During an audit, our notified body indicated that there would be a deviation noted for not keeping the design dossier up to date, specifically with respect to including a technical assessment for conformity to 60601-1-6 and 60601-1-4. The device was developed prior to 60601-1-6, yet there seems to be an expectation that the design dossier needs to be updated to reflect compliance to these standards, even though it is currently CE marked (expires January 2010).
Does anyone have any guidance or information regarding retroactive requirements to be compliant to a voluntary standard or experience with updating design dossiers as new standards become available?

Thank you for your help.

During an audit, our notified body indicated that there would be a deviation noted for not keeping the design dossier up to date, specifically with respect to including a technical assessment for conformity to 60601-1-6 and 60601-1-4. The device was developed prior to 60601-1-6, yet there seems to be an expectation that the design dossier needs to be updated to reflect compliance to these standards, even though it is currently CE marked (expires January 2010).
Does anyone have any guidance or information regarding retroactive requirements to be compliant to a voluntary standard or experience with updating design dossiers as new standards become available?

Thank you for your help.From the MDD Annex 1 Essential Requirements, General requirements2. The solutions adopted by the manufacturer for the design and construction of the devices must conform to
safety principles, taking account of the generally acknowledged state of the art.Also discussed in this thread. (http://elsmar.com/Forums/showthread.php?t=29649)

Our understanding is that a Design Dossier is not a static document that can remain in place unmaintained for a period of time, and still remain valid.

Rather, it requires vigilant maintenance, because if a standard newly becomes applicable to the covered product(s) and the Design Dossier is not updated to either indicate conformance to that newly applicable standard or to provide a rationale for why not, the Design Dossier is nonconformant.

Ditto for CE Declarations of Conformance, and for Technical Files.

We've just been contacted by one of our largest customers in regard to a recent EN standard. Our customer has their own standards vigilance, and they expect us to notify them of our compliance actions...including an updated CE Declaration of Conformance...to close their vendor-supervision loop.

Not that we would go there, but theoretically if we were to tell them to take a hike, our sales to their European unit would stop, and our top-level relationship with them would be damaged. They expect us to be conformant.

That's how it works. Regulatory compliance is a process, not an event.

It's both a snapshot in time (the device and supporting documentation were compliant at the time of submission) and also evidence that the requirement to maintain that compliance, as the clinical, technical and regulatory environments inevitably evolves over time, has been met.

So you need strong revision control.

I would be wary of having an "annual update" or similar. The supporting documentation needs to be updated as required.

Make sure you have a system for post-market feedback. The NB-MEDs (www.team-nb.org/Documents/R2_12-1_rev11.pdf)and MEDDEV documents are valuable sources of guidance, as is GHTF (http://www.ghtf.org/sg2/).

Thank you all for your responses. While I understand that the design dossier needs to be updated to reflect the current device, since as revised labeling, updated post-market information and the risk management/ assessments, the question I still have remains as to whether new tests have to be performed on an existing device that was designed before the standards were available.

For example, if the "voluntary standards" are a means to demonstrate compliance to the essential requirements, and the device currently has the CE mark, which means it does comply with the ER, then why would it no longer comply with the ER if a new standard is released and the essential requirements haven't changed. This question is based on the following quote from the europa web site:
Compliance with harmonised standards, of which the reference numbers have been published in the Official Journal and which have been transposed into national standards, provides presumption of conformity to the corresponding essential requirements of the EC directives. Compliance with harmonised standards remains voluntary, and manufacturers are free to choose any other technical solution that provides compliance with the essential requirements. In a number of cases compliance with harmonised standards also increases the options for conformity assessment procedures.
Since the device is currently approved and on the market, which means that comformity to the ER is established, then why would new tests have to be performed because a new harmonized standard is released? For instance, if the alarms only had one harmonic in the audible alarm, then 60601-1-8 is released and it requires 4 harmonics, then does the existing, approved and marketed device have to be redesigned to comply with the standard, even if no issues were identified since it has been marketed?

I'm sorry for the long-winded questions, but it just seems to me that if the device complies with the ER, the solutions adopted to comply are sufficient, then the device should not have to be redeisgned as new standards are released.
In a releated question, when 60601-1 3rd edition is harmonized, does this mean that every currently marketed medical device will have to be evaluated, redesigned or otherwise assessed to continue to be marketed?


Thanks again for your valuable input and viewpoints.

As always, the answer is...it depends.


Notified Bodies' approach to harmonised standards is pretty much set. If you don't meet them, you need a damn good reason why.

So if a standard gets revised, you need to demonstrate that you not only are aware of the change, but that you have assessed the impact on your product.

If you can do a Gap Analysis that legitimately shows that the changes are either only cosmetic, or that the gap can be closed via literature review, then you might well be able to get away without doing additional laboratory tests.


But the misconception you have is that because something was originally approved as safe and effective, that it will always remain so. After all, asbestos was popular once upon a time. But our knowledge improved over time, and now asbestos is treated with extreme caution.

I have no idea about your warning alarms example. But I imagine the standard changed because there had been problems, albeit maybe not with your product.

Now whether or not you need to redesign your product, quarantine old inventory, and perhaps even recall old issued product....well it depends. At the very least you will need to justify why you are not doing some or all of those things.

Certainly some of us agree with you that it's a hassle to adapt to a regulatory context in which when a new rule is published and adopted, previously conformant products that were long ago "finished" and given over to Marketing and Production all have to be reviewed and maybe redesigned.

In the medical devices area, the FDA historically has mostly not operated according to such a principle. In regard to 510(k)s, for instance, a premarket notification acceptance once granted has (generally) remained valid indefinitely, irrespective of subsequent regulatory changes that are applicable to new comparable devices. The generally used term is "grandfathering", a well-worn concept in regulatory law.

It's particularly aggravating when the newly introduced standard is poorly drafted with a broader scope than its technical language correctly handles. EN 13795, recently published, has that problem. Its scope clearly encompasses all surgical drapes, including non-patient-contact equipment covers. Its technical language, though, assumes patient contact applications, and assumes woven or non-woven fabric materials in regard to the specifically directed test methods...providing no obvious way to establish compliance for disposable-plastic-film devices, which are by far the most common technology worldwide for non-patient-contact equipment covers in the sterile field, and are otherwise quite broadly accepted at the clinical level and regulation-wise in Europe.

One of my current problems is figuring out how to maximize and then state our conformance position to 13795 for the hundreds of products we make to which it applies, given this poor performance by the standard's drafters.

But that's how the EU system works: no grandfathering--both old and new standards are applicable.