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NB-MED issues V1.1 FAQ on Implementation of EN60601-1:2006 w.r.t. MDD

6 Feb 2012 – The NB-MED EN60601-1:2006 issues team released their first official version (V1.1) of this important implementation document in regards to EN 60601-1 with respect to the Medical Device Directive 93/42/EEC (primarily written for this directive) and also the Active Implantable Medical Device Directive 90/385/EC (refer to Q & A 3.3.1).  This project started back in the Spring of 2011 (refer to pg 2 of document to see a good History of the process and the reasoning for this valuable resource).  

I (as a medical device consultant, US TAG member of IEC SC 62A & 62D & Convener of SC62D JWG9 {IEC/ISO/AAMI/CENELEC 80601-2-58} and a Notified Body Auditor) am really pleased to see the extremely hard work that has gone into this document and also in the value that it will pass on to all the stakeholders.  There are many stakeholders that were involved in this process including Notified Bodies, NB-MED EN 60601-1:2006 issues team (Thank you for your hard work.), NB-MED, Manufacturers, OEMs, Power Supply Manufacturers, Standards Developers for EN & IEC & other national standards bodies, Test Houses, Consultants, other countries regulatory bodies (i.e. FDA, Health Canada, etc.) and more.  By use of so many different stakeholders that submitted some of these and other questions this document has a much more consistent view on the implementation issues with the complexity of a series of more than 60+ EN 60601 standards.  It is expected that this document will get revised again but when that will happen is not clear at this time.  I would assume once Amendment 1 (A1) to EN / IEC 60601-1:2006 / 2005 is released approximately end of 2012 / Sept 2012 there will be more implementation questions in addition to the ones in section 3.9 (Q & A 3.9.1 thru 3.9.5 related to A1) of this excellent resource.

This document is good for learning about your specific implementation issue(s) or if you have the time I would highly recommend reading the whole document, as this will help you understand the intricacies of some of the situations of implementing EN 60601-1 with respect to the MDD (I’m sure there are more issues but a good portion have been captured by this first version).  I believe this document would be of great help to implement similar guidance documents for many other national medical device regulatory agencies around the world that are transitioning to the 3rd edition of IEC 60601-1:2005 (or their national version of the standard).

The Table of Contents gives a good glimpse into the realm of the issues covered in this document and covers the following topics.  I also provide a further glimpse into the document by summarizing some of the specific issues within those sections (these are the indents furthest to the right):

  • History (background of how we got to this point and document)
  • Introduction (Section 1 – document intended to clarify many questions as related to implementation of EN 60601-1:2006 within the EU under the MDD)
  • Abbreviations (Section 2)
  • Questions and Answers (Section 3 – Primary purpose of the document)
    • Process how to place products on the EU market (Section 3.1)
      • Explain ‘placing med dvc on the market’ in EU; If med dvc doesn’t change, regulation hasn’t changed, why need provide different evidence with new Harmonized Std; are harmonized stds mandatory; do you have to retest to 3rd ed, when product been on the market for years;  why bother with transition date 1 June 2012 when my EC certificate has a 2014 expiration date; does the product in a distribution center equal ‘placed on the market’; Medical Electrical Equipment(MEE)  met 2nd ed. & breaks down after transition period what std applies now for replacement MEE; why does EU require 3rd ed. compliance with new & legacy products;

