Documents required for notifications and Free Sales Certificates

In order to submit a notification of products or apply for a Free Sales Certificate, you must upload a number of documents along with the online application. Without these documents we will not be able to process your application.

Notifications

For a product notification you must add scans in NOTIS of:

  • Product information which is intended for the market which clearly shows the medical use and the risk class of the products for which notification is being submitted. This may be a brochure, packaging text or handbook.
  • Declaration of Conformity (DOC). Below you can read which information a DOC has to contain.
  • A valid CE certificate in accordance with the New Commercial Register [Nieuwe Handelsregister] (NHR) in the case of class Is/Im/Ism (sterile and measuring function) and IVDs list A and list B and self testing.

Free Sales Certificate

You must submit the following documents along with an application for a Free Sales Certificate:

A class I medical device:

  • A Declaration of Conformity.

A low-risk in vitro diagnostic medical device, a copy of:

  • A Declaration of Conformity.

As from class Is/Im/Ism, active implantable medical devices (AIMD) and IVDs with a high risk (lists A or B):

  • A Declaration of Conformity.
  • A CE certificate from a Notified Body. Below you can read which information a CE certificate has to contain.

Which information does a Declaration of Conformity (DoC) have to contain?

  • The manufacturer's name and address details.
  • The Directive relating to the product.
  • The date of issue and signature of an authorised person.
  • The product notification.
  • The name and address details of the Authorised Representative (if applicable).
  • Any production locations.

Which information does a CE certificate have to contain?

  • The manufacturer's name and address details.
  • The Directive relating to the product.
  • The date of issue and signature of an authorised person.
  • The product notification.
  • Any production locations.

A CE certificate must be issued by a notified body

Product list and/or production location annex

If you want to add a product list and/or production location as an annex to the Free Sales Certificate, you must upload this as a separate document. To do so choose draft/example during the online application, add a new document with subject line 'please add as annex'. A single annex of no more than 15 A4s is possible. Submit the product list and/or the name and address details of the production location* in a Word document without any company information, logos, etc. using the Verdana 9 font. If the annex is a product list, the words 'See product list' will be stated on the front of the Free Sales Certificate.

If you want to add a production list and/or production location, you must submit a separate request in a letter or email. You must upload this email or letter along with your online application for the notification of medical devices.

*The name and address details of the production location must also be stated on the DoC and/or CE certificate.