Do you have EU transition period questions related to the MDD & AIMDD Harmonized Standard EN IEC 60601-1:2006 (or sometimes known as 3rd edition of EN IEC 60601-1), its’ collaterals (EN IEC60601-1-XX) and its’ particulars (EN IEC 60601-2-XX) standards? If you do, you have until June 30th, 2011 to submit your questions to an expert team, at , that will endeavor to answer these questions by September 30, 2011 for this 1st round of this new group. Please read the below letter that have been sent to many different places around the world but note the only questions that will be answered are not the technical issues of how to apply 3rd ed. of EN IEC 60601-1 or even any transitional questions in regard to the FDA (ANSI/AAMI/ES 60601-1), Health Canada (CAN/CSA C22.2 No. 60601:08), MHLW (Japan), or SFDA (China) but only with respect to the implementation of EN IEC 60601-1, 3rd edition in regard to CE Marking under the MDD and AIMDD. Several years ago there was a FAQ document issued that was on the older version of the CENELEC website when the site changed that link disappeared. Only just before this letter (below) was issued about the submission of additional transitional questions with regard to 3rd edition of EN IEC 60601-1 did this FAQ document show up again on the CENELEC website in the Medical Equipment Technology Sector. This FAQ document is an excellent primer for understanding some of the transitional issues for 3rd ed of EN IEC 60601-1 with respect to the MDD & AIMDD. With this group hopefully collecting additional transition issues the FAQ document will grow and improve our overall understanding of some of the challenges with the transition of EN IEC 60601-1 3rd edition and its’ 60 or so related standards.
I would like to also thank Martin Schneeberg & Peter Linders for allowing me to share this with all my clients and website visitors.
Implementation of EN IEC 60601-1 3rd edition
Request for Issues
on the use of the standard for CE-conformity purposes
When the transition period was defined for EN IEC 60601-1:2006 (replacing the 1988 version with its two amendments), several questions arose. These questions were included in a FAQ document that was posted at the CENELEC web site (click here) to give all users the same interpretation[1]: (click here).
The transition period, after which only the 2006 edition will be giving presumption of conformity with the relevant Essential Requirements of the Medical Device Directive (93/42/EC), is now well underway. As an increasing number of manufacturers are implementing this version of the standard, more questions come up. In particular this is the case in conversations between manufacturers and involved authorities or Notified Bodies considering CE-conformity purposes.
In an attempt to support these discussions, and to harmonize responses, we are looking for specific matters that have arisen and that may have wider relevance. Together with regulatory experts, we will seek answers to those matters that reflect a consensus opinion of the Medical Notified Bodies. Clearly, this is not a request for technical matters, e.g., for required test conditions, but rather unclear situation. A few examples of such matters are given in the annex.
If you know of such matters, or even have experienced some yourselves, please share these. If you have reached agreement on these matters or you have proposals for the same, and wish to share: these are also very welcome. As indicated, the matters will be compiled and given to experts for sound advice, followed by scrutiny from NB-MED experts, resulting in the best available recommendations for the matters indicated. This advice will be made publicly available.
Please submit your contributions to: . Note that not all contributions may receive individual responses. We will start work with material submitted by 30 June 2011, yet contributions after that date remain welcome. We expect first results by 30 September.
Thank you for your consideration and valuable contributions.
Martin Schneeberg (TÜV SÜD PRODUCT SERVICE, member of UK 811.1, IEC TC62A, WG14, MT28, A1PMT, IECEE RM TF)
Wolfgang Leetz (Siemens AG, Healthcare Sector, chair of DKE Division 8 (electro medical equipment, electro acoustic, ultrasound, laser), chair of COCIR Standardization Policy Focus Group)
Peter Linders (Philips Healthcare, chair of CENELEC TC 62, chair of COCIR Technical and Regulatory Affairs Committee, member of IEC/TC 62 CAG, A1PMT)
Annex – Examples of questions sought
Q1. Valid EC Design-Examination certificate period vs. DOCOPOCOSS: 2012-06-01:
Example: Suppose an MDD class IIB or III electrical medical equipment was placed on the EEA in 2009. It has a signed EC Design-Examination Certificate by a NB based on 2Ed EN 60601-1, valid until 2014-01-01 (five years).
Question: Is this product affected by the DOCOPOCOSS related to EN 60601-1:1990 (+ am1 + am2), June 1st 2012? Keep in mind that a valid EC certificate has been issued by a NB which is valid 5 years up to 2014.
Q2. Future totally new particular standards:
For a specific MEE does not exist a specific particular standard related to 2Ed EN 60601-1. However, for this specific MEE a totally new particular standard related to the 3Ed EN 60601-1:2006 is work in progress. This question is relevant at least for:
– 60601-2-63: for dental extra-oral x-ray equipment,
– 60601-2-64: light ion accelerators,
– 60601-2-65: for dental intra-oral x-ray equipment,
– 60601-2-66: hearing aids and hearing systems
Officially such MEE’s shall fulfil the complete 3Ed EN 60601-1:2006 plus the relevant particular standard 60601-2-XY at the date 2012-06-01, unless there is a specific transition period for the applicable particular standard. Usually no specific transition period for the totally new particular standards are defined in the OJ, therefore, 2012-06-01 will apply.
Is there any guidance beyond the general advice to discuss specific problems related to the application of these new standards with the NB and using Risk Management?
Can 3 years transition period for the EN 60601-2-XY be claimed starting from publishing the EN version of the particular standard?
Q3. Is ZLG paper 3.5 A1 legally binding for EU NB’s and MEE manufacturers:
The ZLG-paper 3.5 A1 addresses a valid concern extremely clear: “The missing new assessment by the manufacturer after the end of the “doc” or the missing knowledge about the existing of new harmonized standards or scientific knowhow are substantial NON-conformities. If these NON-conformities will not be adequate corrected, the certificates have to be suspended or withdrawn.”
Is this paper legally binding? Am I allowed to ignore it? In clear words: If the “doc” is over and I have not objective evidence about the new 3Ed EN 60601-1:2006 requirements in a point-by-point protocol format, is my NB forced to suspend or withdraw my CE-certificate?
[1] Collateral standards under the MDD & AIMD: CLC/TC 62 questions and answers on the EN 60601-series of standards in relation to the MDD and AIMD