    • Transition process in general (Section 3.2)
      • Is use of newest Harmonized stds even if product hasn’t changed after transition date; Would it have been better to have all the stds in the 60601 series have the same transition period; Is there the bandwidth for all the testing that will be required by the EN 60601-1:2006 deadline of 1 June 2012 (for only 3rd ed. without particular stds) that it may hit a critical point;
    • Application of EN 60601-1 (Section 3.3)
      • Does EN 60601-1:2006 apply to AIMD products; Are mechanical rqrts of 3rd ed. applicable to non-active products; power supply questions – external pwr supply compliant to 2nd ed., pwr supply approved against EN 60950 (ITE equipment), pwr supply part of a complete 2nd ed. compliant medical electrical equipment, my pwr supply mfr isn’t ready for 3rd ed. yet – my options; What do if applying to several countries and the other country(ies) requires 2nd ed. vs 3rd ed. in EU; EN 62304 in relation to 3rd ed. of EN 60601-1; software development issues; if for some reason major redesign needed to meet 3rd ed. are there smart ways to deal with this; how obtain test protocol TRF version G of 3rd ed.; is there a 3rd ed. delta list available for evaluation of an approved 2nd ed. product
    • Role of collateral standards (Section 3.4)
      • Are Harmonized Standards binding; what happens to collateral stds (i.e. EN 60601-1-XX) that have been integrated into 3rd ed. of 60601-1; how deal with collateral stds that don’t have an edition aligned with 2nd ed. of EN 60601-1 (i.e. EN 60601-1-11 & -1-12)
    • Role of particular standards (multiple or late particulars) (Section 3.5)
      •  multiple stds related to x-ray; if x-ray equipment has interventional & non-interventional procedures do both EN 60601-2-43 & -2-54 apply; some particular stds that don’t references 3rd ed. of 60601-1 what happens then; is compliance with 3rd ed. required after 1 June 2012 even if part 2 std won’t be released til after transition period; how deal with EN 13544-1:2007 + A1:2009 which is aligned with 2nd ed. of EN 60601-1 and currently there is no development of a 2nd ed. of EN 13544-1; van every kind of IEC or ISO std act as a particular std
    • Transition period of EN 60601-1:2006 (Section 3.6)
      • Should there be a 3 year transition period for brand new particular standards Harmonized per the Directive {i.e. EN 60601-2-XX}; particular stds with a transition period ending after 1 June 2012; transition date known for EN 60601-2-49; transition issues with EN 60601-2-43; how deal with EN 60601-2-2 & -2-10 which have different transition dates
    • Duties of Notified Bodies (Section 3.7)
      • ZLG paper 3.5 A1; How an N.B. audit of technical file or design dossier of product that hasn’t started the process, or plan set-up but not start testing, or partially start testing
    • Application of Risk Management (Section 3.8)
      •  What are the different roles of the applicable stakeholders in this process including the mfr., Notified Body, test house, etc.; equivalent safety (clause 4.5 of 60601-1 3rd ed.); how to deal with the differences between EN 14971:2001 (equivalent to ISO 14971:2000) and EN 14971:2007; mapping rev. G of TRF  for IEC 60601-1:2005 with Risk Management documentation that is required per EN 60601-1:2006
    • Amendment 1 related questions (Section 3.9)
      • Amendment 1 of 3rd edition of IEC & EN 60601-1 will be published approximately Sept 2012 & around end of 2012.  This is a major amendment with more than 100 changes some very minor and some that will mean more work for the manufacturers to prove compliance and some changes that will benefit the manufacturer.  It is recommended to review the A1 as soon as you can get your hands on it to see what type of impact it will have on you.
  • References (Section 4)
  • Recommendation for usage (Section 5)
  • Applicability of horizontal and role of particular standards (multiple or late particulars) for use in combination with IEC/EN 60601-1, 3rd.ed with respect to X-ray equipment (Annex 1)
    • General – applicability of standards (Annex 1, section 1)
    • Categorization of X-ray equipment related to its intended use and applicable standards (status 2012-01-20) (Annex 1, Section 2)
    • Summary (Annex 1, Section 3)
Click on the weblink to see the draft document that we posted on our website 6 Oct 2011.  To see the posting please go to http://wwww.EisnerSafety.com/draft-results-implementation-of-3ed-en60601-series-for-ce-marking/ and https://www.eisnersafety.com/eu-en-iec60601-1-3rd-ed-request-for-issues-on-the-use-of-the-std-for-ce-conformity/ for the first announcement about this process which we posted on our website on 24 June 2011 .