Hi,

For the Medical Directives and I am assuming, for the others, the
"manufacturer" is the company who's name is on the product.  In your
example, Company B is responsible for the technical file and DoC.  If they
are basing their DoC on a technical file held by Company A, they should have
contractual access to that information.

Ned


Ned Devine
Program Manager III
Entela, Inc.
3033 Madison Ave. SE
Grand Rapids, MI  49548

Phone 616 248 9671
Fax  616 574 9752
e-mail  [email protected]

-----Original Message-----
From: [email protected] [mailto:[email protected]]
Sent: Tuesday, February 27, 2001 10:08 AM
To: [email protected]
Subject: DoC



Companies A and B are located in the EU. Company A manufacturers a product
and applies the name of Company B. Company B sells the product to a customer
and the product is shipped from Company A direct to the customer.
Which company is responsible for the technical file and issuing the DoC?

Richard Woods

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