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).

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.
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  • key issues of that report cycle for MEE&S or home Use MEE&S,
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  • 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).

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

So, you can get to the important areas for you I have split this blog into several sections that you can jump too quickly by clicking on the below links:

• When did the IEC 60601-1 A1 come out?
• What is the status of the EN 60601-1 A1?
• Is EN 60601-1:06 + A1:13 Harmonized under the MDD Yet?
• What about all the other EN 60601 series of standards?
• So, what is Annex ZA about?
• And what about Annex ZZ?

When did the IEC 60601-1 A1 come out?

Amendment 1 (A1) of IEC 60601-1:2005 (3^rd ed.) was published last summer on 13 July 2013 and the consolidated edition (edition 3.1 = IEC 60601-1:2005 + A1:2012) was published on 20 August 2012.  The consolidated edition is very useful as it shows all the redlines of the 496 changes that were made for A1 vs the original 3^rd ed.

What is the status of the EN 60601-1 A1?

So, for Europe it has taken over a year to get the EN (European Norm) of A1:2013 to EN 60601-1:2006 (third edition) to be ratified by CENELEC which was on 24 Sept 20013, then it became available for publication (Date of Availability) in Europe on 4 October 2013 and so now it is allowed to be published in Europe and must be implemented or published by all of the EU countries by 24 June 2014.  The only country that I have been able to find it published in is Denmark as a Dansk Standard (DS or in English it would be Danish Standards).  It is DS/EN 60601-1:06/A1:13 issued on 15 October 2013.

Is EN 60601-1:06 + A1:13 Harmonized under the MDD Yet?

The answer is a no, not yet but we are getting pretty close to it occurring.   It hasn’t been Harmonized yet but soon it will be approved as a Harmonized Standard.  This document tells a lot of the story for the history of the Harmonization process for EN 60601-1:06 + A1:13.  This version of the standard has been reviewed and approved for harmonization by the Consultants so its only a matter of publishing it in the Official Journal of the EU (OJ).

What about all the other EN 60601 series of standards?

If you read thru the document referenced in the previous paragraph you will find there are 41 total 60601 series standards in the pipeline that are all expected to flood out of the OJ as Harmonized Standards under the MDD by the end of the 1^st quarter of 2014.  That’s a lot of change to come in a short period of time.  But realize that is not the full series of 60601 standard out there & note there are Joint IEC/ISO projects that are titled 80601 series too.  So, keep your eyes and ears peeled and open to keep up with what will be happening soon.

So, what is Annex ZA about?

Annex ZA is a listing of normative (required or mandated) references to international publications with their corresponding European publications.  This is a list of the European & EU Harmonized standards.  This primarily changes most of the IEC and ISO standards that are referenced in IEC 60601-1:06 + A1:13 (ed. 3.1) to EN & EN ISO standards for the EN version of the standard.  The standards that change in the base of the standard are marked by (mod.) to indicate the original requirements have been modified by common modifications as noted in the beginning of Annex ZA.  There are some that stay as IEC & ISO standards but most change.  But that isn’t the bombshell.  When A1:12 of IEC 60601-1:05 was published a decision was made to go from dated references for the IEC 60601 series standards (i.e. IEC 60601-1-2:2007) to primarily undated references (IEC 60601-1-2), unless a specific standard reference didn’t meet the criteria for the change (most changes occurred and a few stayed as dated references).  The primary reason for this change was to make the standards development maintenance process of the whole series of standards (almost 60 standards in the series & growing) easier to update when there was a change in a Particular (i.e. IEC 60601-2-XX) or a Collateral standard (i.e. IEC 60601-1-XX).  About a year ago under the IEC A1 version of 60601-1 undated references came about but that now has been changed back to dated references in the EN version of the standard (EN60601-1:06 +A1:13).  This means, as it says at the beginning of Annex ZA, “For dated references, only the (dated) edition cited applies.”  Annex ZA also says “For undated references, the latest edition of the referenced document (including any amendments) applies.”

So, for the IEC series of 60601 standards you currently have the Collaterals and Particulars being updated or will be updated in the near future (now thru about 2 years from now) to reflect the undated standards references to filter through-out the whole series of IEC 60601 standards.  So, more change to keep an eye out for.  Some people would say you need to have a Master’s degree to keep up with this but you could rely on consultants, like me, as this is one of my many job duties is to keep up-to-date on standards development information so I can keep my client’s informed & up-to-date.

