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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/regulation 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/regulation 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 (Notified body)

Documents/declarations to be submitted with a legacy notification

  • the medical device must be compliant with the directives on medical devices (MDD or IVDD) and must have been put onto the market prior to 26 May 2021, the date of application of the MDR, or 26 May 2022, the date of application of the IVDR;
  • no significant modifications may be introduced to the device (see format 'Manufacturer's Declaration' on the websites of Trade Associations AESGP, COCIR, EuromContact, EUROM VI en MedTech Europe);
  • the manufacturer must have demonstrably introduced a quality management system by 26 May 2024 in accordance with Article 10(9) MDR; (Demonstrable means have available at the request of the inspectorate/during an inspection).
  • the notified body and the manufacturer must have signed a written agreement by 26 September 2024 to have the medical device certified in accordance with the MDR. Please send us a copy of this agreement (see format Notified Body confirmation letter).
  • the medical device concerns a device that is compliant with the directives on medical devices (MDD/IVDD) and will be upclassified under the MDR/IVDR (in accordance with Article 120(3) MDR/Article 110(3) IVDR).

Notification of a legacy device previously registered with another EU Member State authority

In addition to the above, these medical devices must also meet the following requirements:

  • the product as in the transition period described in the MDR/IVDR must be adopted by a European authorised representative registered in the Netherlands. The applicant must provide a declaration to this end;
  • the authorised representative registered in the Netherlands must include in the notification request a declaration of conformity drawn up before the date of application of the MDR/IVDR;
  • the product must have been adopted from a European authorised representatives from another EU Member State. The applicant must submit proof of registration showing that the product was registered with an EU Member State authority before the date of application of the MDR/IVDR.

Change requests

  • Declaration of Conformity (DOC)
  • If applicable, a CE certificate from a notified body for MDR/IVDR conformity.

New IVDR notifications

  • product information;
  • Declaration of Conformity (DOC);
  • 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

New MDR notifications

  • product information;
  • Declaration of Conformity (DOC);
  • 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 or AIMDD export declaration

Conditions for MDD or AIMDD export declaration without extended transition period:
  • Declaration of Conformity (DoC) to MDD.
  • For the products that comply with the MDD Medical Device Directive that will be classified under the MDR in a higher risk class (in accordance with Article 10(3) MDR):
  • an EU declaration of conformity drawn up before May 26, 2021.
  • If applicable, a CE certificate from a Notified Body for conformity to MDD (class Is/Im/Is or IIa, IIb and III).

As the MDR transitional periods have changed and additional conditions have been imposed, the CIBG expects to receive the following documentation/evidence if you want to receive an export declaration that is valid for 5 years: If you are unable to submit these documents, your export declaration will expire after 26 May 2024.

Conditions for MDD or AIMDD export declaration with extended transition period:
  • The medical device must meet the requirements for legacy devices as described in Article 120(3c) MDR (MDD or AIMDD). Please submit to us an EU declaration of conformity for these medical devices, drawn up before 26 May 2021, or a valid CE certificate if applicable.
  • The medical devices have not undergone significant changes. (see format 'Manufacturer's Declaration' on the websites of Trade Associations AESGP, COCIR, EuromContact, EUROM VI en MedTech Europe)
  • The manufacturer must have demonstrably introduced a quality management system by 26 May 2024 in accordance with Article 10(9) MDR. (Demonstrable means have available at the request of the inspectorate/during an inspection).
  • The notified body and the manufacturer must have signed a written agreement by 26 September 2024 to have the medical device certified in accordance with the MDR. Please send us a copy of this agreement (see format Notified Body confirmation letter).

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) IIa, IIb or III (for the content of CE certificate please refer to Article 52.7 of the MDR).

Documents to be submitted for an IVDD export declaration

  • a Declaration of Conformity (DoC);
  • if applicable, a CE certificate from a Notified Body for IVDD conformity (self-test, list A and list B);
  • for IVDs that fall under the transitional provisions (L_2022019NL.01000301.xml (europa.eu), an EU declaration of conformity drawn up before 26 May 2022.
     

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 a product list and/or production location as an appendix to the export declaration, you must upload this information as a separate document. When submitting the online application, choose draft/example, then add a new document with the subject line 'please add as appendix'.

The following conditions apply to adding a product list and/or production location:

  • 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. The name and address of the production site must also appear on the DoC and/or CE certificate.
  • In a plain Word document (no company information, logo’s or similar), using font type Verdana and font size 9;
  • Please keep 4 centimeters at the top of all pages of the product list free;
  • If the appendix concerns a product list, the statement ‘See product list’ will be added on the front page of the export declaration;
  • Upload a separate request (letter or email) with your online application stating that you want to add a production list and/or production location to the export declaration. In the subject line, state 'request to add product list and/or production location'.