Medical devices illustration

Operators' obligation to submit a notification

Operators’ obligation to submit a notification

Actor module

The following economic operators established in Finland referred to in the regulations on medical devices shall register in the Eudamed database: 

  • MDR/IVDR a manufacturer or importer that places medical devices on the market in the European Economic Area; 
  • MDR/IVDR an authorised representative; 
  • a system or procedure pack assembler, or steriliser thereof; and 
  • the manufacturer of a custom-made device, if a notified body has been used in the conformity assessment of the device.

The obligation to submit a notification to Eudamed also pertains to the ‘legacy actors’ under Article 120 of Regulation 2017/745 and Aricle 110 of Regulation 2017/746.

The economic operator shall state all the information defined as mandatory in the Eudamed database.

Importers are to link themselves to the manufacturer whose medical devices they import. This is done in Eudamed. If the manufacturer has yet to register themselves in Eudamed, the linking is done by notifying Fimea using an Excel form: Importer’s Linked Manufacturers - Form E (Excel) (only in Finnish)

The operators liable to file a notification shall keep up to date the data they have declared to Fimea. Any material changes to the registered data shall be notified to Fimea without delay.

Documents and instructions:

Fimea’s instructions for submitting a notification to the actor module (pdf)

Käyttöopas talouden toimijoille (European commission)
EUDAMED Mandate Summary document that a non-EU manufacturer should provide in its Actor registration request(European commission)
ACTOR MODULE FAQs (European commission)
User's rights and obligations (European commission)
Declaration on information security responsibilities (European commission)

Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR, MDCG 2021-13 (European commission)

Actor registration module (European commission)

UDI/device module

The device module of Eudamed was introduced on the 4th of October, 2021. An actor (established in Finland) liable to submit a notification to Eudamed shall, before placing on the market the medical device manufactured, imported, represented or sterilised by the same, notify all the information concerning the device that has been marked as mandatory in the Eudamed-UDI/device module.

The device information shall be submitted to the Eudamed database no later than within 60 days of the date when the device module of the Eudamed database had been put into service. 

Importers are to link themselves to the manufacturer whose medical devices they import. This is done in Eudamed. If the manufacturer has yet to register themselves in Eudamed, the linking is done by notifying Fimea using an Excel form: Importer’s Linked Manufacturers - Form E (Excel) (only in Finnish)

Instructions:

Fimean ohje talouden toimijoille Eudamedin laiterekisteröintiin (pdf) (only in Finnish)

UDI/Device user guide (European commission)

UDI/Devices registration (European commission)

MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (European commission)

Links

Log in to EUDAMED (European commission)

Read more

Administrative Regulation 2/2021, Operator and device register notifications related to medical devices to the authorities

EUDAMED (Euroopan komissio)

Unique Device Identifier - UDI (European commission)

Unique Device Identification (UDI) Helpdesk (European commission)

Unique Device Identification (UDI) System (European commission)

UDI Helpdesk (European commission)

Management of Legacy Devices MDR EUDAMED (Euroopan komissio)

European Medical Device Nomenclature (EMDN) (Euroopan komissio)