Chris,
Where the Designer/manufacturer is outside the EU it is the
person who imports the product into the region who will be held
accountable for any CE compliance non-conformities. Obviously it
is in their interest to ensure they are supplied with CE marked
compliant products.
The CE mark is required on products to cross European Borders,
you can integrate non-CE marked components into systems and
products where the system can be CE marked upon satisfying the
relevant EU Directives. Conversely using only CE marked products
in a system does not necessarily mean that any particular
directive is complied with (known as; CE+CE is not equal to CE -
looks better with the correct symbol).
I've put answers to your other questions below:
Cheers,
Colin.
My questions are:
4. If we are only supplying part of the total system (the software
and pager) yet the system design and specifications are ours, are we
still considered the "manufacturer" under the medical device directive?
:Yes
5. If the distributor places their name on the product, (and
assumes all responsibilities except design) do they become the
"manufacturer"?
:They can be responsible and subcontract the design as they might the
manufacture or even the compliance testing.
