Certificate of free sale

The certificate is sent as a letter and states that the device may be sold in the EU/EEA. In some cases, the importing country requires such a certificate. A certificate of free sale is not required if the device does not leave the EU/EEA.

Who can apply for a certificate of free sale?

Applications can be made by:

• a Swedish legal manufacturer
• a Swedish authorised representative if the manufacturer is based outside the EEA.

The applicant must be registered with the Swedish Medical Products Agency (MPA).

Applicants must ensure that the information stated in their registration with the Swedish MPA agrees with the application for a certificate of free sale, for example in the product list, submitted certificates and the EU declaration of conformity. The Swedish MPA will check this information before a certificate of free sale is issued.

The Swedish Medical Products Agency does not issue certificates of free sale to distributors or importers. For assemblers of systems or procedure packs according to article 22 in MDR, the Swedish MPA may instead issue a statement letter to.

Apply for a certificate of free sale

For each new certificate of free sale, a new complete application must be submitted. Different types of application require different templates for the certificate of free sale to be issued:

• send one (1) application form with one (1) device list as an attachment in one (1) email, as this makes it easier to process the application
• devices regulated under different legislations must not be combined in the same device list
• complete applications must be sent by email to exportintyg@lakemedelsverket.se.

Fees

Applications for certificates of free sale for CE‍-‍marked devices under Article 60 of the MDR and Article 55 of the IVDR are subject to a fee.

Devices CE‍-‍marked under MDR

The content of this type of certificate of free sale is regulated by Article 60 of the MDR. If you wish to add content beyond what is required in Article 60, this must be stated in the application. The application then becomes an "Application for an extended certificate of free sale", more information below.

For the purpose of export and upon request by a manufacturer or an authorised representative, the Member State in which the manufacturer or the authorised representative has its registered place of business shall issue a certificate of free sale declaring that the manufacturer or the authorised representative, as applicable, has its registered place of business on its territory and that the device in question bearing the CE marking in accordance with the MDR may be marketed in the European Union.

The certificate of free sale must indicate the device’s unique device identifier (UDI‍-‍DI). See below for more information about UDI‍-‍DI.

Where a notified body has issued a certificate pursuant to Article 56, the certificate of free sale shall set out the unique number identifying the certificate issued by the no tified body as referred to in Section 3 of Chapter II of AnnexXII.

Only MDR devices should be listed in this application form. For each new certificate of free sale, a new complete application must be submitted.

Devices CE‍-‍marked under IVDR

The content of this type of certificate for free sale is regulated by Article 55 of the IVDR. If you wish to add content beyond what is required in Article 55, this must be stated in the application. The application then becomes an "Application for an extended certificate of free sale", more information below.

For the purpose of export and upon request by a manufacturer or an authorised representative, the Member State in which the manufacturer or the authorised representative has its registered place of business shall issue a certificate of free sale declaring that the manufacturer or authorised representative, as applicable, has its registered place of business on its territory and that the device in question bearing the CE marking in accordance with the IVDR may be marketed in the European Union.

The certificate of free sale must indicate the device’s unique device identifier (UDI‍-‍DI). See below for more information about UDI‍-‍DI.

Where a notified body has issued a certificate pursuant to Article 51, the certificate of free sale shall set out the unique number identifying the certificate issued by the notified body as referred to in Section 3 of Chapter II of Annex XII.

Only IVDR devices should be listed in this application form. For each new certificate of free sale, a new complete application must be submitted.

Systems and procedure packs

Natural and legal persons that combine devices within the meaning of Article 22 of the MDR are not considered to be manufacturers, and therefore cannot obtain a certificate of free sale under Article 60 of the MDR.

It is possible to apply for statement letter issued according to the Swedish MPA’s procedures t for devices under the Directives.

Statement letter

The content of a statement letter for systems or procedure packs under Article 22 of the MDR differs from those issued under Article 60 of the MDR. Article 60 of the MDR allows the competent authority to issue certificates of free sale only to manufacturers and authorised representatives.

CE-marked legacy devices

Certificates of free sale for legacy devices under the MDD, AIMDD and IVDD, are issued free of charge and the content differs from certificates of free sale issued according to MDR or IVDR. Based on this, it is not possible to mix devices which are CE marked according to MDR or IVDR with devices which are CE marked according to MDD, AIMDD or IVDD in one application and product list.

Legacy devices are devices which are CE marked according to MDD, AIMDD or IVDD and which, according to the transitional rules, may continue to be placed on the market during the transitional period, provided that the conditions states in article 120 of MDR and article 110 of IVDR are fulfilled.

Certificates of free sale for legacy devices will be issued by the Swedish MPA according to procedures for the directives (MDD, AIMDD and IVDD). From September 26th 2024, additional documentation is required. Follow the instructions provided in the application form and attach the documents requested.

Only MDD, AIMDD and IVDD legacy devices should be listed in this application form. For each new certificate of free sale, a new complete application must be submitted.

Period of validity and language

The Swedish Medical Products Agency no longer states the period of validity on certificates of free sale. The Swedish Medical Products Agency can only certify information at the date of issue and is not responsible for monitoring whether an applicant company meets the requirements of the regulatory framework after the certificate has been issued.

The certificate of free sale is issued in English only.

Basic UDI‍-‍DI – Unique device identifier

The basic UDI‍-‍DI, which is the primary identifier of a device model, shall be indicated in relevant certificates and EU declarations of conformity. The basic UDI‍-‍DI will be indicated in certificates of free sale issued under Article 60 of the MDR and Article 55 of the IVDR.

Information on extended certificate of free sale

An extended certificate of free sale may contain for example information on the physical manufacturer of the devices, if desired. In this case, you should tick the ‘Extended certificate of free sale’ box on the application form.

If this information is desired, the following applies:

• the name and address of the physical manufacturer to be indicated on the certificate must be indicated in the device list annexed to the application
• agreements or certificates verifying the physical manufacturer must be annexed to the application.

Processing

Applications are processed in the order in which they are received. The processing time is normally three weeks if the application is complete.

Legislation

Information about legislation is currently only available in Swedish: