everything in place
and correctly done. Do not try to cut corners.
My company registers products and acts as an authorised representative and
we get audited for completeness of documentation. Do not forget that you
need a vigilance scheme in place - the competent authorities always check
this one
) and
(6) and any other natural or legal person engaged in the activities referred
to in Article 12 shall inform the competent authorities of the Member State
in which he has his registered place of business of the address of the
registered place of business and the description of the devices concerned
Dear Members,
In the EEC if I register a Class I Medical Device with a Competent Authority
in one Membered State, must I register with other Competent Authorities as
we eventually market product their State. All input is appreciated.
Regards,
Mark Schmidt
X-Rite Incorporated
Grandville, MI
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