COMMISSION IMPLEMENTATION DECISION M/575 was issued 14 April 2021: This is a list of standards the EU Commission is hoping to Harmonize under MDR and IVDR.  One of the issues is the HAS consultant has issued a negative assessment on EN ISO 14971 which the CEN/CLC JTC3 leadership is working with the HAS consultant to address the issues and to draft acceptable European annexes so Harmonization can occur for the standard.  Many of the standards on the list in M/575 reference to EN ISO 14971 so it is highly likely that CEN and CENELEC will reject this newest version of the EU Commission Standardization Request again and we won’t have any Harmonized Standards by the Date of Application (26 May 2021) for the MDR which will cause lots of problems for manufacturers and Notified Bodies and cause more delays for the MDR & likely even for the IVDR I’m sorry to say.  Also, the MDCG 2021-5 “Guidance on standardisation for medical devices” doesn’t seem to clarify when harmonized standards are not published through the Offical Journal of the EU what to do.  In section 3.1 mentions Harmonized standards are voluntary with respect to the MDR & IVDR as they were for the MDD, AIMDD, & IVDD.  The closest the MDCG gets to it is to use the “State of Art” standards approach in section 3.5.

Another important observation is all the newest versions of the General & Collateral IEC 60601 Standards that were issued Summer of 2020 (EN versions were issued later in the year) are listed in Annex I of the EU Commission Standardization Request as the deadline to adopt these standards by 27 May 2024 — These are EN 60601-1, ed. 3.2; EN 60601-1-2, ed. 4.1; EN 60601-1-3, ed. 2.2; EN 60601-1-6, ed. 3.2; EN 60601-1-8, ed. 2.2; EN 60601-1-9, ed. 1.2; EN 60601-1-10, ed. 1.2; EN 60601-1-11, ed. 2.1; & EN 60601-1-12, ed. 1.1 – The Particular Standards EN 60601-2-XX or EN ISO 80601-2-XX listed are primarily based on the previous versions of the General & Collaterals of IEC 60601 standards on the M/575 list so this will likely cause conflicts vs the listed new standards mentioned here.

Follow the full discussion and updates to this post on LinkedIn

Confused this is what Eisner Safety Consultants experts deal with all the time for countries for these and many other standards, regulations, laws, directives, and more. Leo Eisner is an expert on standards development and sit on many standards committees. Let us help you through this process. Need help with Essential Performance. Feel free to schedule a call with Leo www.EisnerSafety.com/Schedule-Call/ or contact Leo at Leo@EisnerSafety.com or through our contact form at https://eisnersafety.com/contact_eisner_safety/.

A good summary article on IEC e-Tech News about the IEC 60601 Series Amendments project that published last summer (2020) the General 60601-1, and Collateral standards (60601-1-XX). Please note that you need to read further comments in some of my articles about IEC 60601-1 for IEC 62368-1 and IEC 60601-1-2 for some additional details. One blog post is an article from InCompliance

Essential Performance (EP) initially came into the IEC 60601 series of standards when the 3rd edition of IEC 60601-1:2005 was published. The definition was quite confusing and many manufacturers, regulators and test houses had a hard time with it and how to apply it properly. In 3rd edition (2005) + amendment 1 (2012) some clarification came into play which made it easier to understand but there is still a fair amount of confusion.

About 2 years ago a test lab did some research and brought up the issue that a significant number of test reports (a high percentage of them) of critical devices didn’t define essential performance appropriately to the Sub Committee SC62A on “Common aspects of electrical equipment used in medical practice”. From this research, an ad-hoc group was formed to come up with a solution.

The initial solution was to come up with this Interpretation Sheet (ISH) to explain Essential Performance (clause 4.3 which is not as clear as the ISH but for those that know the standard have been doing it this way for years) and Single Fault Condition (SFC) (clause 4.7) that is related to Essential Performance. Access a copy thru the IEC website if you know where to find it or the easier route is to download it here. Note, this document doesn’t cover all the issues about Essential Performance as it is a complex situation but it does help explain some of the issues involved. The ISH per IEC requirements is limited to 2 pages of written text of explanation allowed by IEC requirements and so has a constraint on how detailed it can get. It is good for explaining the concept for the General standard IEC 60601-1, edition 3.1 which covers also ed. 3.2 (no change there). The General standard concept is based on limits but for some Particular standards (IEC 60601-2-XX or IEC/ISO80601-2-XX), limits don’t work for all products applicable (not all display-based product that the clinical function is based on the display function for example). But the ISH doesn’t really get into the details of how EP deals with Particular standards much (covered a little in the ISH) so that really needs to be looked at further still.

