Technical File Review for CE Marking.

texkb · Mar 19, 2012

The company I work for, we sell a medical device, is working on getting CE marking. As many of you know part of the CE marking is having your technical file reviewed by an identified agency for approval. We selected an agency as they offered a 30 day review of the technical file. In contacting them last week we discovered that this 30 days was not true and they are now telling us the review period is more like 90 days from when they received the file. They have also indicated that it could be an additional 90 days after the first review if we need to make any changes. This is unacceptable for us especially considering the advertised 30 days. I was wondering if anyone on the forum new of an identified agency for technical file reviews that could provide a very quick review, 30 days or less, on our technical file? Any help anyone could provide would be greatly appreciated.

SteveK · Mar 19, 2012

Re: Techincal File Review for CE Marking.

texkb said:
The company I work for, we sell a medical device, is working on getting CE marking. As many of you know part of the CE marking is having your technical file reviewed by an identified agency for approval. We selected an agency as they offered a 30 day review of the technical file. In contacting them last week we discovered that this 30 days was not true and they are now telling us the review period is more like 90 days from when they received the file. They have also indicated that it could be an additional 90 days after the first review if we need to make any changes. This is unacceptable for us especially considering the advertised 30 days. I was wondering if anyone on the forum new of an identified agency for technical file reviews that could provide a very quick review, 30 days or less, on our technical file? Any help anyone could provide would be greatly appreciated.

Intertek in the UK indicate 30 working days. A new TF I submitted for review a few years ago was turned around within 30 days - including a few minor changes. They currently have another new TF of ours being reviewed. The 30days is up tomorrow, so I will have to see this time!

Steve

texkb · Mar 19, 2012

Re: Techincal File Review for CE Marking.

Steve thanks for the reply. I was not originally sure if I should reference the reviewing agencies name thus I did not include them in the first post. But Intertek is the agency we are currently working with in the US. We had selected them originally for the same reasons you pointed out they had advertised the 30 day review period but not are telling us a very different story. Thus the reason we are looking for a new company.

SteveK · Mar 19, 2012

Re: Techincal File Review for CE Marking.

It could be down to where in the world they are based, the 'experts' they have available etc. Cannot remember where I found the 30 'working' days bit, if it is calender they still have a week or so's grace in my case! I have always had a good working relationship with them, so sorry to hear about your problems with them.

Steve

SteveK · Mar 19, 2012

Re: Techincal File Review for CE Marking.

Additional - very strange, cannot find a current Intertek reference to a 30 day turnround (calender or working days). I wonder if this anything to do with IEC 60601-1 3rd Ed. (panic) TF issues? So other than being told 30 days verbally I will have to wait and see.

Steve

Technical File Review for CE Marking.

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