Differences between Technical File part a and part b

[dinda]

Dear All,

In the council directive 93/42/EEC, we are all familiar with technical file. in NB-Med 2.5.1 there are two part.

Can anyone tell me what kind both of diference actually is, may be give me sample

In our case, our products are condoms (2b)

Thanks for your help.

Dinda

[jkuil]

Please see this helpfull presentation by the BSI