Annual Standards Committee Meetings plus all Leo’s standard committee involvement.  Leo was at the Kobe meeting in Japan Nov 2015 and this report covers what are the future plans for many of those Standards & Technical Reports including:

1) IEC 60601 series of standards on Electrical Medical Equipment and Systems (status update on changes in process),

2) Draft IEC/TR 60601-4-2  Electromagnetic immunity Guidance & interpretations,

3) IEC/TR 60601-4-3 interpretations of IEC 60601-1, Ed. 3.0 & 3.1 (I am on this Working Group),

4) Draft IEC 62366-2 Guidance on the application of usability,

5) IEC/ISO /TR 80001-X-Y series on Application of risk management for IT-networks incorporating medical devices,

6) Draft IEC 82304-1, ed. 1.0 Health software – Part 1: General requirements for product safety,

7) IEC 62304, Ed. 2.0 – Software Lifecycle Process,

8) Draft IEC/TR 60601-4-1 Guidance and interpretation – Medical electrical equipment and medical electrical systems employing a degree of autonomy,

9) Draft IEC/TR 60601-4-4 Guidance for writers of particular standards on creating alarm system related requirements (Not even on the official IEC Work Program as of March 15, 2016 but being on these committees I get a birds eye view of what is going on and I have direct links with lots of the committees I am not directly on as well),

10) US Version of IEC 60601-1-11 on home healthcare environment for Medical Electrical Equipment and Systems,

11) Draft of US Version of IEC 60601-1-12 on Emergency medical services environment for Medical Electrical Equipment and Systems,

12) Draft AAMI TIR75, Factors to Consider When Multi-Vendor Devices Interact Via an Electronic Interface, (Proposed new Technical Information Report),

13) IEC 62366-1, Edition 1.0 Medical devices – Part 1: Application of usability engineering to medical devices, and how FDA is dealing with this and the older version of the standard,

14) etc…

Other area of Interest in the report include:

1) Some regulatory impacts of some of the standards in the report like what is FDA expecting on IEC 60601-1-2:2014 (4th ed vs 3rd ed)

2) Harmonization roadblock issues for the EN 60601 series and how best approach it.

This should give you a flavor of the reports.  I also provide listings of the TC62, SC62A & 62D (some 62B & 62C) Committees for Electrical Medical Devices for IEC & EN standards & technical reports that have been issued in the last year or so and drafts of EN standards close to publication (not Harmonized just EN).

For the Home Use Report I have 13 pages of information on the Committees that focus on Home Use for the US and also for IEC (new Systems Committee for Active Assisted Living) plus lot of additional information.

These reports will be ready for release by the end of March or early April 2016. Cost $3,500* (US$) per report or for both of them just $6,500** (US$).  This is steal compared the time I socked into each one of these reports, the meetings I sat in on for 2 weeks in Nov in Japan (Kobe & Tokyo) in Nov 2015, and also the money saved not having to be on the committees, the travel expenses for getting to the meetings,  the time in the meetings, and the expected contribution to the standards development for being in these committees.  That is a lot of man hours that you get inexpensively from my hard work.

Contact us to purchase a copy of these reports now. Leo@EisnerSafety.com or call us at 503-244-6151.

* Current & past Eisner Safety Consultants Clients are eligible for a bigger discount if you purchase one of the reports.  To see the current discount go to the specialized services webpage for more details and for payment terms.  Please contact us to arrange for this special discount.

** Current & past Eisner Safety Consultants Clients are eligible for a bigger discount if you purchase both of the reports.  To see the current discount go to the specialized services webpage for more details and for payment terms.  Please contact us to arrange for this special discount.

We have teamed up with greenlight.guru, a specialized electronic Quality Management System (eQMS) platform specifically designed for small to mid-size Medical Device companies. greenlight.guru will reduce your quality management system overhead, a web based system, which is easy and practical to use, will minimize your paper trail, and consequently your need for excessive consultant hours allowing you to focus on your product and getting to market. greenlight.guru and Eisner Safety Consultants are both well equipped with our specialized expertise and know how to get your device to market, and more importantly – STAY in market!

Standards are absolutely critical when you are developing a medical device.

You need to understand why these standards are important when developing your product for your regulatory submission. You need to know what they are and understanding how to incorporate them as part of your design and development process at the beginning rather at the end.

