CE MDD 93/42/EEC Class I Technical File Help

eaglecokr · May 25, 2010

Hi All,

I wonder if anyone has MDD 93/42/EEC Calss I Technical File Samples or Templates or even Fully Completed (Written) TF that they can share as a guideline for our CE TF.

I am new to this and just dont know how to approach.

Templates or Samples would definitely a great life saver!

The product is a medical software.

Thanks

:crybaby:

harry · May 25, 2010

There's a guidance document in this post. Not sure how much it will help!

chris1price · May 25, 2010

Hi

I would suggest looking at the MHRA guidance on Class 1 devices:
https://www.mhra.gov.uk/home/groups/es-era/documents/publication/con007511.pdf

However this predates the recent ammendments. You will need to add a Clinical Evaluation to the file.

Chris

bio_subbu · Aug 23, 2010

In addition to above, I would suggest you to refer MDEG’s (Medical Devices Expert Group) Guidance Notes for Manufacturers of Class I Medical Devices.

A copy of guidance document can be obtained from here.

Regards
S. Subramaniam

jaygrey · Aug 30, 2013

helpful.thanks

CE MDD 93/42/EEC Class I Technical File Help

eaglecokr

harry

chris1price

Attachments

bio_subbu

Attachments

jaygrey

Similar threads