Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
May 25, 2026
Approximately 5 minutes
Public Access to Details of CERE-Registered Medical Device Operators in Finland
Public Access to Details of CERE-Registered Medical Device Operators in Finland
1. Overview of Public Access to CERE Data
Fimea maintains Finland's national CERE register for certain medical device operators not required to register in EUDAMED. To ensure equal treatment, Fimea publishes details of CERE-registered operators publicly in list format, as operator details in EUDAMED are also publicly available. Source: Fimea - Details of registered operators (https://fimea.fi/en/medical-devices/registrations/details-of-registered-operators)
This publishing puts all operators on an equal footing. Source: Fimea - Details of registered operators (https://fimea.fi/en/medical-devices/registrations/details-of-registered-operators)
2. Operators Included in Public CERE Lists
The published lists cover:
- Distributors that make devices available to retailers, healthcare and social welfare operators, and other professional users
- Finnish manufacturers of custom-made devices
- Health institutions that manufacture medical devices in-house (self-manufacturers)
Source: Fimea - Details of registered operators (https://fimea.fi/en/medical-devices/registrations/details-of-registered-operators)
Note: Manufacturers, authorised representatives, importers, and system/procedure pack producers register in EUDAMED, where public search is available. Source: Fimea - Details of registered operators (https://fimea.fi/en/medical-devices/registrations/details-of-registered-operators)
3. How to Access the Public Lists
There is no direct searchable database for CERE. Instead, Fimea publishes static PDF lists updated on the first business day of each month. The update date appears in the upper right corner of each file.
Current lists (as of latest update):
- List of distributors: https://fimea.fi/documents/147152901/159459731/Jakelijalista_EN.pdf/fd0934c0-615f-65fb-9d53-cd80193249b0/Jakelijalista_EN.pdf?t=1769755659831
- List of Finnish manufacturers of custom-made devices: https://fimea.fi/documents/147152901/159459731/CMDjalista_EN.pdf/e07fdf92-74b1-3289-04d7-715c43b3162a/CMDjalista_EN.pdf?t=1769755660245
- List of health institutions manufacturing in-house: https://fimea.fi/documents/147152901/159459731/Omavalmistajalista_EN.pdf/0bf9f17a-1be2-9833-a19b-be0a2724a207/Omavalmistajalista_EN.pdf?t=1769755660620
Source: Fimea - Details of registered operators (https://fimea.fi/en/medical-devices/registrations/details-of-registered-operators)
For broader EU data, search the public EUDAMED at https://ec.europa.eu/tools/eudamed/#/screen/home. Source: Fimea - Details of registered operators (https://fimea.fi/en/medical-devices/registrations/details-of-registered-operators)
4. Limitations of the Public CERE Lists
- Not all distributors are required to notify Fimea.
- Lists may be incomplete due to a two-week processing time for notifications.
- Data is based solely on operator-submitted notifications.
Source: Fimea - Details of registered operators (https://fimea.fi/en/medical-devices/registrations/details-of-registered-operators)
5. Obtaining Up-to-Date Information
For the most current details, contact Fimea directly:
- Email: [email protected] (preferred for operator registration inquiries)
- Phone: 029 522 3341 (switchboard; request medical device operator registrations)
- General inquiries: [email protected]
Source: Fimea - Details of registered operators (https://fimea.fi/en/medical-devices/registrations/details-of-registered-operators)
Operators should submit/update notifications via the CERE e-submission system. See guidance at https://fimea.fi/en/medical-devices/registrations/device-and-operator-notifications-to-cere. Source: Fimea - Details of registered operators (https://fimea.fi/en/medical-devices/registrations/details-of-registered-operators)
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
Obligations for Medical Device Distributors and Importers in Finland
In Finland, distributors and importers of medical devices must comply with MDR and IVDR obligations, including verification of conformity, proper storage/transport, language requirements in Finnish and Swedish, and vigilance reporting to Fimea.
Approximately 5 minutes
Regulation of Products without Intended Medical Purpose in Finland
In Finland, products without an intended medical purpose listed in Annex XVI of the MDR are regulated as medical devices, subject to conformity assessment, CE marking, and common specifications, with transitional provisions until June 2028.
Approximately 5 minutes
Clinical Evaluation and Investigations for Medical Devices in Finland
In Finland, clinical investigations for medical devices under MDR require notification or authorisation from Fimea, with coordinated ethical review, specific documentation, and reporting obligations for safety and completion.
Approximately 5 minutes
Advertising and Promotion Requirements for Medical Devices in Finland
In Finland, advertising of medical devices must comply with MDR/IVDR Article 7 and national law, prohibiting misleading claims, requiring indication of CE marking and manufacturer details, and ensuring information targets the correct user group.
Approximately 5 minutes
EUDAMED Registration Requirements for Medical Device Operators and Devices in Finland
Finnish operators under MDR/IVDR must register actors and devices in EUDAMED or the national CERE register depending on role; manufacturers, authorised representatives, importers, and certain others register directly in EUDAMED.