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27 January 2011


Ron Jeffrey

Hello - My question. If all clinical work is done in the USA and my class 2 device is CE marked and sold in the EU, must I have meet 14155 (current) to claim compliance to 6a?
Thank you

Nancy J Stark

Hi Ron,
Clinical trials are only subject to the rules of the country in which they are done. A completed clinical trial won't have to be "improved".

But a trial that is in progress in Europe will need to be brought into compliance with ISO 14155 as soon as it is cited in the Official Journal.

Frank Schmidt

Dear Nancy and team, we heard recently that under the new 14155, the point of enrollment will be the patient's signature of the informed consent form. Is this correct? Do you know if this was one of the key-conditions for the FDA delegates to accept the standard?
Thank you very much

Nancy J Stark

Hi Frank,
Yes, it is true, the point of enrollment occurs at the same time as the patient signs the informed consent. And yes, it was a requirement of FDA in spite of many persuasive arguments to the contrary.

My take on it is that FDA is concerned that subjects will sign a consent form, be found ineligible for the study, and this in-eligibility won't be reported. FDA kept saying things like "we don't want them to be lost" or "we want to know what happens to everyone."

I really think it was more of a semantic issue than a real one. Just keep a log of everyone who sign the consent form and is thereby enrolled, then keep another log of subjects who are exited from the study because they aren't eligible, and think of a new word for "enrolled", such as subjects who "joined" the study.

Patrick Bohan

Dear Nancy,
Thanks for the opportunity to direct questions to you. Any guidance on what note 3 (3.2, AE definition, page 2) means? "For users or other persons, this definition [of AE] is restricted to events related to investigational medical devices."

Nancy Stark

Hi Patrick,
The idea was that if an investigational device injured a caregiver it should be reported. But we didn't want this requirement to carry over outside of the scope of investigational devices, lest we step on TC 210 post market surveillance toes.


Patrick Bohan

Thanks Nancy. Understood. Along the same lines: in pharma trials, it is typical to collect only SAEs (i.e. no more AEs) 30 days after the last dose of the investigational drug. In the case of an implantable device, however, when is it reasonable to stop collecting AE data and only collect ADEs, SAEs, incidents and deficiencies? 6.4.1 of ISO 14155:2011 seems to suggest that we must always collect them (that means collecting, say, colds and flu data even 12 months after an implant) whereas A.14.d appears to suggest that it is up to the sponsor in the CIP to define such timelines. If the CIP defined all AEs until 30 days after implant and then only SAEs, ADEs and incidents/deficiencies for the rest of the study, would that work?

Nancy J  Stark

Hi Patrick,
You raise an interesting question about how much is enough. We left the standard a little vague on this because we felt the CIP (with approval) should rule the study to provide flexibility.

I think your plan sounds like a good one.


hana gadassi

we are engaged in developing combinatin product-Drug delivery system.The first step is creating micro channels in the skin using a elctro programable device.After this initial step we apply drug patch on the skin.All clinical studies are condcted under ICH 6. What we are missing if we do not follow 14155? Do we need to follow /do some thing differently?We collect sae only about 1-2 weeks folllowing stop of the study unless their is an event that needs follow up.

Michael Yessik


The description is of 14155:2011, but the snapshot from the Europa site shows 14155-1:2009 and 14255-2:2009. Are these identical?

mary spadola

Where can one get access to a printable version of the updated ISO 14155-2011

Nancy Stark

Good question Mary. You can buy it online from either www.iso.org or www.aami.org or from the standards body of any other country. You will have to pay about $80.


Henry Chung

Dear Nancy:

Does ISO 14155 applies to countries like Singapore, China or only to EU?


Hello Henry,

It is my understanding that With the exception of India, most of the member states of AHWP have stated they will implement ISO 14155:2011 for the conduct of medical device clinical investigations in their country. This includes countries such as China, Singapore, Indonesia and many more. It does not include Japan.


Does anyone know when the standard might be listed in the Official Journal?


Hi Lisa,
My European friends say "any day now", but it has not been adopted as of 30March2012.
You can check at this website: http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm Search for "14155" and see if the 2011 version is listed. Nancy


Dear Nancy,
I was wondering if the ISO guidelines require ALL adverse events and device deficiencies to be reported to the sponsor regardless of the type of study. The guidelines are little vague on this aspect.
For example, if the study is a post-marketing observational study, can the AE/DD reporting be limited to serious and unexpected only?


Hello Louise,
Good question. We have to look to who has the power. The standard, all by itself, has no power or authority whatsoever. When the EU harmonized the standard they did so with regard to getting Notified Body approval for commercialization--that would mean post-market studies are outside the scope of the standard.
The committee who wrote the standard wanted to encourage everyone to use the standard in all human research situations. Hence the vagueness. But look to the law, only human investigations prior to commercialization are covered.

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