Dear Forum,

I´m currently planning the Clinical Trials for one of our products.

As part of the process I need to inform Competent Authority about the trials, and part of the information submitted to the CA is a statement that ISO 14155 will be followed.

Now, if ISO 14155 is a harmonized standard like any other harmonized standard, why is compliance to this standard mandatory? (or maybe it´s just the preferences of the CA?)

Does this standard have any special status (officially or unofficially)??

regards
temu

This sounds like a question for the competent authority, such as the agency reviewing trials and application for medical device approval.

This document (www.shdir.no/vp/multimedia/archive/00014/Guidelines_on_Notifi_14826a.doc) mentions that the authoring agency wants compliance to the standard. See Section 4, pages 7-8.

My guess is that the reasoning is the same as when organizations are asked to register to any given standard. There is a desire for some assurance that certain industry-standard needs are being met, without requiring the agency to do its own visits.

Its status would depend on the weight that the agency places on it. If the agency says "You must comply with the standard" for application approval, then the status sounds significant. If, however, the word should is used, then maybe the status is more like that of guidance sufficient to design and conduct trials in a scientifically sound manner and better ensure the device's safety via adequate testing.

Since EN ISO 14155 is published in the List of Harmonized Standards (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2006:277:0002:01:EN:HTML), it is mandatory for manufacturers of medical devices.

For more information on clinical data you could refer to the MedDev Guide for manufacturers and notified bodies (http://ec.europa.eu/enterprise/medical_devices/meddev/2_7.pdf).

HTH ~ghw

Since EN ISO 14155 is published in the List of Harmonized Standards (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2006:277:0002:01:EN:HTML), it is mandatory for manufacturers of medical devices.


But the Harmonized Standards are not mandatory!!!


t.

But the Harmonized Standards are not mandatory!!!


t.

Even though I tend to agree with you, conformance to the harmonized standards is the shortcut to having your clinical trial approved by your NB. It is implemented across the EU, and it forms the minimumrequirements for the member countries to accept the documentation for your trial. It may not be mandatory, but it is required.... :rolleyes:

But the Harmonized Standards are not mandatory!!!


O.K. let's start from the beginning:

There is no law, which can enforce anybody to apply any harmonized standards.

But during the assessment of conformity of your products "it helps" to follow/apply harmonized standards. Because if you declare the application of a harmonized standard, the notified body is allowed to apply the "assumption of equivalent safety".

If you choose to make your own procedure, the notified body has to evaluate, if your method is equivalent to the harmonized standard. Usually this takes time, and time is money.

And now for the Clinical Evaluation:

As a manufacturer of a medical device, you have to fulfill the requirements of Annex X of the MDD 93/42/EEC:

1. General provisions
1.1. As a general rule, confirmation of conformity with the requirements
concerning the characteristics and performances referred to in Sections 1
and 3 of Annex I under the normal conditions of use of the device and
the evaluation of the undesirable side-effects must be based on clinical
data in particular in the case of implantable devices and devices in Class
III. Taking account of any relevant harmonized standards, where appropriate,
the adequacy of the clinical data must be based on:
1.1.1. either a compilation of the relevant scientific literature currently available
on the intended purpose of the device and the techniques employed as
well as, if appropriate, a written report containing a critical evaluation
of this compilation;
1.1.2. or the results of all the clinical investigations made, including those
carried out in conformity with Section 2.
1.2. All the data must remain confidential, in accordance with the provisions
of Article 20.

If you want to save the money for the standard, you should at least follow MEDDEV. 2.7.1 (attached). There can also be some requirements and procedures defined by the competent authority for clinical trials. Such requirements are usually specified in the national medical device law (and by-laws).

But: If you can show, that your product is clinical, technical and biological equivalent to a product, which is already on the market and you provide relevant literature (see clause 4.3. Literature route of MEDDEV 2.7.1) you do not need to perform a clinical trial, you can provide a compilation of the relevant scientific literature (as specified in Annex A of EN ISO 14155-1, that is almost the same text as in MEDDEV 2.7.1)