A reminder that FDA Guidances and Recognized Consensus Standards are voluntary.  But I remind my clients’ that if you don’t use these voluntary documents for premarket submissions you make your life and the reviewer’s life a lot harder, typically.  So, I recommend, in most cases, to use these voluntary documents to speed up the process, in the long run.  In the short run, you may need to do more testing but if you don’t you risk the chance of your product not being accepted by the FDA.

The Guidance goes on to say that “the review of EMC information in a submission is based on the risk associated with EMC malfunction or degradation of the device under review, as well as the use of appropriate FDA-recognized standards or appropriate consensus standards.”  The Guidance indicates that manufacturers typically reference in premarket submissions Recognized consesnsus national (US) and international standards such as IEC 60601-1-2²) (3rd or 4th edition) Medical Electrical Equipment EMC standard, device specific Particular Standards such as IEC 60601-2-XX, and lastly they reference other consensus standards for electrically-powered deevices that include information on EMC such as ISO 14708³ for active implantable medical devices.

The Guidance continues with a listing of details that FDA is expecting manufacturer’s provide in their premarket submissions, so the medical device EMC information is clear and consistent information for the submission, and are consistent with the specifications included in the standards, as referenced above, that are applied to the premarket submission.  The Guidance points to the FDA Recognized Consensus Standards database located at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

The rest of the Guidance, Section II “EMC Information”, details the list of items the FDA is expecting of the manufacturer’s for premarket submissions.  And of course the FDA leaves an opening for a broad statement at the end of the section that says: “Additional information not outlined above may be requested by FDA depending on intended use and intended use environment for specific active medical devices (e.g. implantable portions of active devices) to demonstrate the device’s claims regarding electromagnetic compatibility (EMC).”

If you need help with this FDA Draft Guidance or with IEC 60601-1-2 edition 3 or edition 4 or you are interested in our new Eisner Safety Consultants Standards Reconnaissance Database please email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

^{Footnotes cited from FDA Draft Guidance Document issued on 2 Nov 2015 titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”}

<sup>1. According to International definitions, “disturbance” is the cause and “interference” is the effect. In the US, “interference” is often used interchangeably for both cause and effect though more often for the cause. 
2. IEC 60601-1-2: 2007 [3rd Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests, IEC 60601-1-2:2014 [4th Ed.], Medical Electrical Equipment, Part 1 2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests, AAMI/ANSI/IEC 60601-1-2: 2007 [3rd Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests, and AAMI/ANSI/IEC 60601-1-2: 2014 [4th Ed.]:Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests 
3. ISO 14708-3 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators</sup>

Compliance to standards has become a key part of regulatory requirements. Due to move towards Global Harmonization of regulations, it has become important not only for the developed markets of US, EU, etc. but also the emerging markets (e.g. China, Brazil, etc.)

Our new service helps you identify the required standards and editions for your intended markets.                                                                   

Our service helps medical electrical device manufacturers (our specific focus of our database) keep up to date on new standards, updates to existing standards, and draft standards under development. This assures you can plan ahead of any major changes.

We reduce your burden on this time consuming task, so you can focus on what you are good at – developing products.

We do this at very reasonable rates.  We are offering to early adopters an extra discount on the price and extra time (3 months) will be added to the first year subscription. 

See our demo page for the types of reports we generate for the service. Find out more about the service.

We decided to take a little extra time to capture the large amount of information involved.. We will be Live by Mid Oct 2015.

Sign-up now for a live release notification and you will receive a special limited time offer that no one else will receive after we go live!! If you would also like to receive our Eisner Safety Consultants Newsletter sign-up here. Also, early adopters get an extra discount on the price and will get an additional 3 months added to their first year subscription if you sign-up in time.

What does the Service Provide:

The service includes several databases:

1. The Standards database is the primary focus. It includes standards, technical reports, technical specifications and guides. It includes new documents, updates to existing documents, as well as drafts under development (e.g. New Work Proposals, Committee Drafts, etc.)
2. List of standards publishers and the associated country.
3. List of Medical Device Regulators and their websites (if available).
4. Guidance Documents related to the standards for key markets. [Coming Soon]

A periodic report** is provided as part of the service.

All paid subscribers will have the ability to:

• Run searches of subscribed databases
• Print out search results from displayed data
• Print out tables of results in tabular format
• Export data for generation of your own reports (based on terms of service)
• Multiple user log-in for your company (limited to 5 unique user log-ins)

Discount for Initial release: We are releasing the database in stages, the early adopters (Current stage – stage 1) will get a discount (20%) for the first annual subscription cycle and an additional 3 months added to their subscription if you sign-up in time.

