Medical devices Free Sales Certificate

When exporting medical devices to non-EU countries, it may be necessary to request a certificate of free sale (export declaration). This declaration states that the listed product may be freely traded on the EU market.

MDD Export Declarations

If your product is a medical device in accordance with the MDD or AIMDD, you will be able to request an export declaration in NOTIS until you withdraw your product from the market, subject to the following conditions: externe links onder A
•    The medical device must be compliant with the directives on medical devices (MDD or AIMDD) and must have been put onto the market prior to 26 May 2021, the date on which the MDR entered into force.
•    No significant modifications may be introduced to the device.
•    The medical device concerns a device that is compliant with the directives on medical devices (MDD or AIMDD) and will be upclassified under the MDR (in accordance with Article 120(3) MDR).
•    Export declarations for medical devices and procedure packs containing an MDD-compliant medical device can be issued until 26 May 2024 at the latest or until the expiry date on the CE certificate issued.
•    Export declarations issued will be valid for a maximum of 5 years or until the expiry date on the CE certificate issued.
The required documents are listed on this page.

MDR Export Declarations

Export declarations issued for MDR-compliant medical devices will be valid for a maximum of 5 years or until the expiry date on the CE certificate issued.
The required documents are listed on this page.


IVDD Export Declarations

If your product is an IVDD-compliant in vitro diagnostic medical device that is categorised as risk class A ‘non-sterile’ under the IVDR, you will be able to request an export declaration until 19 May 2022.
If your product is an IVDD-compliant in vitro diagnostic medical device that is categorised as a higher risk class under the IVDR, export declarations will be subject to the following transitional periods, on the proviso that your product remains compliant with the IVDD and no significant modifications are made to it:
•    If your product is an IVDD-compliant in vitro diagnostic medical device that belongs to IVDR risk class D, you will be able to request an export declaration until 19 May 2025.
•    If your product is an IVDD-compliant in vitro diagnostic medical device that belongs to IVDR risk class C, you will be able to request an export declaration until 19 May 2026.
•    If your product is an IVDD-compliant in vitro diagnostic medical device that belongs to IVDR risk class A ‘sterile’ or B, you will be able to request an export declaration until 19 May 2027.

•    After 26 May 2022, no export declaration will be issued for procedure packs that contain an IVDD-compliant IVD in respect of which the transitional periods do not or no longer apply.
•    Export declarations issued in relation to IVDD List A, List B or self-tests will be valid for a maximum of 5 years or until the expiry date on the CE certificate issued.
The required documents are listed on this page.

IVDR Export Declarations

Export declarations issued for IVDR-compliant in vitro diagnostic medical devices will be valid for a maximum of 5 years or until the expiry date on the CE certificate issued.
The required documents are listed on this page.


General comments regarding export declarations

•    For medical devices in accordance with the MDD, AIMDD or IVDD, an export declaration can only be issued on the basis of national stipulations supporting the MDD, AIMDD or IVDD.
•    For medical devices in accordance with the MDR or IVDR, an export declaration can only be issued on the basis of national stipulations supporting the MDD (Art. 60) or IVDR (Art. 55).
•    Assemblers of systems or procedure packs (SPPP), importers and distributors cannot apply for export declarations in accordance with the MDR (Article 60) or IVDR (Article 55).
•    Legacy Devices: Export declarations for medical devices that were certified in accordance with the directives and that continue to be marketed on the basis of Article 120(3) MDR or Article 110(3) IVDR (which are also referred to as Legacy Devices) can only be issued on the basis of the MDD, AIMDD or IVDD.
•    Legacy Devices: Export declarations for systems or procedure packs containing a legacy device can only be issued on the basis of the MDD, AIMDD or IVDD.


Requests for export declarations can be submitted to Farmatec

You must request an export declaration online using NOTIS. You will also need to include the required documents. To be able to log in, you will need a Level 2+ eRecognition token.
By default, the export declaration will only list the group name and brand name. If you would like to have additional information added to the export declaration, you can submit a separate request. The required documents are listed on this page.

Submit this together with your online request (see the Product List and/or Production Site appendix).


Legislation and regulations

In your application for an export declaration, you must indicate the legislation or regulations with which your product complies:
•    European Directives 93/42/EEC (MDD), 90/385/EEC (AIMDD) and 98/79/EC (IVDD);
•    Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).


Documents

When requesting an export declaration, there are a number of documents you must upload along with your online request. If these documents are missing, your request will not be processed.
The required documents are listed on this page.


Costs

Farmatec will apply a fee of €62 per export declaration. Farmatec will charge administration costs of €62 for each invoice. Invoices are sent in the next quarter.


Processing period

If your application includes all information and all the required documents, you will receive your export declaration within 4 weeks.