And what about Annex ZZ?

Annex ZZ is a fairly long section clocking in at 19 pages long and part of the focus is on the Risk Management Process of sub-clause 4.2.2 of EN 60601-1:06 + A1:13 as the EN ISO 14971:2012 standard is the Harmonized standard most recently called out in the EU MDD Harmonized List of Standards (a voluntary listing but easiest way to prove compliance too) and is a significant modification of ISO 14971:2007 with some major changes to it.  So read on for more details with respect to the changes for risk management, among other issues for this Annex ZZ.

Annex ZZ is titled the “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices”. Annex ZZ is a means for showing conformance to meeting the parts of the Essential Requirements (ER’s), Annex I, of the MDD under 93/42/EEC as amended by 2007/47/EC, that apply to the standard EN 60601-1:06 + A1:13.  This standard doesn’t confer compliance with all of the ER’s under the MDD only certain ER’s in whole or in part.  I am repeating the first page text of Annex ZZ in “quotes” below and then writing my commentary, in italics, to explain each section.

“This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association to provide a means of conforming to the Essential Requirements given in Annex I of the EC Directives 93/42/EEC as amended by 2007/47/EC.”

This means that EN 60601-1:06 + A1:13 Annex ZZ will be the means to prove conformance to the ER’s of the MDD in whole or part based on a mandate to CENELEC from the European Commission & EFTA.

“Once this standard will be cited in the Official Journal of the European Union under that Directive, compliance with the clauses of this standard given in Table ZZ.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements (ERs) of that Directive and associated EFTA regulations.”

Once this standard is Harmonized under the MDD (via publication thru the OJEU) compliance with the clauses of the standard, within the limits of the scope of the standard, cited in Table ZZ.1 confers a presumption of conformity with the corresponding ER’s of the MDD & associated EFTA regulations (MDD adopted by EFTA). 

 “NOTE 1     This standard is intended to be applied in its entirety only. Selected clauses or subclauses may be not applicable due to the specific type of equipment under consideration. It is necessary to understand and apply Clauses 1 to 5. It is also recommended to understand and apply those clauses which contain general requirements related to a specific subclause. Elements of the standard that are not cited in Table ZZ.1 may be relevant for the appropriate fulfilment of certain essential requirements through indirect reference, and for safety and performance aspects of the device, that are not addressed through essential requirements.”

You must use the whole standard.  You can’t just pick and choose clauses you need the whole enchilada otherwise not a valid evaluation of the product.  But you may be able to cite & provide justification that certain clauses & sub-clauses don’t apply to your specific device.  Clauses 1 thru 5 of the standard must be applied and understood completely and well.  These clauses include the scope of the standard, the object, how the Particular and Collateral standards of the 60601 series of standards apply, which standards are normative references and how they work (dated vs undated), terminology & definitions, general requirements which includes discussion of & requirements for:

• Conditions of the equipment to be tested and analyzed
• The Risk Management Process
• Essential Performance
• Expected Service Life
• Equivalent Safety
• Parts that touch the Patient but aren’t to be marked as Applied Parts
• Single Fault Condition
• Component requirements
• Use of High-Integrity Components
• Power Supply issues

And General Requirements for Testing the ME Equipment

• Type Tests
• Number of Samples for testing
• Environmental issues
• Test conditions
• Repairs and modifications
• Humidity preconditioning
• Sequence of tests
• Determination of Applied Parts vs Accessible Parts

 Also, all clauses that apply general requirements related to specific sub-clauses must be considered & addressed.  Even if there are specific sub-clauses that aren’t cited in the Table ZZ.1 that doesn’t mean they aren’t valid to help meet some of the ER’s even if indirectly & for safety & performance aspects of the device, not addressed through the ER’s.

“NOTE 2     Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance to the MDD (Directive 93/42/EEC amended by 2007/47/EC). This means that risks have to be reduced “as far as possible”, “to a minimum”, “to the lowest possible level”, “minimized” or “removed”, according to the wording of the corresponding essential requirement.”

