Dan,
Thanks for clarifying! Yes, you are correct (that is what happens when in a rush to begin a long weekend...). All CEN standards are termed 'EN', but not all are harmonized. To be harmonized, there first needs to be a Standardization Request (mandate) from the European Commission to CEN/CENELEC. Then the annexes Z published in the standard, and finally a listing in the Official Journal of the European Union (OJEU).
In the example you cite, you are correct that the superseded version of EN ISO 11135 (2007) is listed in the OJEU. The draft amendment A1 has been published as ISO 11135:2014/Amd 1:2018 by ISO in 2018, but has still not been issued by CEN (hence the FprEN designation), which should not happen (publication should occur at the same time in CEN and ISO) as these documents are aligned under the Vienna Agreement.
You raise an interesting point regarding notified bodies. European standards when published, have a date of withdrawal (DoW) that is normally 6 months, but can be extended by CEN upon publication of the standard. This is the date that the new standard is in full force and the former version is declared obsolete. Regarding harmonization, generally the date of cessation of presumption of conformity will be the date of withdrawal. So it would be inappropriate to use a harmonized standard as such after it has been superseded (i.e. after the DoW). DoWs can be found by going to the CEN website www.cen.eu and clicking on search standards; type in the standard number, then click on the standard. The information will be displayed on the right. In the case of EN ISO 11135:2014, the DoW is July 31, 2017.
So I agree that there is some disconnect occurring here.
As far as the EU MDR/IVDR process is concerned, there is still not a Standardization Request (mandate) for these regulations; there have been several drafts published but to date, nothing published. So we cannot even begin to harmonize any standard against these regulations without the mandate being in place. There have been rumours that the European Commission will not harmonize standards under the existing MDD/IVDD due to workload, and this was compounded by a legal case (James Elliott Construction Ltd v Irish Asphalt Ltd) that ultimately went to the European Courts of Justice (ECJ), who handed down its judgement in 2016 to imply that a harmonized standard was a provision of EU law. My understanding here is that conformity to a harmonized standard could be used as a presumption of conformity (and of course within the scope of annex Z) to the cited directive or regulation's Essential Requirements (ERs) or General Safety and Performance Requires (GSPRs). This appeared to cause a halt to harmonization activities for a period of time.
As @Ludger Moeller stated, very interesting conversation!
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Lena Cordie-Bancroft
Victoria MN
United States
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Original Message:
Sent: 04-Jul-2019 10:49
From: Ary Saaman
Subject: ISO 13485-2016 VS EN ISO 13485-2016
I believe this whole concept of Harmonized Standards needs a complete make-over. The harmonization process is unbelievably slow for almost zero added value. Often, it comes in addition to an already time consuming process for creating or revising the corresponding international standards. To me, it looks more like Occupational Therapy ("Beschäftigungstherapie") than a meaningful contribution to ensuring the continued safety and effectiveness of our medical technologies. It is my guess that all or most EU Member States and affiliated countries (like Switzerland) have voting rights and possibly committee members in the major international standards organizations (say, IEC and ISO) and therefore know well in advance what is coming our way. My suggestion is that by default an international standard (at least the ones commonly used throughout our whole industry) becomes the European Harmonized Standard three months after its issuance, unless within that timeframe a Europeanized version (with its Annexes-Z) is published. In addition, it is anyway in our best interest to move on to the latest editions of these international standards as soon as possible, but with a practicable (doable) transition time. With kindest regards,
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Ary Saaman
Director, Regulatory Affairs
Lausanne
Switzerland
Original Message:
Sent: 04-Jul-2019 10:27
From: Ludger Moeller
Subject: ISO 13485-2016 VS EN ISO 13485-2016
Dear Anonymous, dear All,
What an interesting discussion! I would like to give this now a new spin in regards to the use of the harmonized standards for the compliance.
One aspect, which needs to be known about harmonized standard is the Annex Z. This Annex outlines the exact correlation to the law! The European market relies on harmonization and provides harmonization with the new approach regulations (MDD, MDR etc.), which try to provide a set of requirements (Annex I) but those are not specific on how to comply. The tool for compliance is supposed to be given by the harmonized standards (faster adoption of state-of-the-art solutions via the standard process then updating each time the law!). Therefore, they are essential for the whole system.
The Annex Z shall be very precise because they provide a presumption of conformity to the legal requirements (a few years back CEN and CENELEC were heavily criticized not doing a good job with that and therefore most likely need more time for the Annex Z today). Having stated that it needs to be noted that harmonized standards are not mandatory. However, compliance with the law is!!