So, what is the next step? This ad-hoc group with the help of some additional people in the standards development community (I hope to be in this group) will start in the next couple of months (probably after the IEC TC 62 General meeting of April 12 – 23, 2021) to work on a guidance document to provide further guidance on EP as I still find that many regulators around the world, test labs, and manufacturers all have varying understanding of what EP & SFC are.

This varying understanding has a huge impact on projects as if say the test lab asks the manufacturer what their EP is, the manufacturer may say I don’t have any, the test lab will check the test report form (TRF) as none. When gets to say FDA the first thing FDA would ask is why is there no EP on the device? If found out there is EP the client would have to retest under the applicable IEC 60601-1, Particular (60601-2-XX/80601-2-XX) and Collateral Standards (60601-1-XX) + the EM Disturbances standard IEC 60601-1-2 which would add cost and time delays to a project.

Need help with Essential Performance. Feel free to schedule a call with Leo www.EisnerSafety.com/Schedule-Call/ or contact Leo at Leo@EisnerSafety.com.

1 January 2019 is not far away and the 4th edition of the standard may have a significant impact on the design, testing and documentation of many medical devices that have not met this standard yet.  For the US (FDA), EU (CE Mark for Medical Devices), and Canada (Health Canada) this is the final transition date to meet this requirement.

When do we have to comply with IEC 60601-1-2 4^th edition?
The three countries/regions of the world (US, EU, & Canada) have synchronized the date of compliance to 1 January 2019.  This was not always the case as FDA modified their transition date several times before settling on this date.  Realize that most other countries are requiring 3rd edition and some are still back on 2nd edition of IEC 60601-1-2.  A brief summary by region is shown below:

USA – For new submissions to the FDA, compliance to the 4^th edition will be mandatory by January 1, 2019. The FDA now recognizes the 4^th edition and encourages manufactures to comply with the 4^th edition for new device submittals and this can be seen in the updated Final Guidance for Home Use Medical Devices that the FDA re-issued in November 24, 2014 and updated on August 8, 2016 to update the transition date of ANSI/AAMI/IEC 60601-1-2. During this transition period the FDA also will accept 3^rd edition of the standard as well up til December 31, 2018.

European Union – The Date of Withdrawal (DOW) which is the required compliance date of EN 60601-1-2:2014, is December 31, 2018.  The DOW date is the end of the grand fathering period for the previous version of the standard, EN 60601-1-2007 (third edition).  After that date, all devices including legacy devices sold to the EU must comply with the new standard.

Canada – In Health Canada’s List of Recognized Standards it states that until December 31, 2018 it will accept Declarations of Conformity to either 3rd or 4th edition of IEC 60601-1-2.  After which declarations of conformity to IEC 60601-1-2:2007 – Ed 3.0 will not be accepted.

Other Regions – The compliance dates are highly variable driven by other international standards and local regulations. For example, for a particular standard (Part 2 particular standards IEC 60601-2-XX or IEC/ISO 80601-2-XX) for a given device will most likely at this time reference IEC 60601-1-2, 4th edition if the country is using the most current IEC 60601-2-XX or IEC/ISO 80601-2-XX standard but otherwise may be referring to an older version of the IEC 60601-1-2.   Additionally, some countries will NOT accept the 4th edition at this time to further complicate this issue.

Please note that compliance dates of standards are driven by their national regulatory bodies (i.e. US = FDA, Canada = Health Canada, etc.) and are subject to change.

It is strongly recommended to comply with the requirements of IEC 60601-1-2 4^th edition for all new medical device designs going into the US, EU, and Canada.  You may still need to meet 3^rd edition, as well.  It really depends on what other countries you plan to sell too and your regulatory strategy.  We can help put a test plan and test strategy together to deal with testing to 3rd & 4th edition.

We have several EMC experts that can assist our clients with the transition to IEC 60601-1-2, 4^th edition as it is having a major impact on the design, testing and documentation required of most medical devices.  We are seeing signs of a new wave of projects related to IEC 60601-1-2, 4^th ed. and know that this edition will have a big impact on electrical medical devices.