Where there is a reference made from a clause of the standard EN 60601-1:06 + A1:13 to the risk management process, the risk management process needs to be in compliance with the MDD.  This means that risks have to be reduced according to the specific wording of the corresponding ER.  Such as with the wording “as far as possible”, “to a minimum”, etc.

“NOTE 3     With respect to note 4 of clause 4.2.2 General requirement for risk management, the manufacturer’s policy for determining acceptable risk must be in compliance with essential requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the directive.”

Note 4 of clause 4.2.2 “General requirement for risk management” states:

“NOTE 4     Where requirements of this standard refer to freedom from unacceptable RISK, acceptability or unacceptability of this RISK is determined by the MANUFACTURER in accordance with the MANUFACTURER’S policy for determining acceptable RISK.” 

This infers that the standard IEC 60601-1:05 + A1:12 requires that Risk is determined by the Manufacturer’s policy for determining acceptable risk which is the Risk Management Process under ISO 14971:2007 per the IEC standard (ed. 3.1) but once you get into the MDD & EN Harmonized standard it will be EN ISO 14971:2012 based on the conversion done in Annex ZA.

So, continuing on — Risk is determined by the Manufacturer’s policy for determining acceptable risk which is the Risk Management Process under EN ISO 14971:2012 for the ER’s 1, 2, 5, 6, 7, 8, 9, 11 & 12 of the MDD.  When you look at Table ZZ.1 you will see in a greyed out area of the top of each ER section for ER’s 1, 2, 5, 6, 7, 8, 9, 11 & 12 there is a note that says “General Guidance note 2 and 3 shall be observed” which infers that you need to follow the risk management process stated in these specific ER’s per EN ISO 14971:2012 Annex ZA (for the MDD) which is where all the modifications of the Risk Management standard were made by the EU Commission causing total havoc for the EN ISO version of the standard even though not in the main text of the standard Annex ZA has caused a total mess of what was once a specific standard and now has been jumbled and makes it hard to meet risk management requirements for multiple countries when one of them is the EU and there are other countries involved as ISO 14971 & EN ISO 14971 are in direct conflict with each other.  You can meet one but not both at the same time from what I have surmised.

“NOTE 4     References in the clauses 3 to 17 or in the Annexes of this standard specify whether the normative references listed in Clause 2 as cited in Annex ZA are to be applied in whole or in part.”

Clauses 3 to 17 (the meat of the standard) and the Annexes of the standard EN 60601-1:06 + A1:13 specify whether the mandatory (normative) references listed in Clause 2 (the clause for all the Normative References of the standard), which in the EN version of the standard is replaced by the citations in Annex ZA for clause 2, are to be applied in whole (the whole standard) or in part (a certain portion of the standard) as noted in the standard itself.  

“NOTE 5     This Annex ZZ is based on Normative References according to Annex ZA, replacing the references in the core text.”

Annex ZZ of this EN 60601-1:06 + A1:13 standard is based on the Normative references of Annex ZA (Normative Standards that were replaced from IEC & ISO standards to the European EN, EN ISO, & HD standards in the EN 60601-1:06 + A1:13 version of the standard).  Bottom line this means that all the IEC 60601-1:05 + A1:12 normative references are to be replaced by the Annex ZA normative standards references for the EN 60601-1:06 + A1:13 version of the standard.

“WARNING: Other requirements and other EU Directives and Regulations may be applicable to the product(s) falling within the scope of this standard.”

This simply means that the MDD is not the only Directive that may apply.  Some examples of Directives and Regulations that may apply include the following examples:

• Restriction of Hazardous Substances (RoHS2) Directive 
• This is coming up for most medical device manufacturers in June of 2014.  That’s not a lot of time to get ready for this process.  If you would like to learn more about this process for the medical device manufacturer please join me in a presentation on RoHS2 for the Medical Device Industry on 17 Dec 2013.
• Waste of Electrical and Electronic Equipment (WEEE) Directive
• Machinery Directive
• Radio and Telecommunications Terminal Equipment (R&TTE) Directive
• Privacy / data protection Clinical data and other personal data Directive
• Regulation on electronic instructions for use of medical devices
• Etc.

Note, that Axon Lawyers has prepared a document for their local RAPS group on the associated Directives that may apply to your EU medical devices and they have been generous to allow all of us to have access to it.  So, thank you Erik Vollebregt for one of your many resources that has helped my clients and I to understand better the implication of the Warning in Annex ZZ of EN 60601-1:06 + A1:13. 

