Clinical Evaluation of IVD Medical Devices

Hi All,

I have a few questions regarding the Clinical Evaluation for an IVD medical device. Can anybody help me on the questions below?

1. Is MEDDEV 2.7.1 applicable for European Directive 98/79/EC (IVDD)?

2. Is there any other guidance document that we can refer to for Clinical Evaluation besides the SG5/N2R8:2007?

3. We intend to get CE marking for our IVD medical device.
a) In this case, can we adopt the CLSI standards in our validation protocols even though we are not going to sell our device to US market?

b) Is there any other harmonized standards or guidance document that we can refer to for our verification & validation protocols?

Much appreciated if someone could help me on this.

Bumped

1. Is MEDDEV 2.7.1 applicable for European Directive 98/79/EC (IVDD)?

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No, it only applies to the MDD and AIMDD directives.

2. Is there any other guidance document that we can refer to for Clinical Evaluation besides the SG5/N2R8:2007?

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There's at least 3 documents on performance evaluation on IVDs created by GHTF - http://www.imdrf.org/documents/doc-ghtf-sg5.asp

There also EN 13612:2002 - Performance evaluation of in vitro diagnostic medical devices

3. We intend to get CE marking for our IVD medical device.
a) In this case, can we adopt the CLSI standards in our validation protocols even though we are not going to sell our device to US market?

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For the directives, you can apply anything you want. However, to gain presumption of conformity, if need to apply harmonized standards (in this case, the mentioned EN 13612:2002. If you don't, things may still be acceptable, but you won't get presumption of conformity).

b) Is there any other harmonized standards or guidance document that we can refer to for our verification & validation protocols?

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Depending on the device, there may be specific documents.

esh14 said:

Hi All,
1. Is MEDDEV 2.7.1 applicable for European Directive 98/79/EC (IVDD)?

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No, it specifically excludes IVD's.

esh14 said:

Hi All,
2. Is there any other guidance document that we can refer to for Clinical Evaluation besides the SG5/N2R8:2007?

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FDA normally doesn't require clinical trials, but they have various guidance documents on their website in case you need them. Besides they accept the GHTF (IMDRF) guides.

IVD's are not my area of specialism, however I will give it a go:

1. I would say that the meddev is not directly applicable, from a search of the directive "clinical evaluation" does not appear in the text, only performance validation; I'm not entirely clear on the use of a clinical evaluation of an IVD product.

2. sorry, I don't know

3. In the EU you can use any standard - be it internationally recognised or an internal standard. You just have to demonstrate how that standard supports you in meeting the Essential requirements

4. Harmonised standards for the IVD directive can be found here: http://ec.europa.eu/growth/single-m...ds/iv-diagnostic-medical-devices/index_en.htm

Having a quick look at the list (and without knowing exactly what you are looking for) you may be interested in EN 13612, EN ISO 20776-1, EN ISO 23640

Be sure to classify your device correctly according to the IVD directive. You might be exceeding the actual requirements.

Ronen E said:

Be sure to classify your device correctly according to the IVD directive. You might be exceeding the actual requirements.

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We understand that the CLSI consensus standards are more detailed and more stringent compared to EU harmonized standards.

We referred to the CLSI consensus standards in our protocols as initially US is the first target market for our product. However, we have changed our plan and decided to get CE marking for our product first before we release our products to other countries.

Thus, I'd like to know if we should prepare two separate sets of clinical performance study protocols and records for EU & US FDA submission. May I know whats the usual industry practice in the market?

Your advise is greatly appreciated.

FDA normally doesn't require clinical trials,

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Please note that clinical evaluation is not clinical trial. Clinical trials may be used as part of clinical evaluation (I do think that the requirements for clinical evaluation / performance evaluation in the directives are the best ones related to clinical data).

1. I would say that the meddev is not directly applicable, from a search of the directive "clinical evaluation" does not appear in the text, only performance validation; I'm not entirely clear on the use of a clinical evaluation of an IVD product.

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"Performance evaluation" is more or less "clinical evaluation" for IVDs (because it does not rely on clinical data, but on performance data). You can check the difference in some GHTF documents at http://www.imdrf.org/documents/doc-ghtf-sg5.asp

You might be exceeding the actual requirements.

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I usually prefer to focus on doing the right thing instead of only basing on the "actual"requirements (which are generally only a part of the you should do, because, as requirements, they usually are written in a way that they focus the expectations in only a few words).. This is in my opinion of of the worst problems we have right now in RA, because a lot of manufacturers who does not know the basics of what they do (I'm not saying this is the case here) simply try to do do as low as possible to only meet the requirements. Then, when the expectations and thus the requirements changes, they are at a loss.

Anyway, you are right in mentioning this, because if the device is not on the lists of Annex II, performance evaluation is not expected.

Marcelo Antunes said:

Anyway, you are right in mentioning this, because if the device is not on the lists of Annex II, performance evaluation is not expected.

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This is what I was referring to.

Similarly, no point applying class III requirements to a class I medical device. That's the whole point of classification.

Ronen E said:

This is what I was referring to.

Similarly, no point applying class III requirements to a class I medical device. That's the whole point of classification.

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A noob question, sorry, why is performance evaluation not expected if the device is not on the lists of Annex II