Self Certified Class I and Class I Sterile

[tulip222]

Hello,

Is it best to create two Technical files for Class 1 sterile with NB involvement and another for Class 1ns or can they sit under the same file? same product family group other than the sterility aspects

currently they have two DOC's and two separate basic UDI's so I'm thinking maybe best to make two and keep separate

 

[shimonv]

I believe you need to separate Technical Files. The NB is not responsible for non-sterile class I device and from my experience in such cases they would not want to see it Technical File that they review.

Shimon

 

[Philip B]

If sterility is the only difference between the two product types then I would have one file only. Your NB will only look at the sterility aspects and will ignore the rest anyway. Saves a lot of work.

 

[tulip222]

thank you I tried this but our EU rep suggested 2 files as wanted two basic-udi's for Class I and Ins
If it was IIa id obviously leave in one. Id rather that way!