Supervision fees for medical devices will be sent to operators in late August and early September

The Medical Devices Act (719/2021) entered into force on 19 July 2021 and, in accordance with section 50 thereof, Fimea will charge a supervision fee from the medical device operators in Fimea's register. The supervision fee is charged from each of the registered roles separately.

Invoices for supervision fees will be sent to operators for the first time at late August and early September 2022.

With a few exceptions, the supervision fee to be sent is based on the number of devices declared at the end of 2021, with a few exceptions, as follows:

• maximum of 10 devices €500
• 11 to 50 devices €1,000
• 51 to 100 devices €2,000
• 101 to 500 devices €4,000
• more than 500 devices €6,000

The exception is the distributor and the producer of the sterilisation service.  This year, the distributor will be charged a supervision fee of €500 and the sterilization service provider €1,000.

The supervision fee is used to cover the increased costs of statutory official duties for medical devices as a result of the MD and IVD regulations.