Sign-up now to receive a live release notification and you will receive a special limited time offer that no one else will receive after we go live!! If you would also like to receive our Eisner Safety Consultants Newsletter sign-up here.

Stage 2 will add Guidance Documents for the US, Canada, and EU. Also, list of standards publishers and the associated country will be expanded to cover 50+ countries. Stage 2 will be released by early 2016.

Stage 3 will expand the standards database to include US, EU, and Canadian versions of the IEC standards & IEC/ISO joint documents. It will also expand the regulators information and their websites beyond the key markets. Stage 3 will be released early Spring 2016.

Stage 4 will expand the standards database to include the supporting (non-electrical) medical standards used for your regulatory submissions e.g. ISO 10993 series, ISO 15223-1, etc. Stage 4 will be released early Fall 2016.

View details on the Subscription Levels

Please feel free to contact me with any questions you may have. I can be reached by e-mail or phone at Leo@EisnerSafety.com and 503-244-6151 (Office) and 503-709-8328 (Cell).

The old MDD Harmonized Standards Listing used to be located at the website address of http://bit.ly/MDD_Harmonized_Stds_Listing but as of 2 Feb 2015 the site has been archived.  The new site can be found by following the instructions on the archived site.  First click on the link in the bright yellow band on the top of the old site titled “Internal Market, Industry, Entrepreneurship and SMEs website“, then on the new page that opens click on the “Single Market and Standards” link, then on the left hand bar select the link titled “European Standards“, then on the next web page select the link on the left hand bar titled “Harmonised Standards“. Then search for the section titled “Healthcare engineering” and select the applicable medical device directive you are looking for:

• Medical devices (MDD)
• Active implantable medical devices (AIMDD)
• In vitro diagnostic medical devices (IVDD)

If you need help with your EU CE for the Mark Medical Device Directive, the Active Implantable Medical Device Directive or the IVD Directive, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants). 

The standard IEC 60601-2-52 is at the 1st edition + Amendment 1 as an FDIS.  The voting period is from 12 December 2014 thru 13 February 2015.  It should be published as an IS if the vote is positive shortly after (forecasted to be published on 27 March 2015).

A1 changes include:

• Added definition of sub-clause 201.3.219 of an Adult and appropriate places through out the standard.  Note the definition of an adults in this standard is at least 146 cm (57.48 inches  = 4 ft & 9.48 inches) in length, at least a mass of 40 kg (88.18 lbs), and a body mass index of at least 17 (this is on the upper end of the under weight category but goes up to the high end of obese > 40 bmi).
• Added a requirement that hazards related to Patients taller than 185 cm should be considered in the Risk Management. (Sub-clause 201.4.2)
• Updated the Entrapment test tool of figure 201.103a) & b).
• Added a new symbol required to mark on a medical bed to identify what the requirements for the “adult” using the medical bed are.  (Sub-clause 201.7.2.2.107) The symbol is to be placed on the medical bed in a prominent location and is to identify what an adult is, as defined in the standard in sub-clause 201.3.219.

• Added a requirement for the ifu to include a description of the intended Patient group(s). (Sub-clause 201.7.9.2.1e))
• Added a requirement that if the medical bed is limited to a specific group of patients to id that in the ifu. (Sub-clause 201.7.9.2.2e))
• Added a waning needs to be added to the ifu that incompatible side rails and mattresses can cause an entrapment hazard. (Sub-clause 201.7.9.2.2f))
• Updated figures 201.107 & 201.108 for medical beds with single or split/segmented side rails.
• Added a note related to sub-clause 201.9.8.3.2 on “static forces due to loading from persons” that support assemblies used in this test may be allowed to use a lower safety factor.
• Updated the Particular guidance and rationale section to incorporate “Adult” into this section of the standard for the Scope & Adult Definition.  (Annex AA, Section AA.2, Sub-clause 201.1.1 & definition 201.3.201)
• Added to Annex AA, Section AA.2 Guidance & Rationale for Sub-clause 201.4.2 a list of possible hazards of medical beds to consider.
• Delete a paragraph in Annex AA, Section AA.2, Sub-clause 201.9.101 – Protection against inadvertent falls.

Just released as of June 25, 2014 this NBRG Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971:2012 is finally available.  Be forewarned that the document is not yet adopted by the NBRG, which can only be done at the next Meeting in October 2014.  Hopefully it will be adopted at that meeting.  I will check in with my NBRG Risk Management Working Group contacts to find out if they know more about that issue.

But let’s take this chance to review a little about the document and the history of the EN ISO 14971:2012 Annex Z’s.  Future posts will get into more details. The following 3 paragraphs come straight from the introduction of the document as the Working Group summarizes the situation really well.  I happen to know a couple of these working group members personally and I know they have a very good handle on the situation and they have provided some very good background.  

