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Hello all, Maybe this is a basic question for many of you, but I have a doubt regarding the Standards that should be declared on the Declaration of Conformity according with the MDD 93/42/EEC. The Situation is, the harmonized standard EN 60601-1:2006/A1:2013 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance will be mandatory since 31/12/2017. During the recertification Audit, we had some findings relating to this: The test reports are based on the EN 60601-1:2006/A1:2013, and the collateral standars that are aligned with it were tested (with amendments). For example 60601-1-8:2006/A1:2012, this standard is not harmonized with the amendment and the modifications introduced by A1 imply that the product no longer comply the previous version (harmonized). The collateral standard with the amendment superseded the harmonized standard. So the question is, can I list the 60601-1-8:2006/A1:2012 on the Declaration of conformity? or only the harmonized standards should be listed? I hope the explanation is clear, please let me know and I will try to describe again. Thanks a million!! PD: My thought is that the harmonized standards are voluntary and the manufacturer can choose other standards if he can demonstrate presumption of conformity with the Essential Requirements. So, if the product complies with an improved version of the standard should be good to declare it on the DoC. The thing is that in one of the findings the auditors stated that we declared an ISO standard that is not harmonized – this made me doubt. source: https://www.linkedin.com/groups/78665/78665-6164868428059406339 Marked as spam
 Posted by Asked on July 29, 2016 12:00 am
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Julie Omohundro
Ana, you might also want to post this question at Elsmar Cove:
http://www.elsmar.com/Forums/index.php It has a forum dedicated to medical device standards and a subforum dedicated to ISO 60601. And some very knowledgeable and helpful people there. Marked as spam
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Marcus Gould
The medical device/IVD CE mark is one of a number of CE marks which come under the New Approach within Europe. The guidance document for the New Approach regulatory framework is the European Commission ‘Blue Guide’ which can be found at: http://ec.europa.eu/DocsRoom/documents/18027. It is a very long and detailed read but sets the medical device framework into context.
The requirement for what goes into the Declaration of Conformity is detailed on page 57, section 4.4, and indicates standard EN ISO/IEC 17050-1 Conformity assessment — Supplier's declaration of conformity - Part 1: General requirements’ should be followed. This standard details what technical standards should be listed on the Declaration of Conformity. I have written on this subject before – please see my article at: https://www.linkedin.com/pulse/declaration-conformity-what-good-marcus-gould?trk=mp-author-card Marked as spam
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Romuald Urbański
In the future we find this requirements in MDR (Medical Device Regulation) ANNEX III "EU DECLARATION OF CONFORMITY"
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Robert Poyser
I would take a look at the CE mark Essential requirements document, this should have the harmonised standards you product is designed, manufactured and tested against.
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Maurizio Colombo
Not an expert in that particular standard, but just some general considerations, hoping those will be useful.
Harmonized standards are voluntary, but they are also the only ones that give presumption of conformity to the Essential Requirements, as stated in the Directive and with the limitations indicated in the Annexes "Z". If you use a non-harmonized standard, you shall give the NB a valid rationale demonstrating that through this standard you are actually granting a level of safety and performance which is equal or greater than the one achieved with the "old" version of the standard. Marked as spam
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