The EMC services we can provide your medical device company are listed below, for your convenience, in addition to our other regulatory, product safety, engineering, and quality system consulting services.

EMC Services Available

• EMC Design – Review of PCB schematics & layouts, enclosure design, mechanical construction, internal and external cabling design, etc.
• Mitigations  – Problem analysis, prototype fixes, support design engineering on redesigns, EMC component vendor liaison, etc.
• EMC Witness Testing & Documentation – Perform testing oversight, generate test plans, review and generate test reports
  
• Risk Analysis – Work with the design and test teams to address Risk Management as required by IEC 60601-1-2 4^th edition
• EMC Standards – Guidance and interpretation of numerous EMC standards and regulations
• EMC Regulatory Engagement & Support – Provide support for FDA, FCC, Health Canada, KFDA, ANVISA, CE Mark and other agency approvals
• Medical Device EMC Labeling – Review accompanying documents for compliance to IEC/EN 60601-1-2 requirements
  
• Training – Training your staff on EMC design, testing, IEC 60601-1-2, 4^th edition, and differences between 3^rd and 4^th editions

Are you ready for these changes, do you have the bandwidth to deal with these changes?  We can help you with preparing for these changes and on your EMC regulatory strategy. Contact us at Leo at EisnerSafety dot com or call Leo at 503-245-6558 to arrange an EMC project to help support your medical electrical device EMC needs.

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>

From the EMC experts I work with I have heard that some of the test levels have changed significantly and so that will could impact your designs for future compliance testing.  So, a question that is currently unanswered is when will this standard be transitioned into national standards for different countries around the world.  The standard text suggests at least a three year transition period.  It will be up to the different national standards development organizations (SDO’s) and the regulatory bodies around the world to make those determinations.  We will be keeping close tabs on this and reporting any information we hear more.

The foreword of the standard mentions a list of most significant changes from the third edition to the current fourth edition of the standard which include:

– specification of IMMUNITY TEST LEVELS according to the environments of INTENDED USE, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the HOME HEALTHCARE ENVIRONMENT and SPECIAL ENVIRONMENTS;

– specification of tests and test levels to improve the safety of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS when PORTABLE RF communications equipment is used closer to the MEDICAL ELECTRICAL EQUIPMENT than was recommended based on the IMMUNITY TEST LEVELS that were specified in the third edition;

– specification of IMMUNITY tests and IMMUNITY TEST LEVELS according to the PORTS of the MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM;

– specification of IMMUNITY TEST LEVELS based on the reasonably foreseeable maximum level of ELECTROMAGNETIC DISTURBANCES in the environments of INTENDED USE, resulting in some IMMUNITY TEST LEVELS that are higher than in the previous edition; and

– better harmonization with the RISK concepts of BASIC SAFETY and ESSENTIAL PERFORMANCE, including deletion of the defined term “life-supporting”;

and the following additions:

– guidance for determination of IMMUNITY TEST LEVELS for SPECIAL ENVIRONMENTS;

– guidance for adjustment of IMMUNITY TEST LEVELS when special considerations of mitigations or INTENDED USE are applicable;

– guidance on RISK MANAGEMENT for BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to ELECTROMAGNETIC DISTURBANCES; and

– guidance on identification of IMMUNITY pass/fail criteria.

We will send out a more detailed post on this topic in the future.  Keep an eye out for an update post on this standard.

This issue we are going to focus on the 60601-1 series of standards based on the 3^rd edition of 60601-1 and the MDD & AIMDD, including the Amendment 2007/47/EC for the MDD.  First we are presenting an audio conference on the Marking and Labeling requirements for IEC 60601-1 which will be on November 18^th.  Please come and join in the audio conference.  Next we summarize the issues discussed on the CENELEC FAQ web page dealing with EN 60601-1, 3^rdedition questions that apply to the MDD and AIMDD.  Then we discuss the big changes coming down the line for the draft EMC Standards IEC 60601-1-2, 4^th edition & the new IEC 6XXXX, 1^stedition.  This is a must read article for any electrical medical device manufacturer.  Lastly, we remind you that there are less than 5 months left til the MDD Amendment requirements come into play.  One way to deal with this is to use our MDD Amendment Toolkit, which is only $249.00.

We hope you enjoy the third edition of our newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

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