So, get a copy of the standard EN 60601-1:06 + A1:13 so you can have access to the important Annex ZA and Annex ZZ.   If you follow the details noted there you should be in good shape. Annex ZZ is a useful tool to make it easier to know what ERs are applicable to the 60601-1 standard and what is expected instead of doing it blindly for so many years without that support. Last week I actually used this table in Annex ZZ very successfully to audit a MDD Technical Files ER checklist and it provided a wealth of information that just made my life a lot easier and will make yours a lot easier too if you need to put an ER Checklist together for your next Technical File or for a Design Dossier too.

I remember when first working on the IEC based standard that I am a convener of (IEC/ISO 80601-2-58) I was requested to work on the parallel EN standard.  Someone in our Joint Working Group (JWG) suggested that we (the JWG) put together an Annex ZZ but I was later told by some in Europe the 60601 series of standards wasn’t doing that yet because of some political issues that I was never clear on. So, I guess we finally broke that cycle, many years later, and now many of the 60601 series of standards are slated to go thru this process (41 thru the end of 1^st quarter of 2014). I think at first probably the more popular ones will get processed and who knows how long it will take to get all of them processed thru.

If your company needs help with edition 3.0 or 3.1 for EN or IEC 60601-1 gap analysis, preparation of the risk management file for these versions of the standard, or training on the Standard, please contact Leo Eisner at: Leo@EisnerSafety.com.

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This could have a huge impact on the EU market place including the patients, medical device manufacturers (especially the smaller medical device companies), and put jobs at risk, as well.  See the article from Eucamed on a survey they did of medical device companies in Europe to get an idea of the costs involved with these proposed changes.  On 25 Sept 2013 Eucamed said they expressed “…disappointment and strong concern at the outcome of a vote in the European Parliament’s Committee for Environment, Public Health and Food Safety (ENVI)….” in their Article titled Rushed deal leaves patient and jobs in second place.

There are several sources I rely on a regular basis to keep up to date on this changing landscape and the next two websites are some of my favorite blogs as they have very reliable information that is on point, sometimes they will even make a predication here or there (with decent odds of being right, but not always) and always helpful for the medical device manufacturer.

The first of the 2 websites I read regularly is Medical Device Academy.  The article provides analysis and interpretation of how the EU took the next step in approving the proposed medical device regulations. This article covers a lot of ground including the EU Commission Press Release about two new documents in relation to Notified Bodies, Eucamed’s Political Positioning, Next Steps in the Proposed Medical Device Regulations Approval Process (important to read), and lastly Why is there a Rush?

The second website I am always checking up on is MedicalDeviceslegal written by a lawyer that works at a boutique life sciences law firm Axon Lawyers located in the Netherlands who is able to keep a really good pulse of the industry and the development of these types of regulations, laws, directives, and such.  He has written many articles on this specific subject and has been following the process closely.  His latest article indicates that the “ENVI vote result worst of all worlds”.   He gives you the bad news straight up.

Other resources I rely on a pretty regular basis that also have articles on this subject are: 

• RAPS Regulatory Focus which has 2 articles for today 26 Sept 2013 on the subject:
• European Parliament Passes Landmark Medical Device, IVD Reform Proposals
• European Commission Strengthens Oversight of CE-Marking Process
• MASS DEVICE article I saw today on the topic but with other related articles from other days:
• EU panel approves FDA-like requirements for medical devices
• Fierce Medical Devices one article I saw today but with other related articles from other times:
• EU committee backs tougher, U.S.-style device approval system

We also set-up pages to do the same for checking on the status of the IEC 80601 series of current & draft standards, which are standards that are jointly developed between IEC & ISO, and TRFs of the current 806012 series standards.  These later standards are called either IEC 80601-X-Y standards or ISO 80601-X-Y standards.  The lead organization gets their organization initials in the standards identifier.

This is a great resource to be able to stay up to date on the standards that are being developed, the updates to current standards and to ensure your standards library is up to date as required under ISO 13485 and also under most medical device regulatory national schemes.  If your organization needs help keeping track of current &/or developing standards our organization can help you develop a system or we can do this work for your organization’s standards and external documents library.  Please feel free to contact us about this at Leo@EisnerSafety.com or 503-244-6151.

