NIST GCR 01-815
A Guide to the EU Medical Device Directive

XII. Declaration of Conformity (See NIST SP 951 A Guide to EU Standards and Conformity Assessment, Page 26.)

The manufacturer must draw up a Declaration of Conformity and keep a copy with the technical file. The Declaration of Conformity must contain the following:

• Name and address of the manufacturer and/or his Authorized Representative;
• Product name of the device;
• Reference to the applicable Directive
• Reference to applied Harmonized Standards;
• Where appropriate, references to the specifications with which conformity is declared; and
• Identification of the signatory who has been empowered to enter into commitments on behalf of the manufacturer or his Authorized Representative established within the Community.

For a sample Declaration of Conformity, see NIST SP 951 A Guide to EU Standards and Conformity Assessment, Page 28.

FOR FURTHER INFORMATION, PLEASE REFER TO THE FOLLOWING TEXT OF THE DIRECTIVE.

Return to the Table of Contents

Previous Page

Next Page