IVD - Self Declaration - Technical File - Template wanted

Thukira

Involved In Discussions
#1
Hi.. I'm completely new IVD, can someone help me out with Technical File Template for IVD - self declaration please
 
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chris1price

Trusted Information Resource
#2
For the existing IVD directive, there is no specific Technical File. I would suggest looking at the GHTF STED (Summary of Technical Documentation) guidance (GHTF/SG1/N063:2011).

Alternatively, a better solution would be to start working towards the new IVD Regulation. There will be very few self-certified IVDs under the regulation, most will require a NB.
 

Thukira

Involved In Discussions
#5
Hi Chris, thanks for sharing the link

I have just checked, Class I applies to our product as it is laboratory equipment which will not be in contact with patient.

Should i refer GHTF STED (Summary of Technical Documentation) guidance (GHTF/SG1/N063:2011) ?

Pl suggest
 

chris1price

Trusted Information Resource
#6
Hi, the link I pointed to, contains both the Medical Device and IVD Regulations. Sorry, there are many links and this wasn't the best one. IVDs are Class A, B , C and D, there is no class I.

You need to look at Annex VIII on pages 307 & 307. An automated testing machine is typically class D, but the test itself is likely to be Class C or higher.

If you are new to this, there is a lot of guidance on the regulation available on-line. A google search will give you lots of information, or talk directly to a notified body or consultant.

Chris
 

Thukira

Involved In Discussions
#7
Hi chris

I feel "Class A" will apply as per definition as the device is laboratory equipment intended for in-vitro diagnosis where there wont be any patient contact with equipment, only the sample will be taken from patient for analysis using this device.

Rule 5 The following devices are classified as class A:

a) products for general laboratory use, accessories which possess no critical characteristics, buffer solutions, washing solutions, and general culture media and histological stains, intended by the manufacturer to make them suitable for [FONT=EUAlbertina,EU Albertina][FONT=EUAlbertina,EU Albertina]in vitro [/FONT][/FONT]diagnostic procedures relating to a specific examination;

(b) instruments intended by the manufacturer specifically to be used for [FONT=EUAlbertina,EU Albertina][FONT=EUAlbertina,EU Albertina]in vitro [/FONT][/FONT]diagnostic procedures;

(c) specimen receptacles.

 

Thukira

Involved In Discussions
#8
Hi chris

I feel "Class A" will apply as per definition as the device is laboratory equipment intended for in-vitro diagnosis where there wont be any patient contact with equipment, only the sample will be taken from patient for analysis using this device.

Rule 5 The following devices are classified as class A:

a) products for general laboratory use, accessories which possess no critical characteristics, buffer solutions, washing solutions, and general culture media and histological stains, intended by the manufacturer to make them suitable for [FONT=EUAlbertina,EU Albertina][FONT=EUAlbertina,EU Albertina]in vitro [/FONT][/FONT]diagnostic procedures relating to a specific examination;

(b) instruments intended by the manufacturer specifically to be used for [FONT=EUAlbertina,EU Albertina][FONT=EUAlbertina,EU Albertina]in vitro [/FONT][/FONT]diagnostic procedures;

(c) specimen receptacles.

Can someone help me on this
 
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