MEDDEV 2.12-1 Guidelines on a Medical Devices Vigilance System was updated in January 2013.  The revised guidance is applicable as of July 2013.   The revision contains clarifications rather than significant changes.

Download the MEDDEV 2.12/1 revision 8 Guidelines on a Medical Device Vigilance System effective July 2013.  An unofficial Comparison of MEDDEV 2.12/1 from revision 7 to revision 8 can be downloaded, as well. 

Changes include:

• Clarification that, in addition to IVD’s, indirect harm can be from:
  • diagnostic devices,
  • consequence of the treatment of cells (e.g. gametes and embryos in the case of IVF/ART devices) or organs outside of the human body that will later be transferred to a patient, or
  • software qualified as medical devices (e.g., incorrect information generated by software).
• Reinforcement that, when there is doubt, a report should be submitted.
• Clarification that, regardless of how a lack of performance to labeled specifications is identified (field report, in-house testing, etc.), if the issue might lead to or might have led to death or serious deterioration in the state of health associated with the use of the device and the issue impacts a product that has already been placed on the market then a field safety correct action (FSCA) must be initiated.
• Adds “absence of treatment” as an indirect harm that must be considered.
• Indicates that a National Competent Authority should consult the manufacturer or the manufacturer’s European Representative before forwarding a National Competent Authority Report (NCAR) to fellow National Competent Authorities.
• Updates to reporting formats from the MEDDEV website are below in the formats that they provide them in:

Manufacturer Incident Report(971 KB) 
How to use the MIR(13 KB) 
Field Safety Corrective Action(2 MB) 
Trend Report(151 KB) 
Periodic Summary Report(192 KB) 
MIR and FSCA xml files(2 MB)  

Actions to consider:

• Review your MEDDEV procedure(s) to ensure that:
  • Any source of indirect harm will be considered and, if such could result in harm, will result in submission of an incident report.
  • Actions taken to reduce risk of death or serious deterioration in the state of health associated with the use of a device that is already placed on the market will be reported through a Field Safety Corrective Action Report.
  • “Absence of treatment” is an indirect harm that will be considered when making a reporting decision.
  • Where there is doubt, a report will be submitted.
  • Referenced forms reflect the current versions and requirements for completion.
• Review the contract with your European Representative to ensure that it is clear on how the company expects the EU Rep to respond to a request for comment on a NCAR.

Many thanks to Helene Spencer to highlighting the new revision (and for indicating that, with a little work, it is possible to create an unofficial redline).

If you need assistance with this or other issues, please contact us at Leo@EisnerSafety.com.  As a reminder, you can access a full list of MEDDEV’s from the MEDDEV guidance website .

The EU Commission has advised that the disappearance of EN 980 was a mistake and it is still Harmonized and will be corrected at the next release of the updated Harmonized Standards Listing, hopefully in the next few months.   The EU Commission didn’t Harmonize the EN ISO 15223-1 because they saw issues in relation to the Directives (MDD, AIMDD, & IVDD) and Annex Z’s (e.g. Annex ZA, ZB, ZC) of the standard EN ISO 15223-1:2012.  Because the standard EN ISO 15223-1 wasn’t Harmonized under this last round by the EU Commission CEN extended the date of withdrawal of EN ISO 15223-1:2012 from Jan 31, ‘13 to Jul 1, ’15.

For access to the current list of Harmonized Standards, published Jan 24, ’13, they are available thru our previous post FDA & EU MDD / AIMDD / IVDD Updated Standards Lists.

Christine Ruther, an Eisner Safety Consultants Associate reminded us

“The directives already allows the use of symbols from non-harmonized standards with the stipulation that the symbols and colours must be described in the documentation supplied with the device (e.g., MDD Annex I item 13.2).  As most manufacturers define all symbols, regardless of origin, this gap in a harmonized standard for symbols should not be an issue.

In any event, manufacturers are expected to take a common sense approach to managing the situation.  This will likely entail writing a short quality plan that acknowledges the situation and defines what actions will be taken.  Actions might include waiting for the next update of harmonized standards to confirm which standards are harmonized, reviewing existing use of symbols to confirm compliance with EN ISO 15223-1 in anticipation of the change, or other actions.”  NOTE: It is not clear, at this point, if the EU Commission will Harmonize EN ISO 15223-1:2012 for the next publication of the List of Harmonized Standards for the MDD, AIMDD, & IVDD.

