The definition of a surgically invasive device in EC directive 93/42/EEC is:

'Surgically invasive device

An invasive device which penetrates inside the body through the surface of
the body, with the aid or in the context of a surgical operation.

For the purposes of this Directive devices other than those referred to in the
previous subparagraph and which produce penetration other than through
an established body orifice, shall be treated as surgically invasive devices.'

Is it the intention of the second paragraph (For the purposes of the directive...) to classify (for example) hypodermic needles, lancets and so on, which penetrate the body other than through an established body orifice but not necessarily in the context of a surgical operation, as surgically invasive devices? Or am I missing something here?

Thanks

Mike Caudwell

The definition of a surgically invasive device in EC directive 93/42/EEC is:

'Surgically invasive device

An invasive device which penetrates inside the body through the surface of
the body, with the aid or in the context of a surgical operation.

For the purposes of this Directive devices other than those referred to in the
previous subparagraph and which produce penetration other than through
an established body orifice, shall be treated as surgically invasive devices.'

Is it the intention of the second paragraph (For the purposes of the directive...) to classify (for example) hypodermic needles, lancets and so on, which penetrate the body other than through an established body orifice but not necessarily in the context of a surgical operation, as surgically invasive devices? Or am I missing something here?

Thanks

Mike CaudwellThat appears to be true. Look at MED DEV 2.4/1, Guidelines on Medical Device Classification and the GHTF proposed guidance on Medical Device Classification. Both of these are helpful.