Listen Now:

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“Your indications for intended use [of your device] are directly impacted by the markets where you plan for your product to be used.” –Jon Speer

In the Podcast Leo & Jon discuss:

• How Leo’s career in standards began
• Why standards are important
• Why should I care about standards regarding my medical device
• Standard IEC-60601
• Standards Reconnaissance Database
• Benefits of standards
• Updates to standards
• Classifying your product, drafting a test plan, checking against standards

“The most important reason you should care about standards is because of your regulatory submissions and your design process.” – Leo Eisner

A vital recommendation I tell my clients: When it comes to standards you need to know your product well enough to determine what standards apply early in the development process – from there you’ll know how much preparation and testing it will take.  If this is something you don’t have the expertise or the bandwidth for we can do it for you in several ways.  We can provide you with a tailored list of standards based on your product line(s), or you can sign up for our specially designed Standards Reconnaissance Database to help you navigate the standards that apply to you.

About The Global Medical Device Podcast:
The Global Medical Device Podcast powered by greenlight.guru is where today’s brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world’s leading medical device experts and companies.

Like this episode? Subscribe today on iTunes, Sticher or SoundCloud.

Does your Medical Device Regulator or your Quality System require that you maintain a list of applicable standards to meet these requirements for your product lines?  How much time does it take to put this list together and how much effort does it take to keep the list updated? If this is a struggle for your organization to keep up with all the different data sources we have the solution for you at a reasonable price. A Standards Reconnaissance Subscription Service to help medical electrical device manufacturers keep up to date on all the changes that occur for these documents so you are prepared for future changes well ahead of the norm and you are able to stay up to date on your list of standards. The focus of this service will be on the documents for medical electrical equipment & systems (MEE&S = IEC TC 62, SC 62A – 62D) and home use medical electrical equipment & systems (Home Use MEE&S = IEC Active Assisted Living System Committee (IEC AAL SyC) and any other Home Use medical electrical equipment documents from the IEC TC 62, SC 62A – 62D including IEC 60601-1-11 Home Use Environment).

We plan to go live with the db by the end of Sept 2015.

Please reserve your spot by September 28, 2015 for this db subscription service.

Some of the features will include [For Paid Subscribers unless noted otherwise]:

• Notification e-mails when changes occur (i.e. Change in transition information from FDA for a standard) and new records are entered into the db.
• Receive either 2 or 4 reports per year (depending on Subscription level) summarizing:
  • key issues of that report cycle for MEE&S or home Use MEE&S,
  • estimated timeline for the publication of draft standards & other relevant documents of significance, and
  • full listing of all the documents in your part of the db with status information.
• Access to our searchable db (depending on Subscription level access to the either the MEE&S or Home Use MEE&S part of the db or the whole db) on our dedicated db website if you are a paid subscriber. [Limited access for free level of service with 10 – 15 standards (pre-defined)]
• Print out db search results the way you want them
• Export db search results for your use (limited by the terms & conditions of the db)

There are several parts of this db [For Paid Subscribers unless noted otherwise]:

• Standards db – including information on the standards, technical reports, technical specifications, and publicly available specifications that are active or current, in draft or development which would include voting level documents such as New Work Proposals, Committee Drafts, etc., and withdrawn documents (The previous version of the active standard).
• List of standards publishers & associated country (this will cover 50+ countries) [includes free service level],
• List of Medical Device Regulators with their websites, if available, for a selection of countries including all the of EU & EFTA countries.  We plan to expand this to include all countries in the world by the end of Stage 2 (below),
• Guidance Documents – Guidance documents that the regulatory bodies use for their national regulatory systems. Like for the US, Canada, & Europe. They will be added sometime after going live by end of stage 2 or 3 (see below).

Once the db goes live you can check out how the db works by accessing the free level of service to view a few examples of current standards (about 10 to 15). With the free service level you will be able to use most of the db features set other than obtaining reports, the update notification service, but you will not have access to List of Medical Device Regulators db of Guidance documents db.

Pricing starts at only:

• $4,500/year for Base Entry Subscription (2 reports per year and select either MEE&S or Home Use MEE&S part of db),
• $6,500/year for Mid-Level Subscription (4 reports per year and full access to db), or
• $9,000/year & up for Premium Subscription (2 personalized reports for your company’s needs based on conversations with Leo Eisner, 2 reports per year from the Premium Subscription level, and full access to db)
  All payments to be paid in US$ only.