In October 2010, the regular review of ISO 14971:2007 which is the basis of EN ISO 14971:2009 was closed by a broad majority of votes confirming the existing status and the wide-spread acceptance of this standard in the medical devices community, including competent authorities. In November 2010, the European Commission raised a formal objection against the use of several harmonized standards, including EN ISO 14971, followed by an in-depth assessment of the coverage of the Essential Requirements of the Medical Device Directives (90/385/EEC, 93/42/EEC and 98/79/EC) by these standards.

As a result of these objections, the Annexes Z to EN ISO 14971 were modified, resulting in EN ISO 14971:2012. This amendment of the EN ISO 14971 standard did not modify the normative parts of ISO 14971:20071. The Annexes Z describe the extent of presumption of conformity that can be based on application of the normative requirements of ISO 14971 alone. The “content deviations”, expressed in the revised Annexes Z, between ISO 14971:2007 and the Medical Device Directives have been commented by many experts in the field of risk management and resulted in diverging interpretations from different stakeholders (e.g. manufacturers, notified bodies, competent authorities).

This document has been prepared as a Notified Body Consensus Paper by a working group headed by the NBRG Vice Chair, with representatives from several European Notified Bodies and industry associations COCIR, Eucomed, EDMA and ZVEI. The paper aims to provide a practical interpretation of these “content deviations” to the Medical Device Directives and give guidance as to how to implement the risk management requirements. The work consolidates prior publications of various sources and is intended to facilitate common understanding between industry and Notified Bodies.

If you would like further info on the consensus document and some history please check out the previous posts below (Latest to Oldest):

• MD&DI Article “Collaboration Holds the Key to Clarity on EN ISO 14971:2012”

• NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation 

• NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012

This post discusses that EN60601-1:2006+Amendment 1 (A1):2013 has finally been Harmonized under the MDD.

This is really big news that many of us in the medical industry have been waiting to hear occur for quite awhile.

What’s The Big News About?

On 16 May 2014 the Official Journal of the European Union (OJEU) published an updated Harmonized Standards List for the MDD 93/42/EEC (2014/C 149/02), therefore making it a Harmonized Standard under the MDD.  Of the five changes to the list for “first publication” documents the one of concern for this post is EN 60601-1:2006 + A1:2013 (it is also known as Edition 3.1 which means 3rd edition of EN 60601-1 [published 2006] + Amendment 1 (or A1) [published 2013]).  The cessation of presumption of conformity for the EN 60601-1:2006 (3rd edition without A1) has been set to be 31 December 2017 ( a 3 year transition period) but there is more to the picture so please read on otherwise you will run into a problem before that date.

Remember That Harmonized Standards Are Voluntary:

NOTE: A reminder that EU Harmonized Standards are not mandatory to meet the Essential Requirements of the MDD but do help make it easier to meet the Directive than going it without the use of Harmonized Standards typically but it is your choice how to approach this issue. I do recommend, to my clients, that they use Harmonized Standards, when they can, since they are common standards that Notified Bodies and Test Houses understand and are familiar with.  So, it is easier to use a Harmonized Standard like EN 60601-1 than to prove, with a higher burden of proof, using a different standard(s) or internal specification(s), etc. that the Notified Bodies may not be as familiar with and then the manufacturer has a higher bar to prove to the Notified Body to prove they meet the Essential Requirements of the MDD.

What’s That Note All About?

In the recently released OJEU Harmonized Standards Listing for EN60601-1:2006+A1:2013 there is an extensive note that discusses the dates of cessation which reads verbatim:

“Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006. The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31.12.2017. However the Annex ZZ to EN 60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 93/42/EEC on 31.12.2015. As from 1.1.2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 93/42/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013.”

What’s The Bottom Line?

So, what does the above text really mean?  You will need to consider the A1 Annex ZZ before the end of the transition period for the standard EN60601-1:2006 (3rd edition).  The EN60601-1:2006 transition period ends on 31 December 2017 but on 1 January 2016 you will need to comply, if using this voluntary standard, with the clauses of Annex ZZ of EN60601-1:2006+A1:2013 to be provided with the presumption of conformity that is needed to help meet the essential requirements of the EU Directive in relation to the EN60601-1 standard.  

To learn more about the Annex ZZ refer to the 2nd post in the below listing of past posts on the 60601-1 standard.

How Many Changes Are There in A1:2013 of EN 60601-1:2006 + A1:2013?

