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.

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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/.

ANVISA (The Brazil National Health Surveillance Agency) issued the rule IN 4 on September 24, 2015  (that superseded the IN 11, dated December 16, 2014) which requires the standard ABNT NBR IEC 60601-1:2010 + Emenda IEC:2012 – the Portuguese translation of IEC 60601-1:2005 + Amendment 1:2012 (Edition 3.1 or 3rd edition + Amendment 1).  This standard is required for any new product seeking ANVISA approval since September 24, 2015 and going forward.

Before we get to the 60601-1-9 issue let’s talk a little about which version of 60601-1 applies.  If you have an INMETRO certificate that met 60601-1 3rd ed. you are ok until you have to rectify your product or your certificate expires.  If the Particular Standard 60601-2-XX  is still based on the 2nd ed. of 60601-1 then you still can use the 2nd edition of 60601-1.  But check the IN 4 before you move forward that way to make sure you are using the proper version of the applicable standards.  For the EMC standard you only need to deal with the 60601-1-2 3rd ed. which is equivalent to the 2007 edition of IEC 60601-1-2 and is the less stringent standard compared to 4th ed of 60601-1-2.

Along with 60601-1 there were a long list of other 60601 based standards in the Notice including the 60601-1-9 standard for “environmentally conscious design of medical electrical equipment”.  If you would like a copy of this notice please e-mail me at Leo@EisnerSafety.com.  I believe that Brazil is the first country that is mandating the use of 60601-1-9 . The full IEC standard title is “IEC 60601-1-9:2007 + Amendment 1:2013 Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design“.  The Brazilian version of the standard is ABNT NBR IEC 60601-1-9:2014 which is translated into Portuguese and the text is identical to IEC 60601-1-9:2007 + A1:2013.

ANVISA is requiring compliance to the standard by December 1, 2016 specifically for the clauses 4.1, 4.5.2 and 4.5.3 of the standard.  So, the documentation needed will include the identification of environmental aspects (clause 4.1), instructions for minimizing environmental impact during normal use (clause 4.5.2), and information for end of life management (clause 4.5.3). 

If you need help with IEC 60601-1, any in the Series of Standards or any National Version of these standards please email Leo Eisner at Leo@EisnerSafety.com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants.