Medical devices Free Sales Certificate

MDD and AIMDD Export Declarations

If your product is a medical device in accordance with the MDD or AIMDD directives and:

• has your medical device a CE certificate issued by a notified body under the MDD or AIMDD after 25 May 2017, which was still valid on 26 May 2021 but expired before 20 March 2023;
• or your medical device did not mandate the involvement of a notified body for the conformity assessment procedure under the MDD directives, but does mandate the involvement of a notified body for the conformity assessment procedure under the the MDR (meets the requirements for legacy devices as described in Article 120(3c) MDR)

Then you will be able to request an export declaration in NOTIS.

As the MDR transitional periods have changed and additional conditions have been imposed (see updated transitional periods – (EUR-Lex - 32023R0607 - EN - EUR-Lex (europa.eu), the CIBG expects to receive the following documentation/evidence if you want to receive an export declaration that is valid for a maximum* of 5 years. If you are unable to submit these documents, it is not possible to apply for an export declaration.

The following conditions apply here:

• A Declaration of Conformity (DoC) with the MDD or AIMDD. 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 of application of the MDR.
• The medical devices have not undergone any 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 introduced a quality management system by 26 May 2024 in accordance with Article 10(9) MDR.
• The manufacturer or authorised representative must have submitted a formal request for a conformity assessment from a notified body by 26 May 2024.
• 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 (view format Notified Body confirmation letter).

Issuance of export declarations

Export declarations for medical devices and procedure packs containing an MDD-compliant device and which meet the above mentioned conditions can be issued until:  

• For class III medical devices and class IIb implants with the exception of sutures, staples, dental fillings, dental braces, crowns, screws, wedges, plates, wires, pins, clips and connectors, you will be able to request an export declaration until 31 December 2027 provided you meet the above conditions and are able to submit the corresponding evidence.
• For other class IIb medical devices, class IIa medical devices and class I devices that are sterile or have a measuring function, you will be able to request an export declaration until 31 December 2028 provided you meet the above conditions and are able to submit the corresponding evidence.

For the above products, a manufacturer or authorised representative registered in the Netherlands will be able to apply to Farmatec for an export declaration in NOTIS until the specified periods.

The required documents are available 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 available on this page.

IVDD Export Declarations

If your product is an IVD device in accordance with the IVD directives and:

• The medical device must be compliant with the In Vitro Diagnostica directives (IVDD) and must have been put onto the market prior to the date of application of the IVDR.
• And your medical device did not mandate the involvement of a notified body for the conformity assessment procedure under the IVDD directives, but does mandate the involvement of a notified body for the conformity assessment procedure under the the IVDR.

Your IVD falls under the category legacy devices and you are ably to apply for an export declaration. As the IVDR transitional periods have changed and additional conditions have been imposed (Regulation (EU) 2024/0021) the CIBG expects to receive the following documentation/evidence if you want to receive an export declaration.

• A Declaration of Conformity (DoC) with the IVDD. The medical device must be compliant with the directives on medical devices (IVDD) and must have been put onto the market prior to 26 May 2022, the date of application of the IVDR.
• The medical devices have not undergone any significant changes
• The manufacturer must have introduced a quality management system by 26 May 2025 in accordance with Article 10(8) IVDR
• The manufacturer or authorised representative must have submitted a formal request for a conformity assessment from a notified body by op 26 May 2025 for class D, 26 May 2026 for class C, 26 May 2027 for class A sterile and B.
• After 4 months, the manufacturer has a notified body confirmation letter confirming the manufacturer wants the medical device certified in accordance with the IVDR.

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 2027.
• 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 2028.
• 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 2029.

If you are unable to submit a manufacturers declaration and/or agreement, your export declaration will be subject to the following periods:

• 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.

For the above products, a manufacturer or authorised representative registered in the Netherlands will be able to apply to Farmatec for an export declaration in NOTIS until the specified periods.

The required documents are available 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 available on this page.

General comments regarding export declarations

• Compilers 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.

Requesting export declarations for products in EUDAMED

You can also request export declarations for products that are registered in EUDAMED. You can select these products in NOTIS for the ‘Class’ under the Product Details (E AIMD, E MDD, E MDR, E IVDD and E IVDR).
In addition to the standard document requirements, confirmation of registration of the products in EUDAMED is required, plus a product list as an appendix to the export declaration.

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 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 available 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.