CE Mark & Harmonized Standards

[amjadrana]

I have come upon another similar regulatory issue for which I seek guidance from the forum.

We are a manufacturer of a hearing diagnostic and screeing product. We are testing our product according to safety standard IEC 60601-1 and relevant EMC standards. A particular standard IEC 60601-2-40 is also applicable to us. According to the standard IEC 60601-1, a particular standard takes precendence over the relevant clauses of the general standard.

Question: Does it mean that compliance to IEC 60601-2-40 is also mandatory in addition to IEC 60601-1?

I have another question. If we have submitted our product for regulatory testing, can we market our product, when we receive test report from the testing authority that our product has passed the requirements of the standard or do we have to wait until the actual certificate is in our hands.

Thanks for your inputs

[Al Rosen]

Originally Posted by amjadrana

We are a manufacturer of a hearing diagnostic and screeing product. We are testing our product according to safety standard IEC 60601-1 and relevant EMC standards. A particular standard IEC 60601-2-40 is also applicable to us. According to the standard IEC 60601-1, a particular standard takes precendence over the relevant clauses of the general standard.

Question: Does it mean that compliance to IEC 60601-2-40 is also mandatory in addition to IEC 60601-1?

Yes it does.

Originally Posted by amjadrana

I have another question. If we have submitted our product for regulatory testing, can we market our product, when we receive test report from the testing authority that our product has passed the requirements of the standard or do we have to wait until the actual certificate is in our hands.

It is not clear as to where you are marketing this product.

[amjadrana]

Thank you, Al, for the quick reply. We are intending to market the product first in the USA and then to Asian markets and finally internationally.

What is acceptable for FDA? A certificate or conformance to the standard as a report. It is important to know the difference, because it may take some time for the testing lab to send actual certificate. They can send us the report quickly.

Thank you again in advance.

[Al Rosen]

Originally Posted by amjadrana

Thank you, Al, for the quick reply. We are intending to market the product first in the USA and then to Asian markets and finally internationally.

What is acceptable for FDA? A certificate or conformance to the standard as a report. It is important to know the difference, because it may take some time for the testing lab to send actual certificate. They can send us the report quickly.

Thank you again in advance.

It depends on the device classification. You may not export to the US without meeting the FDA requirements, which go way beyond testing the device to the standards you referenced. The first step is determining the classification of your device to determine what controls are required. Look at FDA's website Importing into the US, where you can find links to the information you will need.

[amjadrana]

Our device is a class II product. We have got 510k approval. In our certificate of conformance, we stated that we shall conform to safety standards including IEC 60601-1. Would conformance mean availability of test report indicating our product meets the requirements of the standard or is it necessary to have the certificate in hand to start marketing the product in USA?

[Al Rosen]

Originally Posted by amjadrana

Our device is a class II product. We have got 510k approval. In our certificate of conformance, we stated that we shall conform to safety standards including IEC 60601-1. Would conformance mean availability of test report indicating our product meets the requirements of the standard or is it necessary to have the certificate in hand to start marketing the product in USA?

Do you mean as part of the 510k, you made a statement that you would conform to the standards? If so, IMO, the report is all you need?

[amjadrana]

Thank you. That is my understanding as well. The certificate is based on the test report. But is there any regulation saying that actual certificates and not the test reports are required to substantiate the compliance?

This may seem basic, but a few days between getting the report and obtaining the certificate may make a difference in shipping the first product out and still meeting the regulatory aspects.

I hope I made myself clear.

[Al Rosen]

Originally Posted by amjadrana

Thank you. That is my understanding as well. The certificate is based on the test report. But is there any regulation saying that actual certificates and not the test reports are required to substantiate the compliance?

Not that I'm aware of.