Fees

Manufacturers and authorised representatives (AR/EC REP) of medical devices (including custom made devices) that are established in Sweden are required to pay fees to the Medical Products Agency. During a transitional period, there will be different fees for devices placed on the market according to the regulations MDR/IVDR and for legacy devices placed on the market according to the transitional provisions. Manufacturers of national medical information systems (“NMI”) are also required to pay a fee.

Fees for free sale certificates and derogations are described under the heading Specific fees.

Annual fees

Manufacturers and ARs that are established in Sweden shall pay an annual fee. This includes manufacturing of and being the AR for:

• medical devices CE-marked according to MDR or IVDR
• custom-made devices according to the MDR
• NMI according to national legislation HSLF-FS 2022:42.

An annual fee is issued for each actor role registered by a physical or legal person. Hence, a single physical or legal person may be required to pay more than one annual fee.

Annual fees will still be issued when registration is done through the European database Eudamed. According to MDR and IVDR, member states may issue fees for their operations and use data in Eudamed for this reason.

Invoicing

Invoices for annual fees are sent in February. For new registrations done during the year, you will be invoiced from the month following your registration and until the end of the year. If you for example register in May, you will be invoiced for the period June to December.

Invoicing for derogations and free sale certificates is done when each case is handled. Legacy devices (i. e. products placed on the market according to the transitional provisions in MDR or IVDR) are invoiced annually according to the previous model.
You are responsible for keeping your contact details and billing information up to date in MPA’s registry.

If the fee is not paid before the due date on the invoice, MPA will send one reminder. If the fee still is not paid, after the reminder, the unpaid invoice may be handed over to debt collection (“inkasso”). If you need to split the payment through a payment plan, you can apply for this be sending an email to finance@lakemedelsverket.se.

Application for reduction of annual fee

Special reasons

If there are special reasons in an individual case, the MPA may, fully or partly, repay or reduce of the annual fee, see Chapter 5, Section 2 of the Regulation on Medical Device Fees (Swedish Code of Statues – SFS, 2021:988).

The assessment of what can be considered to constitute such special reasons for reducing the annual fee is restrictive. There is no legal preparatory work for the regulation.

The MPA has, in some cases, decided not to reduce the fee for some actors who have applied for a reduction. Several decisions have been appealed to the Swedish Administrative Court (Förvaltningsrätten). The Court has, in the cases where decisions have been made until January 2024, made the assessment that a low revenue or income in itself is not a sufficient special reason for fee reduction. The majority of the decisions made by the Administrative Court have not been appealed.

Who can apply and how to apply

You as an actor must apply for a reduction yourself and show why you believe there are special reasons for the fee to be reduced. We recommend that you wait until you receive the invoice for the annual fee, before you submit your application for reduction.

If you wish to apply for a reduction in connection to a deregistration, we recommend that you submit your application immediately after your deregistration, since a deregistration is taken into consideration when handling applications.

Applications for fee reduction should be sent to registrator@lakemedelsverket.se. No specific form is required.

Conditions for deregistration

When you have terminated or transferred your business (including bankruptcy), you must deregister from MPA’s registry. If a deregistration is done before February 1st, no annual fee will be invoiced. No products may be placed on the market (sold) after a deregistration.

If you terminate or transfer your business and deregister after January 31st, but have already paid the annual fee for the year, you may apply for a reduction of the annual fee after your deregistration, as described above.

The MPA has made the assessment that a deregistration of the business in our registry can be reason for a fee reduction. According to agency praxis, you pay for the months during which you are registered.

Specific fees

Derogations

A fee is issued for each application for derogation from the conformity assessment procedures according to articles 59 (MDR) and article 54 (IVDR).

There is currently no fee for application for derogation from the language requirements in the Swedish national legislation.

Certificates of free sales

There are fees for the issuing of certificates of free sales according to article 60 (MDR) and article 55 (IVDR). Amended certificate means certificates where the applicant desires extended information, e.g. information on the physical manufacturer. The regulation uses the term “copies”, meaning identical documents.

There are different fees for the first copy and the following identical copies. Each copy issued by the Medical Products Agency is an equally valid document.

Other special fees for medical devices

Aside from the fees described above, there are also other fees related to medical devices. Please find further information on the websites listed below.

Legacy devices

Manufacturers and ARs for manufacturers of legacy devices are charged with the following fees.

Fees are determined according to national legislation on medical devices (1993:876).

Rules for fees

Medical devices placed on the market entirely according to MDR or IVDR.

Devices placed on the market according to the transitional provisions (legacy devices) in MDR or IVDR, and devices placed on the market according to IVDD.

New fees from 2022

The reason for why the annual fee for manufacturers was increased in 2022 is that a new model for fees applies for the MPA. The model means that a greater proportion of the MPA's tasks must be financed through fees instead of grants, that is, through government funding. The Swedish government decides on the fees to be taken. For medical devices, this is based on national Swedish regulation (2021:988) on fees for medical devices.

Report on fee changes

During 2018–2019, the Medical Products Agency had a government assignment to provide input for, inter alia, cost calculations and a proposal for a fee model. This resulted in a report.