Consequently, there are two aspects to consider:
- If there are no harmonized standard check what is available to get the state-of-the-art compliance with the law. If a harmonized standard is outdated then certainly the latest and greatest standard may or even should be selected. Your compliance checklist could outline where the new standard provides better compliance and this should be supported with your risk assessment! Also, if a number of aspects may not be covered by a given standard the same applies for those aspects (Article 10. 9 has requirements which are definitely not covered and will not be covered by the EN ISO 13485!)!
- Selecting not complying to a harmonized standard is very well possible. Notified Bodies (NB) are not allowed to make standards mandatory. However, not utilizing a harmonized standard may be difficult. Let's take the EN IEC 601 series as an example. These are safety standards and I guess if someone selects not to comply to it may blow up his risk assessment to the sky!! And the bad news is that a NB would have to check all of that! However, the good news is, if a particular requirement would prevent a greater benefit to the patient you have the freedom to deviate or ignore a standard or standard clause. Again, the risk analysis must be very good and it most likely would have to be clinically tested.
That currently harmonized standards are not available would not prevent to be in compliance with the law! The system is open for that. One solution is to utilize a good checklist comparing the old requirements (MDD) with the new ones (MDR) and identify what are the difference. Should you identify that a particular requirement indeed is the same then the solution adopted with the harmonized standard according to the MDD should be sufficient for the MDR requirement. The harmonization process most likely will not change the standard. The work is to get the Annex Z established, which in essence is a reference table. And if the standard is not changing then you certainly should be in compliance with the MDR for at least those aspects. Now for any new requirement the current harmonized standard may as well provide a solution. However, other option may be utilized and it is up to your QM and RM system to identify the right compliance solutions for your products.
The compliance document can be easily established but it is just a matter of time and certainly a good understanding of the requirements. MDSS GmbH provides such document to its clients for the Annex I comparing the MDD with the MDR. Simply contact us.
Anonymous, it would be great if you could let me know whether the above information was helpful for you.
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Ludger Moeller
President, MDSS GmbH
lmoeller@mdss.com
Original Message:
Sent: 04-Jul-2019 07:57
From: Edwin Bills
Subject: ISO 13485-2016 VS EN ISO 13485-2016
The EN prefix does NOT mean the standard iOS Harmonized. It only means one of the European standardization organizations, CEN (similar to ISO) or CENELEC (electrical standards like IEC) has approved a version of the standard. A standard must be published in the Official Journal of the EU to be Harmonized to a particular Directive or Regulation as cited in the publication. There is presently NO Harmonization process for the MDR / IVDR so no Harmonized Standards exist for these regulations. It likely that it will be some time before we see these new standards. All current standards will have to be revised to new version and submitted to the non-existent Harmonization process for consideration. The new version of ISO 14971:2019 has been submitted to CEN to be approved as a European Norm or standard. When approved by CEN it still must be submitted to Harmonization for approval. Following publication in the Official Journal you must still determine what the conditions of Harmonization might be as published.
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Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
Original Message:
Sent: 03-Jul-2019 12:32
From: Lena Cordie-Bancroft
Subject: ISO 13485-2016 VS EN ISO 13485-2016
The 'EN' means that the standard is harmonized in the EU to a European directive or regulation. All EN standards need to be implemented by the EU 28 unaltered, meaning no country deviations are permitted, but not all standards are harmonized. At the moment, NO standards are harmonized to the EU MDR and EU IVDR as astandardization request need to be made by the EU commission to CEN to develop a harmonized standard. This harmonization process is critical as compliance with clauses of a standard confers, within the limits of the scope of the standard, a presumption of conformity with the corresponding Essential Requirements/General Safety and Performance Requirements of that directive or regulation.
In response to your specific question regarding ISO 13485:2016 and EN ISO 13485:2016, if selling medical devices to the EU, you need to comply with the EN version, but outside of the EU the non-EN version is required. There is little to no difference in the content of the two, but NB will look for the EN version.
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Lena Cordie-Bancroft
Victoria MN
United States
Original Message:
Sent: 02-Jul-2019 20:17
From: Anonymous Member
Subject: ISO 13485-2016 VS EN ISO 13485-2016
This message was posted by a user wishing to remain anonymous
Dear RAPS members,
I would like to understand the difference between ISO 13485-2016 and EN ISO 13485-2016 with regard to CE marking a class IIb and class III device in EU.
The conformity assessment route requires full QMS and technical documentation preparation for class II and III. If ISO 13485 does not address all requirements of Article 10(9) so what would be the best approach? Is it true that a Notified Body may ask for compliance with EN ISO 13485-2016 instead of ISO 13485-2016?