Choosing a notified body for a new start up company in the UK - Medical Device area

[Denis]

Hi
I'm looking for some information in choosing a notified body for a new start up company in the Medical Device area.

Will need ISO9001:2000, ISO 13485:2003, we will be manufacturing Class I medical devices with a self certification of the CE mark.

Got a short list of 3 .

SGS, Bsi,LRQA.

need some contact information and approx costings.

Small company with approx 6 people on start up.

 

[Al Rosen]

Hi
I'm looking for some information in choosing a notified body for a new start up company in the Medical Device area.

Will need ISO9001:2000, ISO 13485:2003, we will be manufacturing Class I medical devices with a self certification of the CE mark.

Got a short list of 3 .

SGS, Bsi,LRQA.

need some contact information and approx costings.

Small company with approx 6 people on start up.

Denis, I was under the impression that Class I devices did not require a NB.

 

[Denis]

We want to have accrediatation to 9001 & 13485 as a company business management tool. So we're off to a good start already.

We'll need to have a technical file and the essential requirements checklist completed. I know that the Class I non sterile device does not need formal approval, but again we'd like to have our notified body rubber stamp our CE mark - almost as a form of voluntary independant approval.

 

[Al Rosen]

We want to have accrediatation to 9001 & 13485 as a company business management tool. So we're off to a good start already.

We'll need to have a technical file and the essential requirements checklist completed. I know that the Class I non sterile device does not need formal approval, but again we'd like to have our notified body rubber stamp our CE mark - almost as a form of voluntary independant approval.

Since it is not required, would the NB's certificate number still appear with the CE mark?

 

[Denis]

No notified body number on the CE mark.
Technical file compiled for history and record keeping purposes only.

 

[Microbe]

Hi Denis,

If you look at www.medical-devices.gov.uk, under key topics you will find a document called UK Notified Bodies - this will give you a list and contact details.

It may be that NB's are not interested in class 1 non-sterile, but you can but ask. I think you still need a technical file and will need to register with the MHRA - details again on the web site

Good Luck

Microbe

 

[Denis]

Thanks Microbe

Just what I was looking for.
I agree with you (notified body won't really be interested in ClassI non sterile), but the file will exist and we will contact MHRA.

Thanks.