Preparing the Technical File for a 12 Lead ECG Monitor

[Regulatory]

Hi,

We are preparing the Technical File for the 12 Lead ECG Monitor.

Should we have to submit the Clinical Report, If yes can any guide us how, if No...how to submit?

In FDA if we follow the Guidance for Industry - Diagnostic ECG Guidance (EC 11) standard - its is enough, there is no need to submit the Clinical Reports.

Will the same can be followed for CE Marking procedures also....I tried to look at the MDD Directives but i couldn't find any information!

Can any one please help us!

[Al Rosen]

Originally Posted by Regulatory

Hi,

We are preparing the Technical File for the 12 Lead ECG Monitor.

Should we have to submit the Clinical Report, If yes can any guide us how, if No...how to submit?

In FDA if we follow the Guidance for Industry - Diagnostic ECG Guidance (EC 11) standard - its is enough, there is no need to submit the Clinical Reports.

Will the same can be followed for CE Marking procedures also....I tried to look at the MDD Directives but i couldn't find any information!

Can any one please help us!

You need to include this as part of your Technical File which your Notified Body will review.

[Regulatory]

Can you please be more specific.......!

[Al Rosen]

Originally Posted by Regulatory

Can you please be more specific.......!

First you need to read and understand the MDD. You will then need a Notified Body to which you will submit your Technical File for review. Your ISO 13485 Registrar may be able to help you.

[Regulatory]

First you need to read and understand the MDD. You will then need a Notified Body to which you will submit your Technical File for review. Your ISO 13485 Registrar may be able to help you.

Hi...Thanks for your inputs.

We are certified as ISO 13485:2003 company...we have also got the CE Marking certification for our new product.

I went through the complete MDD - 93/42/EEC Directive....It is general document.

My Question is....Since ECG is proved concept should we need to submit the Technical File with the Clinical documents!

I hope my question is clear!

[chris1price]

Hi
Read through Annex X, section 1.1, this explains what you need to meet Section 1 and 3 of the ER. You either need clinical data or a suitable compliation of scientific literature. You can use information on predicate devices as part of the literature review.

What type of clinical data is required is a discussion you need to have with your Notified Body. Depending on the product classification and the history with the client, sometimes Notified Bodies will want this submitted in advance and other times it will only be examined during an audit.

[Al Rosen]

Originally Posted by Regulatory

First you need to read and understand the MDD. You will then need a Notified Body to which you will submit your Technical File for review. Your ISO 13485 Registrar may be able to help you.

Hi...Thanks for your inputs.

We are certified as ISO 13485:2003 company...we have also got the CE Marking certification for our new product.

I went through the complete MDD - 93/42/EEC Directive....It is general document.

My Question is....Since ECG is proved concept should we need to submit the Technical File with the Clinical documents!

I hope my question is clear!

Yes, you do. You also need to comply with IEC 60601-1 and any other appropriate harmonised standard. Again, this is something your Notified Body will tell you. I hope that I have been clear enough. You need a Notified Body!

[Regulatory]

Thanks for your inputs!

It's been great learning experience.....we have Notified body but the problem is they are very slow in response.