Document requirements for notifications and export declarations
What information must be included on a Declaration of Conformity (DoC)?
• name and address of the manufacturer;
• the legislation with which the product complies;
• the date of issue and a signature of a competent person;
• the identification of the product;
• name and address of the authorised representative, if applicable;
• the production sites, if applicable.
What information must be included on a CE certificate?
• name and address of the manufacturer;
• the legislation with which the product complies;
• the date of issue and a signature of a competent person;
• the identification of the product;
• the production sites, if applicable.
CE certificates must be issued by a notified body
Documents to be submitted with an IVDD notification
Change requests
o Declaration of Conformity (DOC);
o if applicable, a CE certificate from a notified body for IVDR conformity.
● New IVDD notifications
Key documents:
o product information;
o Declaration of Conformity (DOC);
o valid CE certificate for IVD List A, List B and self-test.
Documents to be submitted with an IVDR notification
Change requests
o Declaration of Conformity (DOC);
o if applicable, a CE certificate from a notified body for IVDR conformity.
● New IVDD notifications
o product information;
o Declaration of Conformity (DOC);
o if applicable, a CE certificate from a notified body for IVDR conformity (class B, C and D) (for the content of a CE certificate, please refer to Article 48 (10) IVDR).
Documents to be submitted with an MDR notification
Change requests
o Declaration of Conformity (DOC);
o if applicable, a CE certificate from a notified body for MDR conformity.
● New MDR notifications
o product information;
o Declaration of Conformity (DOC);
o if applicable, a CE certificate from a notified body for MDR conformity (Class I sterile (Is), measuring function (Im) or reusable (Ir) (for the content of a CE certificate, please refer to Article 52(7) MDR).
Documents to be submitted for an MDD export declaration
• A Declaration of Conformity (DOC) with the MDD.
• For upclassified products: an EU Declaration of Conformity that has been compiled before 26 May 2021.
• If applicable, a CE certificate from a notified body.
Documents to be submitted for an MDR export declaration
• a Declaration of Conformity (DOC) with the MDR;
• if applicable, a CE certificate from a notified body for MDR conformity (Class I sterile (Is), measuring function (Im) or reusable (Ir) (for the content of a CE certificate, please refer to Article 52(7) MDR).
Documents to be submitted for an IVDD export declaration
• Declaration of Conformity (DoC) (for IVD low risk – self-test, other – a copy of the DoC);
• a CE certificate from a notified body in the case of high risk IVDs (list A or B);
• for products that are upclassified under the IVDR: an EU Declaration of Conformity that has been compiled before 26 May 2021.
Documents to be submitted for an IVDR export declaration
• a Declaration of Conformity (DOC) with the IVDR;
• if applicable, a CE certificate from a notified body for IVDR conformity (class B, C and D) (for the content of a CE certificate, please refer to Article 48(10) IVDR).
Product list and/or production site appendix
If you wish to add an appendix with a product list and/or production site to your export declaration, you must upload this information as a separate document. While you are completing the online request, select draft and add a new document with the subject line ‘please add as appendix’. You can add one appendix containing no more than 15 pages of A4. Provide the product list and/or name and address details of the production site* in a plain Word document (no company information, logo’s or similar), using font type Verdana and font size 9. If the appendix concerns a product list, the statement ‘See product list’ will be added on the front page of the export declaration.
If you would like to include a product list and/or a production site, you must submit a separate request by letter or by email. You must then upload this letter or email as part of your notification request for your medical device.
*The name and address of the production site must also appear on the DoC and/or CE certificate.