For Christine’s part of this post we should also thank NSAI for forwarding information on this momentary vacuum.

If you are interested in the IEC 60601 Series of Standards for Medical Electrical Equipment (MEE) and Medical Electrical Systems (MES), this is the group that will allow you to share your experiences, ask questions and discuss your opinions. This is a platform for 60601 experts, and those that want to learn more, to discuss topics related to this large set of standards related to MEE & MES including 7 Collateral Standards (and counting) and over 60+ Particular Standards. In addition to these Particular Standards, there are many other standards that apply to MEE & MES. 

This series of standards is very important in the medical device regulatory world as the IEC 60601 series of standards are the “Gold” standard for national regulatory agencies such as the FDA, Health Canada, The EU Medical Device Directives (MDD & AIMDD), the Japanese Ministry of Health, Labour & Welfare (MHLW), and many other national regulators. Most countries adopt these standards into their national standards mostly without modification but on occasion national deviations are needed to meet the national electrical code among many other issues. 

This group is here to discuss a wide range of topics related to the IEC 60601 series of standards, the regulatory impact of these standards (such as the differences in 3rd ed. vs 2nd ed. of IEC 60601-1 & country specific regulatory impacts), the changes continually happening in this field (i.e. 3rd ed. of IEC 60601-1, IEC 60601-1, 3rd ed. + Amendment 1, etc.), what are the regulatory requirements for specific countries as they evolve (like in the Middle East & Asia), and many more topics within the medical device world are also up for play.

The group is run by Leo Eisner of Eisner Safety Consultants, an expert in the IEC 60601 series of standards, and the group is owned by IEC.  Please come and join us in this new adventure and see what you can bring to this new group and/or learn from your group members.

* NOTE:  The IEC is the owner of this LinkedIn sub-group under their main umbrella IEC LinkedIn Group.  Leo Eisner is the manager of the group and if you have any questions with regard to the IEC 60601 series of standards on Medical Electrical Equipment Sub-Group please contact Leo.

First a closing statement press release from the GHTF president was issued recently (dated Nov 2012) and on the International Medical Device Regulators Forum (IMDRF) webpage for the Archived GHTF documents there is a statement at the top of that page stating:

• “Important! The organisation GHTF no longer exists, and has been permanently replaced by the IMDRF. All material appearing on this page and the pages within has been moved here from the old GHTF site for preservation, and is no longer current. It is historic information and should not be acted upon.”

Another point to note is that the last set of documents from the GHTF were issued on 2 Nov 2012 and the IMDRF website in the last couple days seems to have been totally updated and reorganized in an easy to use format that will make it easy for the public to view this valuable resource and to stay up to date on the happenings of this organization.   Hopefully,  in the next decade, or sooner, the IMDRF will begin the process of Harmonizing areas of the international medical device regulatory arena so medical device manufacturers won’t have to deal with varying regulations through out the world.

On the Archived GHTF webpage it also states that they have brought all of the current and archived GHTF documents over to the IMDRF website.  Note, that the GHTF website is still up but it is not clear what will happen to it or when it will be taken down.

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More about the IMDRF: Straight from the IMDRF website the following gives you some information about the organization.  If you have furhter questions about the organization please contact the IMDRF secretariat at imdrf.secretariat@tga.gov.au

IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence.

IMDRF was born in October 2011, when representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and the United States, as well as the World Health Organization (WHO) met in Ottawa to address the establishment and operation of this new Forum. A copy of the outcome statement from this meeting is available from the Meetings page.

Further information about the work and operations of IMDRF is available in its Terms of Reference (Note, the last page of this document has an organizational chart showing the roles and inte-relations of these roles).

On the About Us webpage  they go on to describe the different roles and responsibilities within the IMDRF.   The functions described are the IMDRF Management Committee; the Management Committee Members (Australia, Brazil, Canada, Europe (the EU), Japan, and the USA);  Official Observers (World Health Organization {WHO}); Affiliate Organizations; and Working Groups.

RAPS Regulatory Focus Article posted 30 Oct 2013 on the subject is interesting and provides some additional background and perspective.