We plan to go live with the db by the end of Sept 2015. Since we will be releasing the db in stages the early adopters will get a discount (20%) for the first annual subscription cycle and additionally we will throw in extra months to your subscription commensurate with how early you subscribe.  The earlier you subscribe the more free months will be added to your first yearly subscription for no additional charge.

Please reserve your spot by September 28, 2015 for this db subscription service and to guarantee a discounted first year price and to obtain extra months added for free. To reserve your spot for the Base entry or the Mid-Level Subscriptions please arrange a $750.00 (US$) deposit and for the Premium Subscriptions please arrange a $1,500.00 (US$) deposit. Contact us to arrange for deposit.

There will be a couple stages for the release of information for the db.  We plan on continual updates over time to provide a really valuable resource and continually make it better. The first stage will be complete prior to the official release of the db which will include all the updated information for the IEC based MEE&S & Home Use MEE&S documents including updates on the small number of joint IEC/ISO documents.  Stage 2 will be initiated just before the release of the db, which will include updates for the US, EU, and Canadian versions of the IEC & IEC/ISO MEE&S and Home Use MEE&S documents and IEC/ISO joint documents. We plan to have stage 2 completed around Jan 2016.  Stage 3 will include updated information adding in the supporting medical device (non-medical-electrical) documents you need for your regulatory submissions such as ISO 10993 series of standards, ISO 15223-1, etc.  This stage will initiate with the non-medical-electrical standards for IEC and ISO and in the future we will add other Standards Developers.  We expect to start on stage 3 around Jan 2016 and have not yet scheduled it’s completion.

Please contact Leo Eisner to find out more details about this db. He can be reached by e-mail or phone at Leo@EisnerSafety.com and 503-244-6151 (Office) and 503-709-8328 (Cell).

If you are reading this post my guess is you already know the proposed MDD regulations are contentious and that there is some major changes proposed some good and some not so good. 

The later occurred a couple weeks ago when the Rapporteur Mrs. Roth-Behrendt proposed in a draft report for the MDD regulations.  As Eucomed states “The draft report is a step backward for patients, healthcare systems and Europe.”  The reason is the report calls for “a shift towards a centralised pre-market authorisation system which if carried through to the final legal text will confront patient in Europe with unnecessary delays of lifesaving medical devices reaching them without improving safety.”  The system would create a “enormous bureaucratic system with no benefits.”   Note, this is not a final report so there is a ways to go before we know if this will be finalized as is or modified. 

To get more information and perspective from these organizations please read on the posts and articles: Erik Vollebregt excellent article on the draft report detailing what the changes are; a Guest blog post on Erik Vollebregt medicaldeviceslegal website titled “no enhanced patient safety resulting from rapporteur Roth-Behrendt’s proposal”; Eucomed’s position and understanding of the Rapporteur ‘s draft report; a blog post by the CEO of MedTech Europe, EDMA, & Eucomed in regard to draft report for the MDD; MedTech Europe story on “European Parliament’s ENVI Committee releases draft reports on MDD and IVDD; and Where the EU system for medical devices is and needs to go.

We hope these articles help you understand where the process stands and help you form your own opinions.  From there where you go is up to you but know we will keep sending you updates on this process as we find relevant information to pass on as this process is critical to the survival of the European Medical Device Market.

We have decided to send out a monthly update of our blog posts for each month which are all located at www.EisnerSafety.com/Industry_News/.  We have been working out the bugs for the last few weeks and we are ready to go live as of today, 31 July 2012 evening (Some may receive your copy on 1 August).  If you haven’t viewed our blog posts in the last several months there have been some significant posts covering a lot of issues around national implementation of IEC 60601-1, 3rd edition (Japan, article on US, Canada, EU & Brazil) and Amendment 1 (just released); EU Competent Authorities formed Central Management Committee (CMC) for medical device sector & Issued Four Decisions; and much more.  You can also view our posts on Twitter at our Twitter feed at http://Twitter,com/EisnerSafety/.

If you would like to sign up for our newsletter please go to any of our webpages and enter the info in the upper left hand corner where it says “Sign-up to our newsletter”.

Do you have any feedback on the new monthly newsletters please feel free to let us know your thoughts on topics you would like to see in future posts or other suggestions are gladly welcome.  Send e-mail to info@EisnerSafety.com.