The following entities are entered in the register of manufacturers of medical devices:
- manufacturers of medical devices with a registered office in the Republic of Slovenia,
- authorised representatives of manufacturers of medical devices with a registered office in the Republic of Slovenia,
- legal entities which compose, pack, process or completely modify or label one or more ready-made products or assign to them their intended purpose of performance or use as a medical device, or sterilise them, all for the purpose of placing on the market under their own name.
Legal entity which is entered into the aforementioned register must meet the provisions of the medical Products Act (Official Gazette of the Republic of Slovenia No. 98/09) and Rules on manufacturing and marketing medical devices (Official Gazette of the Republic of Slovenia, No. 37/10).
Manufacturer of medical devices is a legal entity responsible for designing, manufacturing, packaging and labelling of a medical device before it is placed on the market under its own name, regardless of whether these operations are carried out by that entity or by a third party on their behalf.
Authorised representative of the manufacturer of medical devices shall mean a legal entity established in the European Union, which is explicitly authorised in writing by a medical device manufacturer established in a third country to represent it, and who Competent Authorities may turn to relating to the obligations of Medical device manufacturer.
Legal entities which compose, pack, process or completely modify or label one or more ready-made products or assigns to them their intended purpose, operation of performance or use as a medical device, or sterilises them, all for the purposes of placing on the market under their own name must fulfil the obligations from this act that apply to manufacturers of medical devices.
PROCEDURE FOR ENTRY, AMENDMENT AND DELETION FROM THE REGISTER OF MANUFACTURERS OF MEDICAL DEVICES
Entry into the register is performed on the basis of an application of the applicant, which may be filed on the proposed application forms within 15 days of taking up the activity.
Entering an amendment into the register is performed on the basis of an application of the applicant, which may be filed on the proposed application forms within 15 days from the day of the amendment entering into force.
Deletion from the register is performed on the basis of a written request of the applicant, which must include the act of authority for operation of the legal entity or any other document which presents termination of operation of the appropriate activity or termination of operation of the legal entity.
COSTS OF THE PROCEDURE
Costs of the procedure of entry, amendment or deletion from the register of manufacturers of medical devices, in accordance with the Administrative Fees Act (Official Gazette of the Republic of Slovenia, No. 106/2010 – official consolidated text, 14/15 – ZUUJFO, 84/15 – ZZeIP-J IN 32/16) amount to 4.50 EUR and must be transferred to the following account:
Account number: 01100-1000315637, reference number: 11 27650-7111002 with the beneficiary of the payment: Administrative fee – national Ljubljana (mandatory!)
Receipt against payment must be included in the application as proof.
For notifying the entry, amendment of information or deletion from the aforementioned register, please complete the following forms and annexes:
- FORM A – Entry into the register of manufacturers of medical devices
- ANNEX 2 – Classification of medical devices
In instances where the manufacturing activity is carried out in several locations, please also complete Annex 1
If you need the confirmation of entry, please also complete the form below. Confirmations of entry are not issued ex officio, but only at the request of the client.
With the application for a certificate, a confirmation of a current entry is obtained. The certificate is issued at the request of the applicant within 15 days from receiving the claim and is free of charge.