There are quite a few changes in A1 as there are 496 changes that were brought into the standard.  Why so many changes?  The original 3rd edition of the standard was released before it may have been totally ready but after about 10 years of development the standard committee decided they needed to get something out before the project would have been sent back to the drawing board (meaning it could have taken another couple years to release it) by IEC rules and also because at that point there was so much anticipation of the release by industry and the Test Houses the standard committee decided it was mature enough to get it out the door.  Of the 496 changes only about 70 of the changes are moderate to significant impact and the rest are editorial and minor corrections including typo corrections too.

For easy reference we have listed below some of our past posts on 60601-1 and 3rd edition + A1 which may be of interest to you.

1. Q&A on OSHA NRTL for AAMI ES 60601-1 3rd ed. + A1
2. Status Update on EN 60601-1:06 + A1:13 for EU MDD & Annexes ZA & ZZ
3. FDA Extends AAMI ES 60601-1 Transition Date to 31 Dec ’13 & Other Important Changes – Recognition Lists 031/032
4. IEC TR 62348:2012 Added in Assessment of impact of most significant changes of IEC 60601-1:2005 Amendment 1 (This Technical Report  talks about the significant and moderate changes to the standard of the 496 changes that were made to the standard.) 
5. When will IEC 60601-1:05+A1:12 turn into EN Standard?
6. IEC 60601-1:2012 Consolidated 3.1 Edition Just Published
7. Amendment 1 of IEC 60601-1:05 (3rd edition) has been published by IEC

This post is a status update on the NBRG RMWG Risk Management Consensus Document

30 April 2014 – The NBRG (Notified Body Recommendation Group) Risk Management Working Group (RMWG) membership will have a face to face meeting in mid May to refine the draft Consensus document on EN ISO 14971:2012.  This meeting has come about because the NBRG RMWG received some feedback recently from the EU Commission and they will consider it and roll it into this document.

The consensus document’s purpose is to reduce the confusion around the EU Harmonized Standard EN ISO 14971:2012 Annexes ZA, ZB, & ZC that amends the EN ISO 14971:2009 version of the standard to align with the 3 Medical Devices Directives (the Medical Device, Active Implantable Medical Device, and In Vitro Diagnostic Medical Devices Directives). The previous plan was to have this Consensus document completed and released by Mid to Late April ’14 but at this point it is hoped the NBRG RMWG will have a final released document by the end of June 2014. We look forward to sending good news about the progress of this document over the next month or so.

If you would like further info on the consensus document and some history please check out the previous posts below (Latest to Oldest):

• MD&DI Article “Collaboration Holds the Key to Clarity on EN ISO 14971:2012”
• NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation
• NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012

The NBRG (Notified Body Recommendation Group) Risk Management Working Group is working to put together a consensus document.  A call to industry has been sent out to ask for participation in a survey on how your risk management system aligns with EN ISO 14971:2012 that will help in the direction of this consensus document so please take part in it.  Read the article for more details and a post that links to the survey.

Past posts on this subject include:

• NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation
• NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012

If you need help with Risk Management with respect to the IEC 60601 series of Standards, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

The live link to the survey is on the fourth set of pages on slide deck and is slide 8 of the presentation.  The more participants in the survey the more likely your voices will be heard and we hope this will improve the potential outcome of the process.

On 8 February we posted the NBRG letter which was a Call for Industry Participation in the Survey on Understanding Annex Z of EN ISO 14971:2012. 

[slideshare id=32021997&doc=mdmwestpresentationonnbrgconsensusdocumentoneniso14971201211feb2014-140306235842-phpapp01&type=d]

On 7 February 2014 the Vice Chair of the Notified Body Recommendation Group, Michael Bothe, sent out a letter to industry to ask for their participation in a short survey (about 10 minutes long) to help the Notified Bodies understand what are industry’s current practices when it comes to conducting Risk Management Process on their medical devices and IVD’s and how it relates to EN ISO 14971:2012.  As the letter says it is to “attempt to develop a practical interpretation on how to use and implement Risk Management in the context of the European Medical Devices Directives, more specifically the European version of ISO 14971:2007, as published in EN ISO 14971:2012.”

Please join in on this survey, as the more participation the more representative the data will be to the Notified Bodies and hopefully this will make for a better Consensus Document on EN ISO 14971:2012 Risk Management Process.  Please complete your survey responses by 21 March 2014.

To find out more about what is going on with this proposed Consensus Document please join me, Leo Eisner as the track chair for Improving Risk Management Strategies and Procedures, at the MD&M West conference on Tuesday 11 February 2014, as I discuss how we got to this point and what is hopefully going to culminate in a Consensus Document on Risk Management with regard to EN ISO 14971:2012.

If you have questions about this topic or need help with compliance with your Medical products you can e-mail Leo Eisner at Leo@EisnerSafety.com directly or call Leo at 503-244-6151.  Leo is the Principal Consultant of Eisner Safety Consultants.